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Protocol. | (DOCX)Click here for additional data file. | PMC10681230 | ||
Tianjin normal University scientific research ethics review form. | (DOCX)Click here for additional data file. | PMC10681230 | ||
Human research ethics approval. | (PDF)Click here for additional data file.(TIFF)Click here for additional data file. | PMC10681230 | ||
CONSORT 2010 checklist of information to include when reporting a randomised trial*. | (DOC)Click here for additional data file.The authors acknowledge the statistical support received through the Research and Statistical Support Service, Faculty of Medicine, The University of Queensland, Australia. | PMC10681230 | ||
References | PMC10681230 | |||
Keywords | hair loss | HAIR LOSS, ANDROGENETIC ALOPECIA | Androgenetic alopecia (AGA) is the most common cause of hair loss in both genders with a higher psychological impact on females. Currently, topical minoxidil is the only FDA-approved treatment for female AGA and it needs life-long application and causes side effects. Cetirizine is an antihistamine that may be effective in hair loss treatment. This study aimed to compare the efficacy and safety of topical cetirizine with minoxidil (group 1) versus topical minoxidil with placebo (group 2) in female patients with AGA. This was a double-blind, randomized, controlled, parallel study conducted at Dermatology Clinic, Cairo University Teaching Hospital (Kasr- Al- Ainy), Egypt. Sixty-six patients with female AGA, aged 20–50 years, Sinclair (II–IV), were randomly assigned to one of the 2 groups for 24 weeks. The trichoscopic parameters, patients’ self-assessment, side effects and global photographic assessment were evaluated. There was a statistically significant change from baseline in frontal and vertex terminal and vellus hair density (Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC10205881 |
Introduction | hair loss | HAIR LOSS, ANDROGENETIC ALOPECIA | Androgenetic alopecia (AGA) is the most common cause of hair loss in both genders [ | PMC10205881 |
Patients and methods | PMC10205881 | |||
Study design and study participants | hair loss, alopecia, hypersensitivity, FAGA | HAIR LOSS, ALOPECIA, HYPERSENSITIVITY, CARDIOVASCULAR DISEASE | This was a 24-week, double-blind (patient and outcome assessors), randomized, controlled, parallel study. Sixty-six patients were recruited from the Dermatology Clinic, Cairo University Teaching Hospital (Kasr- Al- Ainy), Egypt, after obtaining their written consent and after the approval of the Research Ethics Committee for Experimental and Clinical Studies, Faculty of Pharmacy, Cairo University (CL 2555). The study was registered in clinicaltrials.gov, identifier number NCT04481412.The inclusion criteria were: FAGA patients aged 20 to 50 years, experiencing active hair loss within the last year, Sinclair grade of II-IV, willing to continue their current regimen of vitamins and not start any new vitamins and to use a mild non-medicated shampoo and conditioner during the study, did not receive any topical or systemic treatment for AGA or PGs in the last 6 months. The exclusion criteria were: patients with other chronic dermatological conditions, hair transplants, scalp reduction, current hair weave or tattooing in the target area, received radiation therapy to the scalp, or had chemotherapy in the past year, had a known underlying medical problem that could influence hair growth, with clinical diagnosis of non-AGA forms of alopecia, pregnant or lactating females or planning to become pregnant during the study, with severe cardiovascular disease, with hair loss for greater than 5 years, with known hypersensitivity to any of the treatments components, using medications that induce hair loss within the last 3 months and any patients refusing to participate. | PMC10205881 |
Randomization | Patients were randomly assigned into 2 groups with a 1:1 allocation. A blocked size balanced randomization was done through the free online software “sealed envelope.” The software randomly generated numbers that indicated the specific group to which the research subject would be allocated [ | PMC10205881 | ||
Measurements | PMC10205881 | |||
Primary outcomes | hair loss rate | BALD | The changes from baseline in the terminal and vellus hairs percent and density, terminal to vellus ratio, mean hair shaft thickness and the average number of hairs per follicular unit in the frontal and vertex areas were measured at 12 and 24 weeks. Dermatoscopic examination was done using a digital dermatoscope (phototrichoscopy by FotoFinder, medicam 1000 Video dermoscopy, FotoFinder Systems GmbH, Germany, Trichoscale software, smart count mode-manual analysis) [Patient self-assessment was done every 6 weeks using predetermined 5 questions in Arabic, each of which evaluated a specific aspect of their hair compared with baseline. The questions asked about the change in hair elongation rate, new hairs, bald spots size, hair loss rate and self-satisfaction. Each of the first four questions was answered using a 7-point scale. The choices ranged from − 3 = greatly decreased to 3 = greatly increased. The fifth question was answered using a 5-point scale. The choices ranged from − 2 = very unsatisfied to 2 = very satisfied. The questions were inspired from the women’s hair growth questionnaire (WHGQ) [ | PMC10205881 |
Secondary outcomes | SIDE EFFECT | Global photographic assessment was conducted at baseline, 12 and 24 weeks at the clinic where standardized photographs of the scalp were taken. Then, a panel of 3 blinded dermatologists and the blinded outcome assessor compared baseline with follow-up photographs of each subject and used a 7-point scale to rate the hair growth. The choices ranged from − 3 = greatly decreased to 3 = greatly increased.Treatment safety was evaluated by questioning patients every 6 weeks if they had suffered from any side effects since the last interview. Patients were informed about minoxidil side effects, and if any serious side effect had occurred, patients would have been withdrawn from the study and treated for free. | PMC10205881 | |
Statistical analysis | ADVERSE EFFECTS | A priori sample size was calculated using G*Power 3.1.9.2 using the trichoscopic evaluation parameters as the primary outcome measure. A total sample size of (28) participants would be required to detect a statistically significant change using both mixed repeated measures ANOVA (RM-ANOVA) and one-way RM-ANOVA tests predicting a medium effect size of 0.25, 2 sided alpha error = 0.05, power = 80% (Statistical Package for Social Science (SPSS) version 23 (SPSS Inc., Chicago, IL, USA) was used. Qualitative data were presented as numbers and percentages, whereas quantitative data were presented as mean and standard deviation. Student’s One-way RM-ANOVA was applied to test the effect of time on numerical variables within each group individually. The mixed model of RM-ANOVA was applied to account for the time and group effect and their interaction. That was followed by pairwise comparisons with Bonferroni adjustments.The patients’ responses to the self-assessment questionnaire and the results of the outcome assessor and the dermatologists’ panel evaluation were compared between the 2 groups at 6- and 12-week intervals, respectively, using Mann–Whitney Also, the percent of subjects that reported adverse effects was compared between groups using Fisher’s exact test. All tests were two-tailed at | PMC10205881 | |
Results | PMC10205881 | |||
Global photographic assessment | The blinded outcome assessor (mean ranks: group 1 = 30.05 and The response rates to treatment based on the panel of dermatologists were measured where slight increase in hair growth = good response, moderate increase = very good and great increase = excellent. Group 1 showed excellent response in 16 patients, very good in 7, good in 2 and no change in one patient, while in group 2, 17 patients showed excellent response, 6 were very good, 4 were good and one patient showed no change. Fisher’s exact showed statistically insignificant difference between groups. | PMC10205881 | ||
Treatment safety | hair loss, itching, dandruff | HAIR LOSS, DANDRUFF | The reported side effects were itching, dry hair, initial hair loss and dandruff which are known side effects of minoxidil and the patients did not complain of any side effects after cetirizine application. There was no significant difference between groups in the number of patients with side effects ( | PMC10205881 |
Acknowledgements | We would like to thank Dr. Ashraf Wageeh, Managing Director Global Pharmaceutical Group, and Global Napi for providing us with the cetirizine powder. | PMC10205881 | ||
Author contributions | Research idea was given by HRN, conceptualization was done by all authors equally, medication preparation by EAB, random allocation, enrollment, assignment, patients questionnaires and follow-up by EAB, global photographic assessment and trichoscopic parameters outcome assessor by SIE-S, statistical analysis by EAB, manuscript writing by EAB, manuscript editing and revision by MMA, SFF. SIE-S, HRN. | PMC10205881 | ||
Funding | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). None. | PMC10205881 | ||
Data availability | Data are available on request from the authors. | PMC10205881 | ||
Declarations | PMC10205881 | |||
Competing interests | The authors declare no competing interests. | PMC10205881 | ||
Conflict of interest | None declared. | PMC10205881 | ||
Ethics approval | This study was performed in line with the principles of the Declaration of Helsinki, and the study protocol (CL 2555) was approved by the Research Ethics Committee for Experimental and Clinical Studies, Faculty of Pharmacy, Cairo University. The study was registered in clinicaltrials.gov, identifier number NCT04481412. | PMC10205881 | ||
Consent | Oral and written informed consents were obtained from all patients before enrollment. | PMC10205881 | ||
References | PMC10205881 | |||
Background | Telerehabilitation has gained significance as a tool to deliver and supervise therapy and training as effective as traditional rehabilitation methods yet more accessible and affordable. An exergame-based telerehabilitation system has recently been developed within the scope of the international Continuum-of-Care (COCARE) project. The system comprises training devices for use in clinics (Dividat Senso) and at home (Dividat Senso Flex), an assessment system, and a rehabilitation cockpit, and its focus lies on home-based motor-cognitive training, which is remotely managed by health care professionals (HPs). | PMC10739244 | ||
Objective | SECONDARY | This study aims to analyze the usability, acceptance, and enjoyment of the COCARE system from the perspective of primary (older adults [OAs]) and secondary (HPs) end users. | PMC10739244 | |
Methods | At 3 trial sites (located in Switzerland, Italy, and Cyprus), participants engaged in a single-session trial of the COCARE system, including testing of exergames and assessments. Mixed methods encompassing qualitative approaches (eg, think aloud) and quantitative measures (eg, Exergame Enjoyment Questionnaire [EEQ], System Usability Scale [SUS], and Unified Theory of Acceptance and Use of Technology [UTAUT] questionnaire) were used to analyze participants’ perceptions of the system and identify potential barriers to its implementation in a home setting. In addition, the associations of performance during gameplay and assessments, demographics, and training motivation (Behavioral Regulation in Exercise Questionnaire–3 [BREQ-3]) with usability, acceptance, and enjoyment were explored. | PMC10739244 | ||
Results | SD | A total of 45 OAs and 15 HPs participated in this study. The COCARE system achieved good acceptance ratings (OAs: 83%, range 36%-100% and HPs: 81%, range 63.8%-93.3% of the maximum score), and OAs indicated high enjoyment (mean 73.3, SD 12.7 out of 100 points in the EEQ) during the exergame session. The system’s usability, assessed with the SUS, received scores of 68.1 (SD 18.8; OAs) and 70.7 (SD 12.3; HPs) out of 100 points, with substantial differences observed between the trial sites. Several requirements for improvement were identified. Commonly mentioned barriers to adoption included the movement-recognition sensitivity of the Senso Flex, its limited markings, and difficulties in understanding certain instructions for assessments and games. Performance in games and assessments showed the highest significant correlations with the SUS (Spearman ρ=0.35, | PMC10739244 | |
Conclusions | The study’s findings will inform the further development of the COCARE system toward a user-friendly and widely accepted version, enhancing cognitive and physical functions in OAs. Future randomized controlled trials should evaluate the system’s feasibility and effectiveness. | PMC10739244 | ||
Introduction | PMC10739244 | |||
Background | -11 | In recent decades, the development of health technology systems to support patients and health care professionals (HPs) has increased dramatically. For instance, information and communications technologies (ICTs) have recently emerged as valuable tools for telerehabilitation in older adults (OAs) and various patient groups. Telerehabilitation can be defined as the delivery of rehabilitation services from a distance using ICTs [An emerging training approach that lends itself to telerehabilitation is the use of exergames (ie, interactive video games that combine motor and cognitive tasks [Although popular exergame systems such as Nintendo Wii or Xbox Kinect exist, they were not purpose developed for training OAs, potentially overlooking their unique needs. An alternative solution is the Continuum-of-Care (COCARE) system (Dividat), an exergame-based telerehabilitation system designed to meet the specific needs and requirements of OAs. Overall, the system comprises an exergame-based training tool, an assessment system, and a centralized digital case manager (rehabilitation cockpit).To ensure the usability, feasibility, and effectiveness of new technologies for rehabilitation, a user-centered design (UCD) approach is essential. UCD is defined as an iterative design process involving end users at every stage of a research and development project. This approach facilitates a comprehensive understanding of the factors influencing the use of the corresponding technology and ensures that this technology is acceptable, purposeful, usable, safe, and effective [As the next and central step in the UCD process, a usability study was conducted. Usability is defined as “the extent to which a product can be used by specific users to achieve specified goals with effectiveness, efficiency, and satisfaction in a specified context of use” (ISO 924-11) [ | PMC10739244 | |
Objectives | SECONDARY | Thus, the primary aim of this study was to assess the usability, acceptance, enjoyment, and safety of the modified COCARE system for OAs (primary end users) and HPs (secondary end users) and identify facilitators of and barriers to its implementation at home. In addition, the study aimed to analyze potential associations between usability measures and OAs’ performance during gameplay and assessments (eg, total exergame scores and reaction time), demographics, and training-related motivational factors. | PMC10739244 | |
Methods | PMC10739244 | |||
Materials | The COCARE system as an exergame-based telerehabilitation tool consists of four subsystems: (1) Dividat Senso (The assessment system allows for a comprehensive analysis of a user’s functional status to generate training recommendations. A report on the assessment results is delivered directly to the HPs and to OAs (for the latter, see Dividat Senso (left) and Senso Flex (right). Informed consent was obtained from the individuals in the picture allowing for the use of the picture for publication.Training overview and management in the rehabilitation cockpit.Example assessment report. | PMC10739244 | ||
Study Design | This usability study was conducted as a cross-sectional study at 3 study sites (ETH Zürich, Switzerland; Materia Group, Cyprus; and Istituto di Ricovero e Cura a Carattere Scientifico, Fondazione Don Carlo Gnocchi, Italy) using a mixed methods design (ie, qualitative [think-aloud method and open questions] and quantitative [questionnaires, game performance, and assessment results] data were collected). We followed the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) checklist [ | PMC10739244 | ||
Ethics Approval | The Ethics Commission of ETH Zürich (EK 2021-N-183); the Ethical Committee of Istituto di Ricovero e Cura a Carattere Scientifico, Fondazione Don Carlo Gnocchi, Milan (ID 05_09/12/2021); and Cyprus National Bioethics Committee (ΕΕΒΚ/ΕΠ/2021/51) examined and approved the study confirming that it complies with the principles of the Helsinki Declaration. | PMC10739244 | ||
Participants | psychiatric | RECRUITMENT, RECRUITMENT | We aimed to recruit 20 participants (15 OAs and 5 HPs) at each site, with a total sample size of 60 participants. To determine sample sizes, we considered studies recommending 3 to 5 [The inclusion criteria for OAs were (1) age of ≥60 years, (2) being community dwelling, and (3) being physically able to independently stand for at least 2 minutes. The exclusion criteria for OAs were (1) sensory impairments interfering with the use of the system, (2) a Mini-Mental State Examination (MMSE) score of <20, (3) terminal illnesses, and (4) previous or current major psychiatric illnesses. HPs were required to be actively involved in conducting physical or cognitive therapy sessions with older people as part of their workplace role and be registered and accredited members of the health care community.The recruitment methods in Switzerland included contacting older participants from previous studies of the Motor Control and Learning Group at ETH who had consented to be listed as potential future participants and using ongoing research collaborations with the VAMED rehabilitation center in Dussnang (Switzerland) to recruit HPs. In Cyprus and Italy, participants were recruited via convenience sampling—in Italy of patients usually attending the Fondazione Don Carlo Gnocchi clinics. Potentially eligible OAs and HPs were contacted and informed comprehensively about the study by phone or by handing out or sending flyers, as well as through detailed information sheets.Recruitment began in January 2022 and continued throughout the trial period, lasting from early February 2022 to late March 2022. | PMC10739244 |
Study Procedure | Each participant underwent a single assessment session lasting approximately 90 minutes. During this session, the COCARE system components were presented to participants, who subsequently tried them out. Each session at each site followed a standardized protocol corresponding to the natural flow of the COCARE system.First, the participant’s functional status was assessed using 2 tests on the Senso, beginning each test with a brief warm-up for familiarization before proceeding with the main assessment.The first assessment, the Stroop Test, is based on the Color-Word Interference Test by Stroop [Color part: squares in 4 different colors are displayed in the middle, and the color of the square has to be matched with the color of the respective circle.Word part: the given stimuli are the 4 different colors written in black. The written color has to be matched with the respective circle.Inhibition part: words are written in colors (red, green, blue, and yellow). The color of the writing has to be matched with the circles.Flexibility part: colored words appear in the center. Participants have to switch between selecting the color of the writing and the color they read in case the word is enclosed within a box.The second assessment, the Coordinated Stability Test originally developed by Lord et al [HPs performed both assessments twice—first assuming the role of a patient and then acting as a therapist guiding the investigator, who simulated the role of a patient.Subsequently, the investigators demonstrated the newly adapted UI of the assessment system, which participants had the opportunity to try out. Following this, an example assessment report describing and explaining the participants’ functional status and providing derived training recommendations was presented to all participants.Afterward, participants were instructed by the investigator to set up the Senso Flex before they engaged in a selection of predetermined exergames on the Senso Flex for 80 to 150 seconds each. The games included the following:Targets (divided attention and action planning; 80 s): balls come flying simultaneously from different directions and need to be hit when reaching the middle of 1 of 4 targets displayed on the screen by stepping in the corresponding direction.Tetris (action planning, visuospatial orientation, and mental rotation; 150 s): differently shaped pieces descending from the top to the bottom have to be rotated and moved to create complete horizontal lines.Rocket (endurance; 80 s): participants control a rocket flying through space by marching on the middle plate. A green arrow and a red bar indicate the need to increase or decrease stepping frequency, respectively.Evolve (balance control, weight shifting, and action planning; 80 s): blue rings, red dots, and a yellow figure are displayed on the screen. Participants control the yellow figure by shifting their center of pressure to catch the blue rings while avoiding the red dots.Simon (short-term memory and memory span; 80 s): a given stepping sequence must be memorized and repeated.Finally, participants were introduced to the COCARE rehabilitation cockpit, which involved the following two components:A training overview for HPs to monitor adherence displaying the user’s training frequency, components, and performance (The management system, which enables HPs to create a training plan by selecting appropriate games and setting training parameters for each game, such as duration, speed, and other game-specific setting options (Participants were also informed about the concept of a communication tool integrated into the COCARE system, and their wishes and expectations regarding such a tool were elicited.Before concluding the session, participants completed questionnaires addressing various aspects of usability, acceptance, and enjoyment.The 4 levels of the Stroop Test (from top left to bottom right).Output of the Coordinated Stability Test. | PMC10739244 | ||
Outcome and Outcome Measures in OAs | PMC10739244 | |||
Primary Outcomes | PMC10739244 | |||
Usability | Usability was assessed quantitatively using the System Usability Scale (SUS) [For the qualitative analysis of usability, a usability protocol was created consisting of 5 categories (Dividat Senso, assessment system, Dividat Senso Flex, exergames, and rehabilitation cockpit) that incorporated observations by the investigators and feedback from the participants. Participants were prompted to “think aloud” [ | PMC10739244 | ||
Acceptance | Adopting the definition of Peek et al [ | PMC10739244 | ||
Enjoyment | Enjoyment was measured using the Exergame Enjoyment Questionnaire (EEQ) [ | PMC10739244 | ||
Perceived Safety | dizziness, pain | The analysis of safety involved questions about dizziness or pain experienced during training. Moreover, critical moments such as tripping, slipping, swaying, or fear of falling were noted in the observation protocol. | PMC10739244 | |
Secondary Outcomes: Performance Parameters | One performance parameter for each exergame and assessment stored in the rehabilitation cockpit was collected for further analysis. | PMC10739244 | ||
Contextual Factors | The following factors, previously suggested to be determinants of OAs’ perceived usability and acceptance of technological (training) devices [Demographics (age, sex, and years of education)Training motivation, assessed using the Behavioral Regulation in Exercise Questionnaire–3 (BREQ-3) [ | PMC10739244 | ||
Outcomes and Outcome Measures in HPs | The outcomes and outcome measures for HPs were similar to those for OAs, with only slightly differing questions. While questions for OAs focused particularly on the comprehensibility of all components, HPs were also asked about their acceptance of the system as part of their therapies. Furthermore, exergame enjoyment, performance measures, and training motivation were omitted as they do not significantly contribute to the system’s usability from a therapist’s perspective. | PMC10739244 | ||
Statistical Analysis | SECONDARY | Potential differences in demographics between the different trial sites were tested using a 1-way ANOVA for continuous variables and a chi-square test for dichotomous variables.To quantitatively assess usability, descriptive statistics were generated for all quantitative data resulting from the primary outcomes (SUS, self-made usability questionnaire, UTAUT questionnaire, and EEQ), secondary outcome measures (assessment and performance measures), and contextual factors (demographic factors and BREQ-3).A bivariate correlation analysis among quantitative usability outcome measures (SUS, UTAUT questionnaire, and EEQ) and secondary as well as contextual factors was conducted using the Spearman correlation coefficient. The level of significance was set at α≤.05 (2-sided). Effect sizes were interpreted as small (All quantitative statistical analyses were performed using SPSS (version 26; IBM Corp). | PMC10739244 | |
Results | PMC10739244 | |||
Primary End Users (OAs) | PMC10739244 | |||
System Usability (OAs) | The overall SUS score was 68.1 (SD 18.8; n=45) and fell below the predefined 70-point score considered acceptable. When considering the individual countries, the scores differed, revealing acceptable usability in Switzerland (mean 81.5, SD 13.0), borderline acceptable usability in Cyprus (mean 69.3, SD 15.2), and unacceptable usability in Italy (mean 53.5, SD 17.0). | PMC10739244 | ||
Enjoyment (OAs) | Overall, participants from all 3 trial sites rated the enjoyment of playing the exergames with a mean score of 73.3 (SD 12.7) out of 100 points (range 34-96). Across the sites, participants in Switzerland reported the highest enjoyment (mean 82.8, SD 8.7), followed by Cyprus (mean 72.8, SD 8.4), whereas participants from Italy expressed the lowest average enjoyment (mean 63.5, SD 13.1). | PMC10739244 | ||
Safety (OAs) | dizziness, ’ desire, pain | Most older participants (38/45, 84%) indicated no fear of falling while playing the exergames on the Senso Flex. In terms of safety measures, most participants reported no pain (38/45, 84%) or dizziness (41/45, 91%). Although some participants experienced moments of struggling to maintain balance during the assessments or while playing the exergames, no falls occurred, and the handrail or other forms of lateral support sufficiently satisfied the participants’ desire for safety. | PMC10739244 | |
Perceived Usability of Single Components of the COCARE System (OAs) | The following results are based on the self-constructed questionnaire addressing various usability-related topics for each component of the COCARE system. | PMC10739244 | ||
Assessment System | The perceived usability of the assessments and the assessment report was evaluated very positively, with only 4% (2/45; question 2) to 16% (7/45; question 1) of neutral or negative ratings (Usability of (A) the assessment system, (B) the rehabilitation cockpit, and (C) the Senso Flex evaluated by older adults. | PMC10739244 | ||
Rehabilitation Cockpit | The rehabilitation cockpit also received positive ratings (As the rehabilitation cockpit is also intended to serve as a communication tool for HPs to provide training guidance, the concept of such a communication tool was explained to the participants, and they were further asked about their preferences regarding such a communication system. Among the participants, 58% (26/45) expressed a preference for receiving messages directly on the system, whereas others preferred to communicate via telephone (12/45, 27%), mail (5/45, 11%), or video call (18/45, 40%; multiple answers were possible). Most would like to communicate with HPs once a week (19/45, 42%) or every 2 weeks (10/45, 22%), and only 16% (7/45) would prefer more frequent contact. Concerning messages transmitted through the system, most participants (34/45, 76%) found it important to receive training recommendations, 40% (18/45) expressed interest in also receiving training motivations, and 33% (15/45) expressed interest in receiving training reminders. According to most participants (31/45, 69%), these messages should ideally be sent after training, whereas 49% (22/45) of participants would like to receive messages right before, and only 33% (15/45) during training (multiple answers were possible). | PMC10739244 | ||
Senso Flex and Exergames | The Senso Flex obtained mixed evaluations. Most participants (37/45, 82%) did not perceive any of the setup steps as difficult. Only a small number of participants experienced difficulties when unrolling the mat (1/45, 2%), connecting the mat to the computer (3/45, 7%), turning on the mat (2/45, 4%), turning on the computer (2/45, 4%), and when starting the games (6/45, 13%). On average, the older participants did not report any problems with navigation, understood the purpose of the exergames, and expressed satisfaction with both the physical and cognitive demands posed by the exergames ( | PMC10739244 | ||
Secondary Outcomes (OAs) | PMC10739244 | |||
Secondary End Users (HPs) | PMC10739244 | |||
System Usability (HPs) | The overall SUS score for HPs was 70.7 (SD 12.3; n=15), slightly surpassing the predefined acceptable threshold of 70 points. However, looking at site differences, participants from Cyprus and Italy rated the system with mean scores of 65.5 (SD 9.42) and 65.5 (SD 6.47) points, respectively, whereas in Switzerland, this score was significantly higher (mean 81.0, SD 13.99 points). | PMC10739244 | ||
Safety (HPs) | The issue of safety for OAs when training independently using the Senso Flex sparked disagreements among HPs. A total of 33% (5/15) of HPs considered independent use safe, whereas 47% (7/15) remained uncertain and 20% (3/15) even perceived a significant lack of safety. The primary concern raised by HPs was the absence of a handrail, which they felt should be available, especially for OAs with a fear of falling or those with certain medical conditions. | PMC10739244 | ||
Usability of Single Components of the COCARE System (HPs) | PMC10739244 | |||
Assessment System | Overall, HPs provided favorable ratings for the assessment system (Usability of (A) the assessment system, (B) the rehabilitation cockpit, and (C) the Senso Flex evaluated by health care professionals. OA: older adult. | PMC10739244 | ||
Rehabilitation Cockpit | The rehabilitation cockpit received positive evaluations (In terms of future ways of communicating with their patients, most HPs would find it useful to send training reminders (14/15, 93%), motivational messages (13/15, 87%), and training feedback. A total of 87% (13/15) of HPs regarded messages on the system as a favorable option, and more than half (8/15, 53%) of HPs would like to have video calls as well. In contrast, communicating via telephone was perceived as less appealing, and similarly, only 7% (1/15) of the participants considered sending emails a suitable means of communication. | PMC10739244 | ||
Senso Flex and Exergames | Questions related to the Senso Flex primarily concerned its setup and navigation through the games. A total of 20% (3/15) of the participants would not expect any difficulties with any setup step. However, most HPs (9/15, 60%) found it challenging to connect the Senso Flex to the computer, unroll the mat (1/15, 7%), turn on the mat (5/15, 33%), turn on the computer (5/15, 33%), and start the games (6/15, 40%). Consequently, most HPs (9/15, 60%) believed that external support or a caregiver would be necessary.Regarding an exergame-based training on the Senso Flex, opinions were positive ( | PMC10739244 | ||
Summary of the Usability Protocol (HPs) | HPs did not share many opinions or suggestions for further development of the Senso but focused more on the other components of the COCARE system. Regarding the assessment system, they found the UI and navigation easy and user-friendly, praising the warm-up feature as well as the possibility of repeating the warm-up as often as needed. However, they were more critical of the Stroop Test, questioning its feasibility and comprehensibility. In addition, some HPs felt that the Coordinated Stability Test could be too demanding for OAs.Regarding the assessment report, HPs appreciated the general structure and training recommendations; they only wished for simpler explanations of specific terms such as HPs’ criticisms of the Senso Flex aligned with the OAs’ requirements. For instance, the low step detection sensitivity of the mat and lack of demarcation of the center area were common concerns shared by HPs and OAs. In this regard, it was suggested to create an embossed border or tactile texture separating the center area from the outer fields. Finally, a few HPs expressed concerns about the risk of falling, which is why they proposed providing lateral support through chairs or walkers.The exergames were viewed very positively by HPs, who found them to be a good challenge, good exercise, and enjoyable. In addition, most HPs described the instructions as understandable and intuitive. Only some suggested the inclusion of pictures or animations to illustrate the instructions. When evaluating the games separately, Finally, when commenting on the rehabilitation cockpit, HPs particularly praised its overall usefulness and the clear overview of training progress. Furthermore, they found the general UI and especially the setting possibilities to be simple and intuitive. Nevertheless, a few HPs rated other therapists’ and older patients’ acceptance of remote therapy and constant monitoring as low. Moreover, HPs suggested some improvements regarding future communication possibilities, namely, the integration of a video call feature, a chat section, or a real-time audio-video connection.In | PMC10739244 | ||
Discussion | PMC10739244 | |||
Overview | SECONDARY | This study aimed to investigate the usability of the newly developed exergame-based COCARE system for telerehabilitation in OAs. Usability was assessed quantitatively and qualitatively, and valuable insights into the perspectives of OAs and HPs regarding the COCARE system was gained. Overall usability, enjoyment, acceptance, and safety ratings were acceptable. The analysis revealed that some parts of the system need improvement—especially regarding comprehensibility of assessments and game instructions and hardware features. Almost all secondary outcomes showed manifold correlations with the usability outcomes. Each of these outcomes will be discussed in the following sections. | PMC10739244 | |
Overall Usability | SD | The overall usability of the system, quantitatively assessed using the SUS, was rated with a mean score of 68.1 (SD 18.8; OAs) and 70.7 (SD 12.3; HPs) points. A score of 70 points has been defined as “fully acceptable” [It is worth noting that usability scores from previous studies on similar exergame systems vary, with some studies showing slightly higher [In contrast, Thalmann et al [ | PMC10739244 | |
Usability of the Single Components of the COCARE System | PMC10739244 | |||
Assessment System | The assessment system received positive ratings in the questionnaire from both OAs and HPs. However, when asked to think aloud, participants indicated difficulties in understanding the instructions provided by the system, suggesting the integration of videos or pictures to visualize the instructions. These evaluations indicate the importance of a well-structured system, starting with easy assessments before moving on—and only if necessary—to more advanced assessments. | PMC10739244 | ||
Senso Flex | Concerning the Senso Flex, a crucial aspect for OAs is its setup demands. Observations made by the investigators and the perceived level of difficulty reported by the OAs indicated that, on average, the older participants performed very well in setting up the system. However, it became evident that HPs significantly underestimated OAs’ ability to properly set up and operate the Senso Flex. Similarly, HPs expressed concerns about the risk of falls when OAs train independently using the Senso Flex—a concern not shared by most OAs themselves. Both discrepancies were previously observed in the first study (focus group study) of the COCARE project [Nevertheless, participants in Switzerland and Italy repeatedly reported sensitivity issues with the Senso Flex, resulting in incorrect step detection. In addition, participants from both groups at all sites criticized specific hardware and software issues, namely, missing handrails, problems with internet connection, and orientation difficulties on the mat because of insufficient visual or tactile demarcations of the fields. All these issues, along with technological malfunctions, likely had a substantial impact on the deduction of SUS scores. Consequently, in the further evolution of the COCARE system, resolving these software and hardware problems is crucial to enhance its usability and acceptance. | PMC10739244 | ||
Exergames | Despite encountering several difficulties, both OAs and HPs expressed overall satisfaction with the exergames as they recognized the potential physical and cognitive benefits of the exergame training and awarded high exergame enjoyment scores. This is in line with previous literature, which indicates that exergames are accepted by and usable for healthy OAs [ | PMC10739244 | ||
Rehabilitation Cockpit and Telerehabilitation | DISEASES | The rehabilitation cockpit, serving as a tool for telerehabilitation, garnered positive feedback from both OAs and HPs. Participants found it highly useful and interesting for patients as well as for HPs. These observations are in accordance with previous research, which highlighted that OAs recognize the value of mobile health—a form of telerehabilitation. Specifically, mobile health and telemedicine have been found to be effective, for instance, in treating noncommunicable diseases [However, previous studies have also identified common barriers to adherence and effectiveness of telerehabilitation. These include, for instance, technological literacy, internet access, usability, education, social support, perceived need, and costs [Surprisingly, and contrary to other studies [ | PMC10739244 | |
Enjoyment | The average EEQ scores point to a satisfying enjoyment of the exergames—a result supported by the qualitative analyses of satisfaction with the exergames. Manser et al [Drawing on this assumption, Sweetser and Wyeth [ | PMC10739244 | ||
Acceptance | The overall acceptance ratings based on the UTAUT were high among both OAs and HPs. These findings align with those of Baschung Pfister et al [Analyzing the UTAUT subcategories, Surprisingly, | PMC10739244 | ||
Safety | dizziness, pain | ADVERSE EVENTS | Despite momentary balance issues in a few participants, most OAs did not report fear of falling when using the Senso Flex, and only a small number of participants experienced pain or dizziness while playing the exergames, with no adverse events. This aligns with a review conducted by Valenzuela et al [ | PMC10739244 |
Influencing Factors | SECONDARY, DISORDERS | The secondary aim of this study was to analyze possible correlations among potential influencing factors, namely, age, sex, years of education, training motivation, game and assessment performance, and measures of usability. Except for sex and years of education, many significant correlations were found, with the SUS exhibiting the highest number of associations with all secondary outcome measures—most likely because of its comprehensive assessment of overall usability covering all other measures of usability. Concerning sex and years of education, the results of previous studies are controversial [Regarding training motivation and performance measures, the direction of the effects must be further evaluated. Possibly, a highly usable device fosters higher motivation and better performance, but conversely, motivated individuals or those performing well in the games may perceive the system as more usable than others.Moreover, it must be considered that the differences in performance, acceptance, and usability ratings were primarily attributed to the participants’ country affiliation, with participants from Switzerland showing the best performance and giving the highest usability and acceptance ratings, whereas those in Italy generally exhibited much lower values in all outcome measures. Possible explanations for this disparity include the fact that participants recruited in Italy had a higher, though not statistically relevant, mean age and had various disorders, in contrast to participants enrolled in Switzerland and Cyprus, who were physically and mentally healthy. In addition, cultural and family structure differences may have played a role as people in Italy and Cyprus tend to live in larger families with stronger bonds compared with Northern European countries and their “contemporary Western lifestyle” [ | PMC10739244 | |
Strength and Limitations | The strength of this study is that (contrary to previous usability studies) it not only directly compares the opinions and demands of HPs and OAs but also provides valuable insights into country- and culture-related differences within both participant groups. Moreover, this study points to future pathways for developing feasible, user-friendly, and enjoyable exergame systems tailored for home settings.A major limitation of this study is that the system could only be tried out once, mainly because of COVID-19 restrictions. Nevertheless, the participants’ feedback indicated that they were able to immerse themselves in the exergame experience and that their expressed opinions were not solely based on their one-time gaming session but also took potential long-term use into account. Future feasibility trials will provide deeper insights into the usability and acceptance of the COCARE system when used over a longer period. | PMC10739244 | ||
Conclusions | This study revealed some differences between OAs and HPs in terms of their perception of usability and acceptance of the COCARE system. OAs demonstrated higher acceptance of the system and better performance on the Senso and Senso Flex and found the setup of the Senso Flex to be easier than expected by most HPs. Furthermore, OAs were less concerned about the potential risk of falls compared with HPs.Disparities also emerged among the study sites concerning all usability and acceptance ratings, possibly stemming from cultural differences in the significance and proximity of family and the resulting motivation to integrate ICTs into everyday life.Several important requirements were identified by both OAs and HPs, which should be considered in further development efforts to enhance the usability of these and other technology-based telerehabilitation training systems. These include improvements in mat sensitivity, markings on the mat for a better orientation, stable internet connection, simplification of the instructions and results presentation for some assessments, adaptation of some games and their instructions (eg, video instructions) to be more usable and enjoyable for OAs (especially This work was funded by the European Union and the national funding authorities involved (Innosuisse [the Swiss Innovation Agency], the Italian Ministry of Health, and the Cyprus Research and Innovation Foundation) as part of the AAL Joint Program under grant aal-2020-7-145-CP. Open-access funding was provided by ETH Zürich. The authors did not use the generative artificial intelligence (AI) tool ChatGPT or other generative AI tools in any portion of the manuscript.Authors' Contributions: JS was responsible for conceptualization, methodology, data curation, formal analysis, and writing—original draft, whereas EG contributed to conceptualization, methodology, supervision, and writing—original draft. EDdB was responsible for methodology and cosupervision. ES, FR, IC, MF, SM, and TR contributed to methodology, data curation, and writing—review and editing. All authors revised the manuscript and approved the version submitted for publication, and they agree to be accountable for all aspects of the work.Conflicts of Interest: EDdB was a cofounder of Dividat, the spin-off company that created and developed the Continuum-of-Care system used in this study. However, no revenue was paid (or promised to be paid) directly to EDdB or his institution. SM was employed by the company Materia Group. The remaining authors declare no conflicts of interest.STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) checklist.Usability protocol: comments, questions, and observations by older adults and the investigator.Performance of older adults in games and assessments.Usability protocol: comments, questions, and observations by health care professionals and the investigator. | PMC10739244 | ||
Abbreviations | Behavioral Regulation in Exercise Questionnaire–3Continuum-of-CareExergame Enjoyment Questionnairehealth care professionalinformation and communications technologyMini-Mental State Examinationolder adultStrengthening the Reporting of Observational Studies in EpidemiologySystem Usability ScaleTechnology Acceptance Modeluser-centered designuser interfaceUnified Theory of Acceptance and Use of Technology | PMC10739244 | ||
Data Availability | The raw data supporting the conclusions of this study will be made available by the authors without undue reservation to any qualified researcher upon request. | PMC10739244 | ||
Subject terms | multiple myeloma | MULTIPLE MYELOMA | Patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem cell transplantation (ASCT) have lower survival rates and may benefit from frontline regimens that include novel agents. This Phase 1b study (NCT02513186) evaluated preliminary efficacy, safety, and pharmacokinetics (PK) of isatuximab, an anti-CD38 monoclonal antibody, combined with bortezomib-lenalidomide-dexamethasone (Isa-VRd) in patients with NDMM ineligible for/with no intent for immediate ASCT. Overall, 73 patients received four 6-week induction cycles of Isa-VRd, then maintenance with Isa-Rd in 4-week cycles. In the efficacy population ( | PMC10264885 |
Introduction | transplant-ineligible, tumor | DISEASE PROGRESSION, MULTIPLE MYELOMA (MM), TUMOR | Despite treatment advances contributing to improved outcomes in patients with multiple myeloma (MM), those not eligible for autologous stem cell transplantation (ASCT) have lower survival rates partially due to receiving less-intensive therapy based on advanced age and/or comorbidities [Molecular and immunophenotypic techniques can be used to monitor MRD [Bortezomib-lenalidomide-dexamethasone (VRd) has become a standard-of-care regimen in patients with NDMM ineligible for/with no intent for immediate ASCT based on the Phase 3 SWOG S0777 study, in which VRd administered until disease progression resulted in significantly longer OS than with lenalidomide-dexamethasone (Rd) alone [Adding anti-CD38 monoclonal antibodies (eg, isatuximab) to the VRd standard-of-care regimen may provide additional options for patients. Isatuximab, an IgG1 monoclonal antibody that targets a specific epitope of CD38, has multiple tumor cell–killing mechanisms of action [This study was designed to evaluate the preliminary efficacy, safety, and pharmacokinetics of the quadruplet regimen of isatuximab combined with VRd (Isa-VRd) in transplant-ineligible patients with NDMM. In the Isa-VRd Part B cohort, patients with no intent for immediate transplant were also included. | PMC10264885 |
Methods | PMC10264885 | |||
Study design | MM | ONCOLOGY, MAY, RECRUITMENT | This open-label, multicenter, Phase 1b study enrolled adults with measurable NDMM ineligible for (Part A and B) or without intent for (Part B) immediate transplantation. Patients with ultra-high–risk smoldering MM fulfilling IMWG criteria were also eligible. Patients were excluded if they had an Eastern Cooperative Oncology Group performance status >2, inadequate liver or renal function, major surgery or radiation therapy within 14 days before study treatment administration, or prior systemic curative treatment for MM. The recruitment periods were May 4, 2017 – April 20, 2018 (Part A) and March 29, 2019 – January 27, 2020 (Part B). The study was conducted in accordance with consensus ethics principles derived from international ethics guidelines, including the Declaration of Helsinki, the International Council for Harmonisation guidelines for Good Clinical Practice, and all applicable laws, rules, and regulations. Written informed consent was obtained prior to conducting any study-related procedures. The study design is shown in Fig. | PMC10264885 |
Treatments | toxicity | DISEASE PROGRESSION | Isa-VRd was administered for four 6-week cycles during the induction phase, followed by Isa-Rd (maintenance) until disease progression, unacceptable toxicity, or patient withdrawal. Based on previous findings in relapsed/refractory MM [ | PMC10264885 |
Assessments | Cancer | ADVERSE EVENT, T(4;14), EVENTS, DISEASE, T(14;16), CANCER | Disease assessments were performed by investigators every cycle based on local laboratory for serum, urine M-protein, and free light chain (FLC) parameters using IMWG criteria [For patients with suspected isatuximab interference on serum immunofixation (IFE), the Sebia HYDRASHIFT 2/4 Isatuximab IFE test was used by the central laboratory to specifically measure endogenous M-protein. The adjusted response defined the final CR rate per IMWG criteria.High-risk cytogenetic status was determined based on the presence of del17p, t(4;14), t(14;16), and 1q21+ by both local and central fluorescence in situ hybridization assessments.MRD was assessed by NGF and NGS at 10Adverse events (AEs) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. | PMC10264885 |
Pharmacokinetics | BLOOD | Blood samples were collected at predetermined time points. Isatuximab plasma concentrations were determined with a validated ELISA method (lower limit of quantification, 0.500 ng/mL). Lenalidomide and bortezomib plasma concentrations were determined using validated LC-MS/MS methods (lower limits of quantification, 1.00 ng/mL and 0.500 ng/mL, respectively). PK parameters were calculated based on a non-compartmental analysis (NCA) from the isatuximab, bortezomib, and lenalidomide plasma concentrations obtained after the first and repeated administrations. | PMC10264885 | |
Immunophenotyping | BLOOD | Blood samples were taken at Day 1 of Cycles 1 and 3, and at the end of treatment to explore microenvironment changes. Immune cell populations (ie, CD3, CD4, and CD8 T cell, and NK-cell subsets) were characterized by multiparametric flow cytometry analysis for cell surface marker expression. | PMC10264885 | |
Statistical analysis | For Part A, Simon’s two-stage optimal design was used to determine the sample size. The null hypothesis that the true confirmed CR response rate is 16% was tested against a one-sided alternative. In the first stage, 13 patients were treated. If there were ≤2 confirmed CR response in these 13 patients, the study was to be stopped. Otherwise, 13 additional patients would be treated for a total of 26. The null hypothesis was to be rejected if ≥7 confirmed CR responses were observed in 26 patients. This design yields a Type I error rate of 0.10 and power of 0.80 when the true response rate is 35%.For Part B, a single-stage, fixed design was used. A total of 44 patients was calculated to provide ≥90% power to reject the null hypothesis that the true response rate is ≤16% when the true response rate is ≥35%, based on a one-sided binomial test with a significance level of 0.05. The null hypothesis was to be rejected if the observed CR rate is ≥25% (11 patients with CR).Unless otherwise specified, safety analyses were descriptive and performed using the all-treated population. Efficacy endpoints were analyzed using the efficacy population. DOR, PFS, and OS were analyzed using the Kaplan-Meier method.See Supplementary Materials for additional methods details. | PMC10264885 | ||
Results | PMC10264885 | |||
Patient disposition | Of the 27 patients treated in Part A, 13 discontinued treatment due to AEs ( | PMC10264885 | ||
Infusion duration | In Part A, median duration for the first infusion was 3 h 44 min for patients receiving the weight-based infusion and 3 h 25 min for patients who switched to the fixed-volume infusion method. The median duration decreased to 2 h 49 min and 1 h 48 min for the second infusion, 2 h 45 min and 1 h 18 min for the third infusion, and 2 h 35 min and 1 h 18 min for subsequent infusions.In Part B, with the fixed-volume infusion method, the median duration of infusion decreased from 3 h 41 min for the first infusion to 1 h 55 min for the second infusion, 1 h 17 min for the third infusion, and 1 h 20 min for subsequent infusions. | PMC10264885 | ||
Stem cell mobilization (Part B) | In Part B, 13 (28.3%) patients were eligible but without immediate intent for ASCT and 7 (53.8%) proceeded to stem cell mobilization. Overall, 4 (30.8%) patients proceeded with ASCT: 3 discontinued study treatment to have immediate ASCT per protocol and 1 decided to discontinue study treatment (due to heavy study procedure) and had ASCT during follow-up. Additional details are in the Supplementary Materials. | PMC10264885 | ||
Best overall response (BOR) | For the 71 patients in Parts A and B comprising the efficacy population, the ORR was 98.6% ( | PMC10264885 | ||
Minimal residual disease | BOR | MRD status was assessed in patients with VGPR or better as BOR. In the efficacy-evaluable population, 36/71 (50.7%) patients achieved MRD- (sensitivity 10 | PMC10264885 |
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