Introducing the Dysphagiameter: a novel patient-reported outcome measure for evaluating dysphagia in oculopharyngeal muscular dystrophy - from conceptual framework to initial development.

Oculopharyngeal muscular dystrophy (OPMD) is a rare late-onset muscle disease associated with progressive dysphagia. As there was no patient-reported outcome measure specific for the assessment of dysphagia in OPMD, the Dysphagiameter was developed. The Food and Drug Administration guidance was followed. In Phase 1, a systematic literature review and an expert consultation were conducted to identify the concepts of interest. It was decided that the instrument should assess difficulty swallowing using pictures of foods of various textures (part A) and impact of dysphagia on activities and participation (part B), as defined by the International Classification of Functioning, Disability and Health. In Phase 2, focus groups (n = 3) and online surveys (n = 55) were conducted to generate the items. Then, the food items for part A were selected and grouped into 17 textures by a panel of registered dietitians. Cognitive interviews were conducted (n = 23) to refine the instrument and assess its clarity and comprehensiveness. The final draft included 82 food items assessing the capacity to swallow foods and drinks (part A) and 10 items assessing the impact of dysphagia on activities and participation (part B). Item reduction and assessment of psychometrics properties, using Rasch analysis, are ongoing as part of Phase 3.

Sexual Rehabilitation After a Stroke: A Multi-site Qualitative Study About Influencing Factors and Strategies to Improve Services.

This study aimed to better understand the factors influencing the provision of sexuality-related post-stroke rehabilitation services by clinicians on different sites and to explore strategies to improve post-stroke rehabilitation services with stakeholders. A qualitative study with co-design methods was conducted with 20 clinicians from five post-stroke rehabilitation centers in Canada, 1 manager and 1 patient-partner. Participants either took part in a focus group or in sessions of an adapted version of the LEGO Serious Play method to explore influencing factors and strategies of improvement in relation to post-stroke sexual rehabilitation services. Thematic analysis was conducted semi-deductively using the Theoretical Domains Framework (TDF), the Capability, Opportunity, Motivation and Behaviour (COM-B) system and the Behaviour Change Wheel (BCW). A total of twenty factors pertaining either to the categories of Capability (n = 8; e.g., Sexual rehabilitation procedural knowledge), Motivation (n = 4; e.g., Professional boundaries) or Opportunity (n = 8; e.g., Workload) were perceived as influencing provision of sexual rehabilitation services by participants. A theoretical model was conceptualized. Strategies (n = 10) were categorized in concordance with the BCW as Training (n = 1), Enablement (n = 5) or Environmental restructuring (n = 4). This study showed that factors influencing provision of post-stroke rehabilitation services were numerous and interrelated, and that various strategies aiming either clinicians or the rehabilitation environment would be relevant to improve services. This study will help guide the design and implementation of future interventions studies aiming at improving post-stroke sexual rehabilitation services.

Co-designing a Program to Improve Post-stroke Sexual Rehabilitation: The Promise of Innovative Methods.

Introduction: Most people who sustain a stroke are likely to experience sexual difficulties during their recovery. However, few people get the opportunity to address sexuality during their rehabilitation because of factors related to the organization (e.g., culture), managers (e.g., lack of resources), clinicians (e.g., perceived lack of knowledge, skills, and comfort), and clients (e.g., taboo). A multifactorial program tailored to stakeholders' needs with various complementary interventions is needed to lead to a change of practice in post-stroke sexual rehabilitation. Objective: To co-design with stakeholders (i.e., people with stroke, partners, clinicians, managers and researchers) a theory-driven multifactorial program to improve post-stroke sexual rehabilitation services. Methods: This qualitative study will be conducted in four steps using an Intervention Mapping approach and a co-design methodology divided into four phases: (1) exploration; (2) co-design; (3) validation; and (4) development. Persons with stroke, partners, clinicians and managers from five distinct stroke rehabilitation centres in the province of Quebec (Canada), and researchers will be recruited to either participate in an advisory committee or working groups throughout the study. A combination of contributions from three different types of groups (advisory group, Lego® groups, work groups) will be used for data collection. Qualitative data analysis will first be realized by two independent reviewers using the Theoretical Domains Framework, and preliminary results of analysis will be validated with the advisory and working groups. Conclusion: This study will lead to the co-design of the first theory-driven program intended to optimize post-stroke sexual rehabilitation services.

Lessons Learned From Clinicians and Stroke Survivors About Using Telerehabilitation Combined With Exergames: Multiple Case Study.

BACKGROUND: In Canada, stroke survivors have difficulty accessing community-based rehabilitation services because of a lack of resources. VirTele, a personalized remote rehabilitation program combining virtual reality exergames and telerehabilitation, was developed to provide stroke survivors an opportunity to pursue rehabilitation of their chronic upper extremity (UE) deficits at home while receiving ongoing follow-up from a clinician. OBJECTIVE: We aimed to identify the behavioral and motivational techniques used by clinicians during the VirTele intervention, explore the indicators of empowerment among stroke survivors, and investigate the determinants of VirTele use among stroke survivors and clinicians. METHODS: This multiple case study involved 3 stroke survivors with chronic UE deficits and their respective clinicians (physiotherapists) who participated in the VirTele intervention, a 2-month remote rehabilitation intervention that uses nonimmersive virtual reality exergames and telerehabilitation aimed at improving UE deficits in stroke survivors. Study participants had autonomous access to Jintronix exergames and were asked to use them for 30 minutes, 5 times a week. The VirTele intervention included 1-hour videoconference sessions with a clinician 1 to 3 times a week, during which the clinician engaged in motivational interviewing, supervised the stroke survivors' use of the exergames, and monitored their use of the affected UE through activities of daily living. Semidirected interviews were conducted with the clinicians and stroke survivors 4 to 5 weeks after the end of the VirTele intervention. All interviews were audiorecorded and transcribed verbatim. An abductive thematic analysis was conducted to generate new ideas through a dynamic interaction between data and theory. RESULTS: Three stroke survivors (n=2, 67%, women and n=1, 33%, man), with a mean age of 58.8 (SD 19.4) years, and 2 physiotherapists participated in the study. Five major determinants of VirTele use emerged from the qualitative analyses, namely technology performance (usefulness and perception of exergames), effort (ease of use), family support (encouragement), facilitators (considerations of the stroke survivors' safety as well as trust and understanding of instructions), and challenges (miscommunication and exergame limits). During the VirTele intervention, both clinicians used motivational and behavioral techniques to support autonomy, competence, and connectivity. All these attributes were reflected as empowerment indicators in the stroke survivors. Lessons learned from using telerehabilitation combined with exergames are provided, which will be relevant to other researchers and contexts. CONCLUSIONS: This multiple case study provides a first glimpse into the impact that motivational interviewing can have on adherence to exergames and changes in behavior in the use of the affected UE in stroke survivors. Lessons learned regarding the supportive role caregivers play and the new responsibilities clinicians have when using the VirTele intervention may inform the use of exergames via telerehabilitation. These lessons will also serve as a model to guide the implementation of similar interventions. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/14629.

Rehabilitation of Upper Extremity by Telerehabilitation Combined With Exergames in Survivors of Chronic Stroke: Preliminary Findings From a Feasibility Clinical Trial.

BACKGROUND: Exergames are increasingly being used among survivors of stroke with chronic upper extremity (UE) sequelae to continue exercising at home after discharge and maintain activity levels. The use of virtual reality exergames combined with a telerehabilitation app (VirTele) may be an interesting alternative to rehabilitate the UE sequelae in survivors of chronic stroke while allowing for ongoing monitoring with a clinician. OBJECTIVE: This study aimed to determine the feasibility of using VirTele in survivors of chronic stroke at home and explore the impact of VirTele on UE motor function, quantity and quality of use, quality of life, and motivation in survivors of chronic stroke compared with conventional therapy. METHODS: This study was a 2-arm feasibility clinical trial. Eligible participants were randomly allocated to an experimental group (receiving VirTele for 8 weeks) or a control group (receiving conventional therapy for 8 weeks). Feasibility was measured from the exergame and intervention logs completed by the clinician. Outcome measurements included the Fugl-Meyer Assessment-UE, Motor Activity Log-30, Stroke Impact Scale-16, and Treatment Self-Regulation Questionnaire-15, which were administered to both groups at four time points: time point 1 (T1; before starting the intervention), time point 2 (after the intervention), time point 3 (1 month after the intervention), and time point 4 (T4; 2 months after the intervention). RESULTS: A total of 11 survivors of stroke were randomized and allocated to an experimental or a control group. At the onset of the COVID-19 pandemic, participants pursued the allocated treatment for 3 months instead of 8 weeks. VirTele intervention dose was captured in terms of time spent on exergames, frequency of use of exergames, total number of successful repetitions, and frequency of videoconference sessions. Technical issues included the loss of passwords, internet issues, updates of the system, and problems with the avatar. Overall, most survivors of stroke found the technology easy to use and useful, except for 9% (1/11) of participants. For the Fugl-Meyer Assessment-UE and Motor Activity Log-30, both groups exhibited an improvement in >50% of the participants, which was maintained over time (from time point 3 to T4). Regarding Stroke Impact Scale-16 scores, the control group reported improvement in activities of daily life (3/5, 60%), hand function (5/5, 100%), and mobility (2/5, 40%), whereas the experimental group reported varied and inconclusive results (from T1 to T4). For the Treatment Self-Regulation Questionnaire-15, 75% (3/4) of the experimental group demonstrated an increase in the autonomous motivation score (from T1 to time point 2), whereas, in the control group, this improvement was observed in only 9% (1/11) of participants. CONCLUSIONS: The VirTele intervention constitutes another therapeutic alternative, in addition to conventional therapy, to deliver an intense personalized rehabilitation program for survivors of chronic stroke with UE sequelae. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/14629.

A Personalized Home-Based Rehabilitation Program Using Exergames Combined With a Telerehabilitation App in a Chronic Stroke Survivor: Mixed Methods Case Study.

BACKGROUND: In Canada, only 11% of stroke survivors have access to outpatient and community-based rehabilitation after discharge from inpatient rehabilitation. Hence, innovative community-based strategies are needed to provide adequate postrehabilitation services. The VirTele program, which combines virtual reality exergames and a telerehabilitation app, was developed to provide stroke survivors with residual upper extremity deficits, the opportunity to participate in a personalized home rehabilitation program. OBJECTIVE: This study aims to determine the feasibility of VirTele for remote upper extremity rehabilitation in a chronic stroke survivor; explore the preliminary efficacy of VirTele on upper extremity motor function, the amount and quality of upper extremity use, and impact on quality of life and motivation; and explore the determinants of behavioral intention and use behavior of VirTele along with indicators of empowerment. METHODS: A 63-year-old male stroke survivor (3 years) with moderate upper extremity impairment participated in a 2-month VirTele intervention. He was instructed to use exergames (5 games for upper extremity) for 30 minutes, 5 times per week, and conduct videoconference sessions with a clinician at least once per week. Motivational interviewing was incorporated into VirTele to empower the participant to continue exercising and use his upper extremities in everyday activities. Upper extremity motor function (Fugl-Meyer Assessment-upper extremity), amount and quality of upper extremity use (Motor Activity Log-30), and impact on quality of life (Stroke Impact Scale-16) and motivation (Treatment Self-Regulation Questionnaire-15) were measured before (T1), after (T2) VirTele intervention, and during a 1- (T3) and 2-month (T4) follow-up period. Qualitative data were collected through logs and semistructured interviews. Feasibility data (eg, number and duration of videoconference sessions and adherence) were documented at the end of each week. RESULTS: The participant completed 48 exergame sessions (33 hours) and 8 videoconference sessions. Results suggest that the VirTele intervention and the study protocol could be feasible for stroke survivors. The participant exhibited clinically meaningful improvements at T2 on the Fugl-Meyer and Stroke Impact Scale-16 and maintained these gains at T3 and T4. During the follow-up periods, the amount and quality of upper extremity use showed meaningful changes, suggesting more involvement of the affected upper extremity in daily activities. The participant demonstrated a high level of autonomous motivation, which may explain his adherence. Performance, effort, and social influence have meaningful weights in the behavioral intention of using VirTele. However, the lack of control of technical and organizational infrastructures may influence the long-term use of technology. At the end of the intervention, the participant demonstrated considerable empowerment at both the behavioral and capacity levels. CONCLUSIONS: VirTele was shown to be feasible for use in chronic stroke survivors for remote upper extremity rehabilitation. Meaningful determinants of behavioral intention and use behavior of VirTele were identified, and preliminary efficacy results are promising. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/14629.

Optimization of Upper Extremity Rehabilitation by Combining Telerehabilitation With an Exergame in People With Chronic Stroke: Protocol for a Mixed Methods Study.

BACKGROUND: Exergames have the potential to provide an accessible, remote approach for poststroke upper extremity (UE) rehabilitation. However, the use of exergames without any follow-up by a health professional could lead to compensatory movements during the exercises, inadequate choice of difficulty level, exercises not being completed, and lack of motivation to pursue exercise programs, thereby decreasing their benefits. Combining telerehabilitation with exergames could allow continuous adjustment of the exercises and monitoring of the participant's completion and adherence. At present, there is limited evidence regarding the feasibility or efficacy of combining telerehabilitation and exergames for stroke rehabilitation. OBJECTIVE: This study aims to (1) determine the preliminary efficacy of using telerehabilitation combined with exergames on UE motor recovery, function, quality of life, and motivation in participants with chronic stroke, compared with conventional therapy (the graded repetitive arm supplementary program; GRASP); (2) examine the feasibility of using the technology with participants diagnosed with stroke at home; and (3) identify the obstacles and facilitators for its use by participants diagnosed with stroke and stroke therapists and understand the shared decision-making process. METHODS: A mixed methods study protocol is proposed, including a randomized, blinded feasibility trial with an embedded multiple case study. The intervention consists of the provision of a remote rehabilitation program, during which participants will use the Jintronix exergame for UE training and the Reacts Application to conduct videoconferenced sessions with the therapists (physical or occupational therapists). We plan to recruit 52 participants diagnosed with stroke, randomly assigned to a control group (n=26; 2-month on-paper home exercise program: the GRASP with no supervision) and an experimental group (n=26; 2-month home program using the technology). The primary outcome is the Fugl-Meyer UE Assessment, a performance-based measure of UE impairment. The secondary outcomes are self-reported questionnaires and include the Motor Activity Log-28 (quality and frequency of use of the UE), Stroke Impact Scale-16 (the quality of life), and Treatment Self-Regulation Questionnaire (motivation). Feasibility data include process, resources, management, and scientific outcomes. Qualitative data will be collected by interviews with both participants and therapists. RESULTS: At present, data collection was ongoing with one participant who had completed the exergame- telerehabilitation based intervention. We expect to collect preliminary efficacy data of this technology on the functional and motor recovery of the UE, following a stroke; collect feasibility data with users at home (adherence, safety, and technical difficulties); and identify the obstacles and facilitators for the technology use and understand the shared decision-making process. CONCLUSIONS: This paper describes the protocol underlying the study of a telerehabilitation-exergame technology to contribute to understanding its feasibility and preliminary efficacy for UE stroke rehabilitation. TRIAL REGISTRATION: ClinicalTrials.gov NCT03759106; http://clinicaltrials.gov/show/NCT03759106. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14629.