Stroke (6 Months or More After Onset)
Conditions
Keywords
Stroke, Hand function, Robotic exoskeleton, Virtual care, Rehabilitation, Neurological rehabilitation, Hand therapy
Brief summary
The goal of this clinical trial is to understand whether a program of using a hand robot at home, supported by telerehabilitation, is feasible for people living with stroke. The study aims to answer the following questions: * What is the extent that people living with stroke complete the prescribed therapy program? (adherence) * Do people living with stroke continue to participate in the therapy program until follow-up? (retention) * How acceptable and helpful is the hand robot to be use at the outpatient rehabilitation clinic and home via telerehabilitation for people living with stroke? * How reliable and safe is the hand robot when used in clinical and home settings? * What are the costs of delivering the hand robot program compared to providing the same amount of standard therapy without the hand robot? Researchers will also compare rehabilitation using the hand robot program to a dose-matched therapy program that does not use the robot. * Intervention group: Participants will use the hand robot for 12 weeks, with follow-up intervention and assessments at 6 months. * Control (comparator) group: Participants will receive the same amount of therapy over 12 weeks, but without the hand robot, followed by 6-month follow-up. For both groups, researchers will record information about each participant's clinical recovery, their experience with the therapy process and the cost of care.
Detailed description
The objective of this study is to examine the clinical, technical, and economic feasibility of the WEAR-IT program, a robotic glove-based telerehabilitation intervention, when delivered in outpatient rehabilitation clinics and home settings for individuals living with chronic hand function limitations following a stroke. This pilot, multi-site, single-blind (masked) feasibility study includes an embedded feasibility randomized controlled trial conducted at Sunnybrook - St. John's Rehab in Toronto and the Glenrose Rehabilitation Hospital in Edmonton, with a total sample of 44 persons with stroke and 44 caregivers. Participants will be randomized to either the intervention group, receiving 12 weeks of intensive hand therapy using the robotic glove and gaming interface (7 days per week, 2 hours per day) followed by a 6-month unsupervised home-based phase, or the control (comparator) group, receiving a dose-matched therapy program without the robotic glove over the same timeline. Feasibility will be evaluated through clinical study measures (recruitment and enrollment rates, adherence, retention, intervention delivery fidelity, workflow/process), clinical measures (M-TEI, FMA-UE, ARAT, COPM), technical indicators of reliability, safety, personalization, and maintenance needs, and economic measures related to personnel, space, equipment, and participant time and expenses. Assessments will be completed at baseline, weeks 4, 8, and 12, and at 2- and 6-month post-therapy follow-up points. Quantitative analysis will follow an intention-to-treat approach using repeated-measures ANOVA and descriptive costing, while qualitative data will undergo inductive thematic analysis to capture participant and therapist experiences and identify considerations for refining and scaling the intervention in a future large-scale trial.
Interventions
DEVICEWearable Assistive and Rehabilitation robot facilitating Intensive Telerehabilitation Program
The WEAR-IT program is an evidence-based, high-dose, technology-supported stroke rehabilitation intervention co-developed by our team and people living with stroke. Informed by the Medical Research Council framework for complex interventions, development involves evidence-based rehabilitation and neuroplasticity principles. The program underscores a higher treatment intensity-12 weeks, with greater frequency, repetitions, and extended therapy duration. It is intended to help participants apply their acquired function into daily activities through goal-oriented practice in real-world contexts. The program uses the HERO glove, a soft, untethered, and wearable robotic device that allows five-finger extension and grip assistance. This glove offers multiple control modes, including motion flicks, button activation, or adaptive feedback based on person's performance during virtual reality gaming activities. The program has in-person, telerehabilitation, and unsupervised home sessions.
OTHERDose-Matched Therapy Program
Participants in the dose-matched comparator group will receive the same intensity and frequency of in-person, telerehabilitation, and unsupervised sessions as those in the intervention group. However, they will not use the HERO glove or the virtual reality gaming interface.
Sponsors
Dr. Rosalie Wang
Sunnybrook Research Institute (Toronto, Ontario)
University of Toronto
University of Ontario Institute of Technology
University of Alberta
Glenrose Foundation
University of Waterloo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
We will also mask the student researchers conducting data analysis, along with two of the four investigators (one at the Toronto site and one at the Edmonton site). Since the intervention involves technology, participants, caregivers, and care providers and research coordinators cannot be masked. The investigator who will oversees the study and randomization and the investigator responsible for providing technology training will also be unmasked.
Intervention model description
To evaluate the feasibility of the WEAR-IT program, we will conduct a single-blind (masked), multi-site feasibility RCT using a mixed methods design, incorporating qualitative and quantitative approaches. Consented participants enrolled at each site will be randomly assigned to either the intervention or comparator group (Intervention: n = 10 participants/site × 2 sites = 20 + 2; Comparator: n = 10 participants/site × 2 sites = 20 + 2). We will employ a variable block randomization method, to assign participants in the intervention arm and comparator arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Each participant must meet all of the following inclusion criteria to participate in this study: A) Persons with chronic stroke: 1. Be able to attend one rehabilitation site (Toronto or Edmonton), 2. Be 18 years of age or older, 3. Be able to provide informed consent, 4. Has English language proficiency, 5. Be in the chronic stage of recovery (e.g., \> 6 months post-stroke), 6. Have hand recovery at Stage 1 (flaccid paralysis) to Stage 4 (inability to make a fist and then extend the fingers fully) on the Chedoke-McMaster Stroke Assessment (CMSA) 7. Have a pain rating between 0/10 (no pain) and 4/10 (moderate pain) at rest and with assisted hand movement 8. Demonstrate the ability to understand and participate in a 3-month study program, 9. Live with someone or have someone consistently available (caregiver participant) who can help with setting up telerehabilitation equipment and assist with putting on/removing the Glove (as needed), and 10. Have access to a computer or tablet with a camera and a reliable internet connection for telerehabilitation sessions. B) Caregiver participants who are willing to assist people living with stroke can be included if they meet the following criteria: 1. Be 18 years of age or older, 2. Be able to provide informed consent , and 3. Be able to support glove donning/doffing, set-up, and therapy for people living with stroke at home.
Exclusion criteria
* All participants meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome measure 1: Adherence to prescribed therapy dose | Week 1, week 4, 8, 12, 20, 36 | Adherence will assess feasibility of the program by quantifying the extent to which participants complete the prescribed therapy dose (device usage log and therapist records) during the intervention period. Unit of Measure: Adherence (%) = 100 × (number of completed sessions ÷ prescribed sessions). Higher values indicate better program feasibility and implementation. |
| Primary Outcome Measure 2: Retention | Week 1, week 4, 8, 12, 20, 36 | Retention will assess feasibility by quantifying the proportion of participants who continue participation through scheduled sessions over follow-up. Unit of Measure: Retention (%) = 100 × (participants remaining in study/ participants enrolled). Higher values indicate greater feasibility and sustained engagement with the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome Measure 1: Fugl-Meyer Assessment - Upper Extremity (FMA-UE) score | Week 0, week 4, 8, 12, 20, 36 | The Fugl-Meyer Assessment for Upper Extremity is a standardized, performance-based measure used to assess motor recovery after stroke. The full assessment evaluates motor function, sensation, joint range of motion, and pain in the upper limb. Unit of Measure: Total scores range from 0 to 66, where higher scores indicate better motor and neurological function. Higher scores = better motor function, Score from 0-66 (66 best) |
| Secondary Outcome Measure 2: Action Research Arm Test (ARAT) score | Week 0, week 4, 8, 12, 20, 36 | The Action Research Arm Test is a standardized measure of upper-extremity functional performance. Unite of Measure: Scores range from 0 to 57, with higher scores indicating better arm and hand function. Higher scores = better function, Score from 0-57 (57 best) |
| Secondary Outcome Measure 3: Canadian Occupational Performance Measure (COPM) performance score | Week 0, week 4, 8, 12, 20, 36 | Using the COPM performance score, a participant-reported measure of occupational performance in self-identified activities. Unit of Measure: Scores range from 1 to 10, with higher scores indicating better perceived performance. Higher scores = better perceived performance |
| Secondary Outcome Measure 4: Canadian Occupational Performance Measure (COPM) satisfaction score | Week 0, week 4, 8, 12, 20, 36 | Using the COPM satisfaction score, a participant-reported measure of satisfaction with performance in self-identified activities. Unit of Measure: Scores range from 1 to 10, with higher scores indicating more satisfaction. Higher scores = greater satisfaction |
| Secondary Outcome Measure 5: Intervention acceptability score | Week 1, week 4, 8, 12, 20, 36 | Acceptability will be assessed using the Modified Treatment Evaluation Inventory, a validated 7-point Likert scale evaluating suitability, perceived effectiveness, and burden of the intervention. Unit of Measure: Score from 0-7 (7best). Higher scores = greater acceptability. |
| Secondary Outcome Measure 6: Intervention delivery fidelity | Week 1, 4, 8, 12, 20, 36 | Intervention delivery fidelity will be assessed using a developed checklist for interventions: Unit of Measure: A high level of fidelity is defined as a score of at least 85% on the fidelity log, indicating that the intervention components were delivered according to the protocol. |
| Secondary Outcome Measure 7: Study feasibility-recruitment rate | Recruitment period | It is the number of participants recruited over the recruitment period. Unit of Measure: The number of eligible participants recruited over the total recruitment period (months). |
| Secondary Outcome Measure 8: Study feasibility-enrollment rate | Screening to enrollment period | It is number of enrolled participants over the total of participants screened. Unit of Measure: Total number of enrolled participants divided by the total number of screened over the recruitment period. |
| Secondary Outcome Measure 9: Study feasibility- process management | Week 1, 4, 8, 12, 20, 36 | Workflow using a developed study conduct checklist (from technology shipment to data analysis). Unit of Measure: Number of checklist items completed as planned |
| Secondary Outcome Measure 10: Technical feasibility-safety and adverse events | Week 1, 4, 8, 12, 20, 36 | Number, type, and severity of adverse events and safety concerns based on safety checklists and adverse event logs. Unit of Measure: Number of adverse events and safety incidents |
| Secondary Outcome Measure 11: Technical feasibility-ongoing risk management | Week 1, 4, 8, 12, 20, 36 | Using a pre-during-post intervention safety checklist. Unit of Measure: Number of checklist items completed at each stage |
| Secondary Outcome Measure12: Technical feasibility- Personalization requirements | Week 1, 4, 8, 12, 20, 36 | Extent of modifications needed to individualize use including task intensity and modification/ adaptation. Unit of Measure: Number of required modifications/adaptations per participant |
| Secondary Outcome Measure 13: Technical feasibility- design feedback and recommendations | Week 1, 4, 8, 12, 20, 36 | Therapist's feedback on issues, suggested adjustments and related rational. Unit of Measure: Number of documented feedback items/themes |
| Secondary Outcome Measure 14: Technical feasibility- data utility | Week 1, 4, 8, 12, 20, 36 | Data uploaded summary, data quality check, issues reporting and resolution log. Unit of Measure: Number of properly uploaded datasets completed data quality. |
| Secondary Outcome Measure 15: Technology feasibility-maintenance | Week 1, 4, 8, 12, 20, 36 | Required maintenance including Technical Issues Encountered during the session, providing support. Unit of Measure: The number of issues and proper support provided. |
| Secondary Outcome Measure 16: Economic feasibility-administrative cost | From enrollment to end of follow-up at week 36 | Will be evaluated using required time spent by non-therapeutic personnel /hour, required space/hour, required equipment /hour during process. Unit of Measure: Per hour personnel, space and equipment costs- CAD. |
| Secondary Outcome Measure 17: Economic feasibility-therapeutic staff cost | Week 1, 4, 8, 12, 20, 36 | will be assessed using personnel time required for intervention delivery by therapists and assessors. Unit of Measure: Per hour costs of intervention delivery by therapists. |
| Secondary Outcome Measure 18: Economic feasibility- participant cost | Week 1, 4, 8, 12, 20, 36 | Will be assessed through documenting cost related to participants (e.g., transportation, internet usage). Unit of Measure: Per hour costs related to participants. |
Countries
Canada
Contacts
CONTACTRosalie Wang, BSc.OT, PhD
CONTACTSareh Zarshenas, PhD
PRINCIPAL_INVESTIGATORRosalie Wang, BSc.OT, PhD
Sunnybrook Health Sciences Centre
PRINCIPAL_INVESTIGATORSander Hitzig, PhD
Sunnybrook Health Sciences Centre
PRINCIPAL_INVESTIGATORAaron Yurkewich, PhD
Ontario Tech University
PRINCIPAL_INVESTIGATORAdriana Rios Rincon, PhD
University of Alberta
Outcome results
None listed