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| ID | Type | Description | Link |
|---|---|---|---|
| 189985 | Other Grant/Funding Number | Canadian Institutes of Health Research |
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| Name | Class |
|---|---|
| Sunnybrook Research Institute (Toronto, Ontario) | UNKNOWN |
| University of Toronto | OTHER |
| University of Ontario Institute of Technology | OTHER |
| University of Alberta |
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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.
For both groups, researchers will record information about each participant's clinical recovery, their experience with the therapy process and the cost of care.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | The intervention arm will receive the hand-robot therapy program. |
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| Comparator arm | Other | The comparator arm will receive the non-hand robot therapy program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable Assistive and Rehabilitation robot facilitating Intensive Telerehabilitation Program | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome measure 1: Adherence to prescribed therapy dose | 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. | Week 1, week 4, 8, 12, 20, 36 |
| Primary Outcome Measure 2: Retention | 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. | Week 1, week 4, 8, 12, 20, 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome Measure 1: Fugl-Meyer Assessment - Upper Extremity (FMA-UE) score | 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) |
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Inclusion Criteria:
A) Persons with chronic stroke:
B) Caregiver participants who are willing to assist people living with stroke can be included if they meet the following criteria:
Exclusion Criteria:
A) Persons with chronic stroke:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rosalie Wang, BSc.OT, PhD | Contact | 416-946-8566 | rosalie.wang@utoronto.ca | |
| Sareh Zarshenas, PhD | Contact | sareh.zarshenas@sri.utoronto.ca |
| Name | Affiliation | Role |
|---|---|---|
| Rosalie Wang, BSc.OT, PhD | Sunnybrook Health Sciences Centre | Principal Investigator |
| Sander Hitzig, PhD | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glenrose Rehabilitation Hospital | Edmonton | Alberta | T5G 0B7 | Canada |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 7, 2025 | Dec 2, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: ICF-Patients | Nov 7, 2025 | Dec 2, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: ICF- Caregivers | Nov 7, 2025 | Dec 2, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| OTHER |
| Glenrose Foundation | OTHER |
| University of Waterloo | OTHER |
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.
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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.
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| Dose-Matched Therapy Program | Other | 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. |
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| Week 0, week 4, 8, 12, 20, 36 |
| Secondary Outcome Measure 2: Action Research Arm Test (ARAT) score | 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) | Week 0, week 4, 8, 12, 20, 36 |
| Secondary Outcome Measure 3: Canadian Occupational Performance Measure (COPM) performance score | 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 | Week 0, week 4, 8, 12, 20, 36 |
| Secondary Outcome Measure 4: Canadian Occupational Performance Measure (COPM) satisfaction score | 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 | Week 0, week 4, 8, 12, 20, 36 |
| Secondary Outcome Measure 5: Intervention acceptability score | 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. | Week 1, week 4, 8, 12, 20, 36 |
| Secondary Outcome Measure 6: Intervention delivery fidelity | 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. | Week 1, 4, 8, 12, 20, 36 |
| Secondary Outcome Measure 7: Study feasibility-recruitment rate | 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). | Recruitment period |
| Secondary Outcome Measure 8: Study feasibility-enrollment rate | 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. | Screening to enrollment period |
| Secondary Outcome Measure 9: Study feasibility- process management | Workflow using a developed study conduct checklist (from technology shipment to data analysis). Unit of Measure: Number of checklist items completed as planned | Week 1, 4, 8, 12, 20, 36 |
| Secondary Outcome Measure 10: Technical feasibility-safety and adverse events | 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 | Week 1, 4, 8, 12, 20, 36 |
| Secondary Outcome Measure 11: Technical feasibility-ongoing risk management | Using a pre-during-post intervention safety checklist. Unit of Measure: Number of checklist items completed at each stage | Week 1, 4, 8, 12, 20, 36 |
| Secondary Outcome Measure12: Technical feasibility- Personalization requirements | Extent of modifications needed to individualize use including task intensity and modification/ adaptation. Unit of Measure: Number of required modifications/adaptations per participant | Week 1, 4, 8, 12, 20, 36 |
| Secondary Outcome Measure 13: Technical feasibility- design feedback and recommendations | Therapist's feedback on issues, suggested adjustments and related rational. Unit of Measure: Number of documented feedback items/themes | Week 1, 4, 8, 12, 20, 36 |
| Secondary Outcome Measure 14: Technical feasibility- data utility | Data uploaded summary, data quality check, issues reporting and resolution log. Unit of Measure: Number of properly uploaded datasets completed data quality. | Week 1, 4, 8, 12, 20, 36 |
| Secondary Outcome Measure 15: Technology feasibility-maintenance | Required maintenance including Technical Issues Encountered during the session, providing support. Unit of Measure: The number of issues and proper support provided. | Week 1, 4, 8, 12, 20, 36 |
| Secondary Outcome Measure 16: Economic feasibility-administrative cost | 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. | From enrollment to end of follow-up at week 36 |
| Secondary Outcome Measure 17: Economic feasibility-therapeutic staff cost | 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. | Week 1, 4, 8, 12, 20, 36 |
| Secondary Outcome Measure 18: Economic feasibility- participant cost | Will be assessed through documenting cost related to participants (e.g., transportation, internet usage). Unit of Measure: Per hour costs related to participants. | Week 1, 4, 8, 12, 20, 36 |
| Aaron Yurkewich, PhD |
| Ontario Tech University |
| Principal Investigator |
| Adriana Rios Rincon, PhD | University of Alberta | Principal Investigator |
| Sunnybrook - St. John's Rehab | Toronto | Ontario | M2M 2G1 | Canada |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |