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NCT Number: NCT07698067

Feasibility Evaluation of WEAR-IT for Hand Therapy After Stroke

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.

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Key information

Conditions

Stroke (6 Months or More After Onset) Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glenrose Rehabilitation Hospital, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Each participant must meet all of the following inclusion criteria to participate in this study:

A) Persons with chronic stroke:

  • Be able to attend one rehabilitation site (Toronto or Edmonton),
  • Be 18 years of age or older,
  • Be able to provide informed consent,
  • Has English language proficiency,
  • Be in the chronic stage of recovery (e.g., > 6 months post-stroke),
  • 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)
  • Have a pain rating between 0/10 (no pain) and 4/10 (moderate pain) at rest and with assisted hand movement
  • Demonstrate the ability to understand and participate in a 3-month study program,
  • 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
  • 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:

  • Be 18 years of age or older,
  • Be able to provide informed consent , and
  • 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 exclusion criteria at baseline will be excluded from participation in this study:

A) Persons with chronic stroke:

  • Have no limitations in fully extending fingers or making a fist,
  • Are experiencing pain or cognitive impairments that prevent active participation in therapy,
  • Be unable to communicate with therapists independently,
  • Have had any musculoskeletal or other neurological conditions that would impact their participation in a hand rehabilitation program, or
  • Are currently involved in another rehabilitation program aimed at improving upper limb movement.

Treatment and study plan

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.

Other names: WEAR-IT program

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.

Primary outcomes

  1. Primary Outcome measure 1: Adherence to prescribed therapy dose

    Time frame: 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.

  2. Primary Outcome Measure 2: Retention

    Time frame: 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 outcomes

  1. Secondary Outcome Measure 1: Fugl-Meyer Assessment - Upper Extremity (FMA-UE) score

    Time frame: 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)

  2. Secondary Outcome Measure 2: Action Research Arm Test (ARAT) score

    Time frame: 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)

  3. Secondary Outcome Measure 3: Canadian Occupational Performance Measure (COPM) performance score

    Time frame: 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

  4. Secondary Outcome Measure 4: Canadian Occupational Performance Measure (COPM) satisfaction score

    Time frame: 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

  5. Secondary Outcome Measure 5: Intervention acceptability score

    Time frame: 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.

  6. Secondary Outcome Measure 6: Intervention delivery fidelity

    Time frame: 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.

  7. Secondary Outcome Measure 7: Study feasibility-recruitment rate

    Time frame: 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).

  8. Secondary Outcome Measure 8: Study feasibility-enrollment rate

    Time frame: 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.

  9. Secondary Outcome Measure 9: Study feasibility- process management

    Time frame: 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

  10. Secondary Outcome Measure 10: Technical feasibility-safety and adverse events

    Time frame: 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

  11. Secondary Outcome Measure 11: Technical feasibility-ongoing risk management

    Time frame: 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

  12. Secondary Outcome Measure12: Technical feasibility- Personalization requirements

    Time frame: 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

  13. Secondary Outcome Measure 13: Technical feasibility- design feedback and recommendations

    Time frame: 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

  14. Secondary Outcome Measure 14: Technical feasibility- data utility

    Time frame: 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.

  15. Secondary Outcome Measure 15: Technology feasibility-maintenance

    Time frame: 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.

  16. Secondary Outcome Measure 16: Economic feasibility-administrative cost

    Time frame: 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.

  17. Secondary Outcome Measure 17: Economic feasibility-therapeutic staff cost

    Time frame: 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.

  18. Secondary Outcome Measure 18: Economic feasibility- participant cost

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rosalie Wang, BSc.OT, PhD

CONTACT

[email protected]

416-946-8566

Sareh Zarshenas, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Dr. Rosalie Wang

Other

Collaborators

  • Glenrose Foundation
  • Sunnybrook Research Institute (Toronto, Ontario)
  • University of Alberta
  • University of Ontario Institute of Technology
  • University of Toronto
  • University of Waterloo

Registry information

Official study title

Feasibility Evaluation of WEAR-IT (Wearable Assistive and Rehabilitation Robot Facilitating Intensive Telerehabilitation) for Hand Therapy After Stroke: A Randomized Controlled Trial

Acronym: WEAR-IT

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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