Feasibility Evaluation of WEAR-IT for Hand Therapy After Stroke

NCT07698067 | Not Yet Recruiting DMC

• 2 other identifiers: REB Project ID Number 6708189985
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke (6 Months or More After Onset)

Keywords

Stroke; Hand function; Robotic exoskeleton; Virtual care; Rehabilitation; Neurological rehabilitation; Hand therapy

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (18)

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

  Week 0, week 4, 8, 12, 20, 36

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

  Week 0, week 4, 8, 12, 20, 36

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

  Week 0, week 4, 8, 12, 20, 36

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

  Week 0, week 4, 8, 12, 20, 36

• Secondary Outcome Measure 5: Intervention acceptability score

  Week 1, week 4, 8, 12, 20, 36

Study Arms (2)

Intervention arm

EXPERIMENTAL

The intervention arm will receive the hand-robot therapy program.

Device: Wearable Assistive and Rehabilitation robot facilitating Intensive Telerehabilitation Program

Comparator arm

OTHER

The comparator arm will receive the non-hand robot therapy program.

Other: Dose-Matched Therapy Program

Interventions

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.

Also known as: WEAR-IT program

Intervention arm

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.

Comparator arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Rosalie Wang: lead
• Sunnybrook Research Institute (Toronto, Ontario): collaborator
• University of Toronto: collaborator
• University of Ontario Institute of Technology: collaborator
• University of Alberta: collaborator
• Glenrose Foundation: collaborator
• University of Waterloo: collaborator

Study Sites (2)

Glenrose Rehabilitation Hospital

Edmonton, Alberta, T5G 0B7, Canada

Location

Sunnybrook - St. John's Rehab

Toronto, Ontario, M2M 2G1, Canada

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rosalie Wang, BSc.OT, PhD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Sander Hitzig, PhD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Aaron Yurkewich, PhD

  Ontario Tech University

  PRINCIPAL INVESTIGATOR

• Adriana Rios Rincon, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosalie Wang, BSc.OT, PhD

CONTACT

416-946-8566; rosalie.wang@utoronto.ca

Sareh Zarshenas, PhD

CONTACT

sareh.zarshenas@sri.utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Affiliate Scientist

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: July 13, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 23, 2027
• Study Completion (Estimated): December 23, 2029
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)