Feasibility Evaluation of WEAR-IT for Hand Therapy After Stroke

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)

Interventions

DEVICE

Wearable 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.

OTHER

Dose-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 & Collaborators

• Sunnybrook Research Institute (Toronto, Ontario)

  collaborator UNKNOWN

• University of Toronto

  collaborator OTHER

• University of Ontario Institute of Technology

  collaborator OTHER

• University of Alberta

  collaborator OTHER

• Glenrose Foundation

  collaborator OTHER

• University of Waterloo

  collaborator OTHER

• Dr. Rosalie Wang

  lead OTHER

Principal Investigators

• Rosalie Wang, BSc.OT, PhD · Sunnybrook Health Sciences Centre

• Sander Hitzig, PhD · Sunnybrook Health Sciences Centre

• Aaron Yurkewich, PhD · Ontario Tech University

• Adriana Rios Rincon, PhD · University of Alberta

Study Design

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2027-12-23

Completion

2029-12-23

Countries

• Canada

Study Locations