Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07698067

Feasibility Evaluation of WEAR-IT for Hand Therapy After Stroke

Sponsor: Dr. Rosalie Wang

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-09-01

Completion Date

2029-12-23

Last Updated

2026-07-13

Healthy Volunteers

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.

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 exclusion criteria at baseline will be excluded from participation in this study: A) Persons with chronic stroke: 1. Have no limitations in fully extending fingers or making a fist, 2. Are experiencing pain or cognitive impairments that prevent active participation in therapy, 3. Be unable to communicate with therapists independently, 4. Have had any musculoskeletal or other neurological conditions that would impact their participation in a hand rehabilitation program, or 5. Are currently involved in another rehabilitation program aimed at improving upper limb movement.

Locations (2)

Glenrose Rehabilitation Hospital

Edmonton, Alberta, Canada

Sunnybrook - St. John's Rehab

Toronto, Ontario, Canada