Feasibility Evaluation of WEAR-IT for Hand Therapy After Stroke

Official title

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

Overview

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.

Detailed description

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.

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 t
• 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.

Primary outcome measures

• Primary Outcome measure 1: Adherence to prescribed therapy dose [Time frame: Week 1, week 4, 8, 12, 20, 36]
• Primary Outcome Measure 2: Retention [Time frame: Week 1, week 4, 8, 12, 20, 36]

Secondary outcome measures (12)

• Secondary Outcome Measure 1: Fugl-Meyer Assessment - Upper Extremity (FMA-UE) score [Time frame: Week 0, week 4, 8, 12, 20, 36]
• Secondary Outcome Measure 2: Action Research Arm Test (ARAT) score [Time frame: Week 0, week 4, 8, 12, 20, 36]
• Secondary Outcome Measure 3: Canadian Occupational Performance Measure (COPM) performance score [Time frame: Week 0, week 4, 8, 12, 20, 36]
• Secondary Outcome Measure 4: Canadian Occupational Performance Measure (COPM) satisfaction score [Time frame: Week 0, week 4, 8, 12, 20, 36]
• Secondary Outcome Measure 5: Intervention acceptability score [Time frame: Week 1, week 4, 8, 12, 20, 36]
• Secondary Outcome Measure 6: Intervention delivery fidelity [Time frame: Week 1, 4, 8, 12, 20, 36]
• Secondary Outcome Measure 7: Study feasibility-recruitment rate [Time frame: Recruitment period]
• Secondary Outcome Measure 8: Study feasibility-enrollment rate [Time frame: Screening to enrollment period]
• Secondary Outcome Measure 9: Study feasibility- process management [Time frame: Week 1, 4, 8, 12, 20, 36]
• Secondary Outcome Measure 10: Technical feasibility-safety and adverse events [Time frame: Week 1, 4, 8, 12, 20, 36]
• Secondary Outcome Measure 11: Technical feasibility-ongoing risk management [Time frame: Week 1, 4, 8, 12, 20, 36]
• Secondary Outcome Measure12: Technical feasibility- Personalization requirements [Time frame: Week 1, 4, 8, 12, 20, 36]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Device feasibility

Study locations

Canada · 2 centers

• Glenrose Rehabilitation Hospital — Edmonton
• Sunnybrook - St. John's Rehab — Toronto

Identifiers

NCT: NCT07698067 · REB Project ID Number 6708 · 189985

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗