Feasibility Evaluation of WEAR-IT for Hand Therapy After Stroke (WEAR-IT)
Feasibility Evaluation of WEAR-IT (Wearable Assistive and Rehabilitation Robot Facilitating Intensive Telerehabilitation) for Hand Therapy After Stroke: A Randomized Controlled Trial
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Rosalie Wang, BSc.OT, PhD
- Numero di telefono: 416-946-8566
- Email: rosalie.wang@utoronto.ca
Backup dei contatti dello studio
- Nome: Sareh Zarshenas, PhD
- Email: sareh.zarshenas@sri.utoronto.ca
Luoghi di studio
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Alberta
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Edmonton, Alberta, Canada, T5G 0B7
- Glenrose Rehabilitation Hospital
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Contatto:
- Adriana Ríos Rincón, PhD
- Numero di telefono: 780-492-5150
- Email: aros@ualberta.ca
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Contatto:
- Andrew Chan, MD, PhD
- Email: andrew.chan@albertahealthservices.ca
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Ontario
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Toronto, Ontario, Canada, M2M 2G1
- Sunnybrook - St. John's Rehab
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Contatto:
- Rosalie Wang, BSc.OT, PhD
- Numero di telefono: 416-946-8566
- Email: rosalie.wang@utoronto.ca
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Contatto:
- Sareh Zarshenas, PhD
- Email: sareh.zarshenas@utoronto.ca
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Investigatore principale:
- Sander Hitzig, PhD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Fattibilità del dispositivo
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Intervention arm
The intervention arm will receive the hand-robot therapy program.
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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.
Altri nomi:
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Altro: Comparator arm
The comparator arm will receive the non-hand robot therapy program.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Primary Outcome measure 1: Adherence to prescribed therapy dose
Lasso di tempo: Week 1, week 4, 8, 12, 20, 36
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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
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Primary Outcome Measure 2: Retention
Lasso di tempo: Week 1, week 4, 8, 12, 20, 36
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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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Secondary Outcome Measure 1: Fugl-Meyer Assessment - Upper Extremity (FMA-UE) score
Lasso di tempo: Week 0, week 4, 8, 12, 20, 36
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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)
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Week 0, week 4, 8, 12, 20, 36
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Secondary Outcome Measure 2: Action Research Arm Test (ARAT) score
Lasso di tempo: Week 0, week 4, 8, 12, 20, 36
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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) |
Week 0, week 4, 8, 12, 20, 36
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Secondary Outcome Measure 3: Canadian Occupational Performance Measure (COPM) performance score
Lasso di tempo: Week 0, week 4, 8, 12, 20, 36
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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 |
Week 0, week 4, 8, 12, 20, 36
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Secondary Outcome Measure 4: Canadian Occupational Performance Measure (COPM) satisfaction score
Lasso di tempo: Week 0, week 4, 8, 12, 20, 36
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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 |
Week 0, week 4, 8, 12, 20, 36
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Secondary Outcome Measure 5: Intervention acceptability score
Lasso di tempo: Week 1, week 4, 8, 12, 20, 36
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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.
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Week 1, week 4, 8, 12, 20, 36
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Secondary Outcome Measure 6: Intervention delivery fidelity
Lasso di tempo: 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. |
Week 1, 4, 8, 12, 20, 36
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Secondary Outcome Measure 7: Study feasibility-recruitment rate
Lasso di tempo: Recruitment period
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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).
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Recruitment period
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Secondary Outcome Measure 8: Study feasibility-enrollment rate
Lasso di tempo: Screening to enrollment period
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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.
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Screening to enrollment period
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Secondary Outcome Measure 9: Study feasibility- process management
Lasso di tempo: Week 1, 4, 8, 12, 20, 36
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Workflow using a developed study conduct checklist (from technology shipment to data analysis).
Unit of Measure: Number of checklist items completed as planned
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Week 1, 4, 8, 12, 20, 36
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Secondary Outcome Measure 10: Technical feasibility-safety and adverse events
Lasso di tempo: Week 1, 4, 8, 12, 20, 36
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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 |
Week 1, 4, 8, 12, 20, 36
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Secondary Outcome Measure 11: Technical feasibility-ongoing risk management
Lasso di tempo: Week 1, 4, 8, 12, 20, 36
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Using a pre-during-post intervention safety checklist.
Unit of Measure: Number of checklist items completed at each stage
|
Week 1, 4, 8, 12, 20, 36
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Secondary Outcome Measure12: Technical feasibility- Personalization requirements
Lasso di tempo: Week 1, 4, 8, 12, 20, 36
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Extent of modifications needed to individualize use including task intensity and modification/ adaptation. Unit of Measure: Number of required modifications/adaptations per participant |
Week 1, 4, 8, 12, 20, 36
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Secondary Outcome Measure 13: Technical feasibility- design feedback and recommendations
Lasso di tempo: Week 1, 4, 8, 12, 20, 36
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Therapist's feedback on issues, suggested adjustments and related rational.
Unit of Measure: Number of documented feedback items/themes
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Week 1, 4, 8, 12, 20, 36
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Secondary Outcome Measure 14: Technical feasibility- data utility
Lasso di tempo: Week 1, 4, 8, 12, 20, 36
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Data uploaded summary, data quality check, issues reporting and resolution log.
Unit of Measure: Number of properly uploaded datasets completed data quality.
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Week 1, 4, 8, 12, 20, 36
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Secondary Outcome Measure 15: Technology feasibility-maintenance
Lasso di tempo: Week 1, 4, 8, 12, 20, 36
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Required maintenance including Technical Issues Encountered during the session, providing support. Unit of Measure: The number of issues and proper support provided. |
Week 1, 4, 8, 12, 20, 36
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Secondary Outcome Measure 16: Economic feasibility-administrative cost
Lasso di tempo: From enrollment to end of follow-up at week 36
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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. |
From enrollment to end of follow-up at week 36
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Secondary Outcome Measure 17: Economic feasibility-therapeutic staff cost
Lasso di tempo: Week 1, 4, 8, 12, 20, 36
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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. |
Week 1, 4, 8, 12, 20, 36
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Secondary Outcome Measure 18: Economic feasibility- participant cost
Lasso di tempo: Week 1, 4, 8, 12, 20, 36
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Will be assessed through documenting cost related to participants (e.g., transportation, internet usage). Unit of Measure: Per hour costs related to participants. |
Week 1, 4, 8, 12, 20, 36
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Adriana Rios Rincon, PhD, University of Alberta
- Investigatore principale: Rosalie Wang, BSc.OT, PhD, Sunnybrook Health Sciences Centre
- Investigatore principale: Sander Hitzig, PhD, Sunnybrook Health Sciences Centre
- Investigatore principale: Aaron Yurkewich, PhD, Ontario Tech University
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- REB Project ID Number 6708
- 189985 (Altro numero di sovvenzione/finanziamento: Canadian Institutes of Health Research)
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