Stroke (6 Months or More After Onset)WEAR-ITNCT07698067
Feasibility Evaluation of WEAR-IT for Hand Therapy After Stroke
A study testing Wearable Assistive and Rehabilitation robot facilitating Intensive Telerehabilitation Program and Dose-Matched Therapy Program in people with Stroke (6 Months or More After Onset), run by Dr. Rosalie Wang at 2 sites in Canada.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke (6 Months or More After Onset)
- What is being tested?
- Wearable Assistive and Rehabilitation robot facilitating Intensive Telerehabilitation Program and Dose-Matched Therapy Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Sep 2026to 23 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each participant must meet all of the following inclusion criteria to participate in this study:
- 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,
Show all 16Show fewer
- 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.
- 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.
Who cannot join
- All participants meeting any of the following exclusion criteria at baseline will be excluded from participation in this study:
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sareh Zarshenas, PhD contact
Canada2 sites
Glenrose Rehabilitation Hospital
Edmonton, Alberta, T5G 0B7
Adriana Ríos Rincón, PhD, 780-492-5150, aros@ualberta.ca
Andrew Chan, MD, PhD, andrew.chan@albertahealthservices.ca
Sunnybrook - St. John's Rehab
Toronto, Ontario, M2M 2G1
Rosalie Wang, BSc.OT, PhD, 416-946-8566, rosalie.wang@utoronto.ca
Sareh Zarshenas, PhD, sareh.zarshenas@utoronto.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke (6 Months or More After Onset)
- Being tested
- Wearable Assistive and Rehabilitation robot facilitating Intensive Telerehabilitation Program, Dose-Matched Therapy Program
- Keywords
- Stroke, Hand function, Robotic exoskeleton, Virtual care, Rehabilitation, Neurological rehabilitation, Hand therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Assistive and Rehabilitation robot facilitating Intensive Telerehabilitation ProgramDevice
Also called WEAR-IT 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.
Dose-Matched Therapy ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | The intervention arm will receive the hand-robot therapy program. Receives: Device: Wearable Assistive and Rehabilitation robot facilitating Intensive Telerehabilitation Program |
| Comparator arm | Other | The comparator arm will receive the non-hand robot therapy program. Receives: Other: Dose-Matched Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 1, week 4, 8, 12, 20, 36
Secondary outcomes (18)
Secondary Outcome Measure 1: Fugl-Meyer Assessment - Upper Extremity (FMA-UE) score
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)
Measured: Week 0, week 4, 8, 12, 20, 36
Secondary Outcome Measure 2: Action Research Arm Test (ARAT) score
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)
Measured: Week 0, week 4, 8, 12, 20, 36
Secondary Outcome Measure 3: Canadian Occupational Performance Measure (COPM) performance score
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
Measured: Week 0, week 4, 8, 12, 20, 36
Secondary Outcome Measure 4: Canadian Occupational Performance Measure (COPM) satisfaction score
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
Measured: Week 0, week 4, 8, 12, 20, 36
Secondary Outcome Measure 5: Intervention acceptability score
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.
Measured: Week 1, week 4, 8, 12, 20, 36
Secondary Outcome Measure 6: Intervention delivery fidelity
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.
Measured: Week 1, 4, 8, 12, 20, 36
Secondary Outcome Measure 7: Study feasibility-recruitment rate
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).
Measured: Recruitment period
Secondary Outcome Measure 8: Study feasibility-enrollment rate
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.
Measured: Screening to enrollment period
Secondary Outcome Measure 9: Study feasibility- process management
Workflow using a developed study conduct checklist (from technology shipment to data analysis). Unit of Measure: Number of checklist items completed as planned
Measured: Week 1, 4, 8, 12, 20, 36
Secondary Outcome Measure 10: Technical feasibility-safety and adverse events
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
Measured: Week 1, 4, 8, 12, 20, 36
Secondary Outcome Measure 11: Technical feasibility-ongoing risk management
Using a pre-during-post intervention safety checklist. Unit of Measure: Number of checklist items completed at each stage
Measured: Week 1, 4, 8, 12, 20, 36
Secondary Outcome Measure12: Technical feasibility- Personalization requirements
Extent of modifications needed to individualize use including task intensity and modification/ adaptation.
Unit of Measure: Number of required modifications/adaptations per participant
Measured: Week 1, 4, 8, 12, 20, 36
Secondary Outcome Measure 13: Technical feasibility- design feedback and recommendations
Therapist's feedback on issues, suggested adjustments and related rational. Unit of Measure: Number of documented feedback items/themes
Measured: Week 1, 4, 8, 12, 20, 36
Secondary Outcome Measure 14: Technical feasibility- data utility
Data uploaded summary, data quality check, issues reporting and resolution log. Unit of Measure: Number of properly uploaded datasets completed data quality.
Measured: Week 1, 4, 8, 12, 20, 36
Secondary Outcome Measure 15: Technology feasibility-maintenance
Required maintenance including Technical Issues Encountered during the session, providing support.
Unit of Measure: The number of issues and proper support provided.
Measured: Week 1, 4, 8, 12, 20, 36
Secondary Outcome Measure 16: Economic feasibility-administrative cost
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.
Measured: From enrollment to end of follow-up at week 36
Secondary Outcome Measure 17: Economic feasibility-therapeutic staff cost
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.
Measured: Week 1, 4, 8, 12, 20, 36
Secondary Outcome Measure 18: Economic feasibility- participant cost
Will be assessed through documenting cost related to participants (e.g., transportation, internet usage).
Unit of Measure: Per hour costs related to participants.
Measured: Week 1, 4, 8, 12, 20, 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion23 Dec 2027 (estimated)
- Study completion23 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke (6 Months or More After Onset)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Rosalie Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Research Institute (Toronto, Ontario), University of Toronto, University of Ontario Institute of Technology, University of Alberta, Glenrose Foundation, University of Waterloo
- Responsible party
- Sponsor-investigator, Dr. Rosalie Wang, Sunnybrook Health Sciences Centre
- Investigators
- Rosalie Wang, BSc.OT, PhD, Principal investigator, Sunnybrook Health Sciences CentreSander Hitzig, PhD, Principal investigator, Sunnybrook Health Sciences CentreAaron Yurkewich, PhD, Principal investigator, Ontario Tech UniversityAdriana Rios Rincon, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698067
- Sponsor's protocol ID
- REB Project ID Number 6708
- Other IDs
- 189985
- Acronym
- WEAR-IT
- Status last verified
- Jul 2026
- First submitted
- 8 Apr 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Evaluation of WEAR-IT (Wearable Assistive and Rehabilitation Robot Facilitating Intensive Telerehabilitation) for Hand Therapy After Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07698067
- Acronym / sponsor ID
- WEAR-IT / REB Project ID Number 6708
- Conditions
- Stroke (6 Months or More After Onset)
- Keywords
- Stroke, Hand function, Robotic exoskeleton, Virtual care, Rehabilitation, Neurological rehabilitation, Hand therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Dr. Rosalie WangUniversity, hospital or other
- Collaborators
- Sunnybrook Research Institute (Toronto, Ontario), University of Toronto, University of Ontario Institute of Technology, University of Alberta, Glenrose Foundation, University of Waterloo
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 23 Dec 2027 (estimated)
- Study completion
- 23 Dec 2029 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: Wearable Assistive and Rehabilitation robot facilitating Intensive Telerehabilitation ProgramThe intervention arm will receive the hand-robot therapy program. |
| Comparator arm | Other | Other: Dose-Matched Therapy ProgramThe comparator arm will receive the non-hand robot therapy program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Each participant must meet all of the following inclusion criteria to participate in this study:
- 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,
Key exclusion criteria (7 listed)
- All participants meeting any of the following exclusion criteria at baseline will be excluded from participation in this study:
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Assistive and Rehabilitation robot facilitating Intensive Telerehabilitation ProgramAlso: WEAR-IT programThe 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. | Device | Intervention arm |
| Dose-Matched Therapy ProgramParticipants 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. | Other | Comparator arm |
Primary outcome
Primary Outcome measure 1: Adherence to prescribed therapy dose
Time frame: Week 1, week 4, 8, 12, 20, 36
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.
Primary Outcome Measure 2: Retention
Time frame: Week 1, week 4, 8, 12, 20, 36
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.
18 secondary outcomes
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
Secondary Outcome Measure 13: Technical feasibility- design feedback and recommendations
Time frame: Week 1, 4, 8, 12, 20, 36
Secondary Outcome Measure 14: Technical feasibility- data utility
Time frame: Week 1, 4, 8, 12, 20, 36
Secondary Outcome Measure 15: Technology feasibility-maintenance
Time frame: Week 1, 4, 8, 12, 20, 36
Secondary Outcome Measure 16: Economic feasibility-administrative cost
Time frame: From enrollment to end of follow-up at week 36
Secondary Outcome Measure 17: Economic feasibility-therapeutic staff cost
Time frame: Week 1, 4, 8, 12, 20, 36
Secondary Outcome Measure 18: Economic feasibility- participant cost
Time frame: Week 1, 4, 8, 12, 20, 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sareh Zarshenas, PhD contact
Rosalie Wang, BSc.OT, PhD principal investigator
Sunnybrook Health Sciences Centre
Sander Hitzig, PhD principal investigator
Sunnybrook Health Sciences Centre
Aaron Yurkewich, PhD principal investigator
Ontario Tech University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Assistive and Rehabilitation robot facilitating Intensive Telerehabilitation Program and Dose-Matched Therapy Program in people with Stroke (6 Months or More After Onset), run by Dr. Rosalie Wang at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rosalie Wang, BSc.OT, PhD (416-946-8566, rosalie.wang@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome measure 1: Adherence to prescribed therapy dose (time frame: Week 1, week 4, 8, 12, 20, 36). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.