- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07467785
Reaching the Unreached: Home-Based Telerehabilitation for Stroke Survivors
Reaching the Unreached: Randomized Trial of Home-Based Telerehabilitation for Stroke Without Outpatient Care
After a stroke, many people have trouble using their arms and hands. This can make daily tasks-like eating, dressing, or writing-very hard. In Alberta, especially in small towns and rural areas, many stroke survivors go home from the hospital without being referred to rehabilitation. As a result, they miss out on therapy that could help them get better.
This project will test a new way to bring rehabilitation directly into people's homes using telerehabilitation. We will work with 200 stroke survivors across Alberta who did not get regular outpatient rehab. Participants will use the clinically validated Tenzr system-a set of fun, game-like exercises with wearable sensors. Therapists will check in and guide them remotely.
When participants are enrolled in the study, they will be randomized (1:1) into two groups. The Immediate group will receive 8 weeks of home-based telerehabilitation using the Tenzr platform immediately after baseline, while the Delayed group will receive 8 weeks of observation (usual care) followed by 8 weeks of the same telerehabilitation intervention. Everyone in the study will be tested at the baseline, 8 weeks, and 16 weeks. At 16 weeks, we will also interview them to gather their feedback on the telerehabilitation. We want to learn if this program helps people improve arm and hand movement, if it's easy to use, and if people like it. We also want to see if it could be offered more widely across Alberta in the future.
The goal is to give more people access to stroke rehabilitation, no matter where they live.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jessica M D'Amico, Scientific Program Lead and Assistant Professor, PhD
- Phone Number: 780-203-9478
- Email: damico1@ualberta.ca
Study Contact Backup
- Name: Yoshino Okuma, BScRN, MSc
- Email: yokuma@ualberta.ca
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T5G 0B7
- Recruiting
- Glenrose Rehabilitation Hospital
-
Principal Investigator:
- Jessica M D'Amico, PhD
-
Contact:
- Yoshino Okuma, BScRN, MSc
- Email: yokuma@ualberta.ca
-
Contact:
- Jessica M D'Amico, Scientific Program Lead, Assistant Professor, PhD
- Email: damico1@ualberta.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Not currently referred to, or participating in, upper extremity outpatient rehabilitation.
- A confirmed stroke diagnosis (ischemic or hemorrhagic)
- Have moderate-to-severe upper limb impairment
- Live at home
- Have access to internet and appropriate devices to have a virtual assessment with clinicians.
- ≥ 18 years of age
Exclusion Criteria:
- Referred to or currently participating in upper extremity outpatient rehabilitation.
- Severe cognitive, communication, or medical comorbidities that would preclude safe home-based exercise
- Don't have access to internet and appropriate devices to have a virtual assessment with clinicians.
- < 18 years of age
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Immediate Group
The Immediate group will receive 8 weeks of home-based telerehabilitation using the Tenzr platform immediately after baseline clinical assessments.
|
8 weeks of standard of care for patients discharged from hospital without referrals to outpatient rehabilitation.
8 weeks of telerehabilitation at home supported by a remote therapist utilizing the Tenzr application.
|
|
Active Comparator: Delayed Group
Delayed group will receive 8 weeks of observation (usual care) following the baseline clinical assessment; followed by 8 weeks of the same telerehabilitation intervention.
|
8 weeks of standard of care for patients discharged from hospital without referrals to outpatient rehabilitation.
8 weeks of telerehabilitation at home supported by a remote therapist utilizing the Tenzr application.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Upper Extremity Fugl-Meyer Assessment for Upper Extremity (FM-UE)
Time Frame: Baseline, 8 weeks and 16 weeks.
|
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index.
It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
We will be obtaining and reporting the Upper Extremity subscore.
It is a score without units.
|
Baseline, 8 weeks and 16 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Nine-hole Peg Test (NHPT) (sec)
Time Frame: Baseline, 8 weeks, 16 weeks
|
The NHPT requires participants to repeatedly place and then remove nine pegs into nine holes, one at a time, as quickly as possible.
|
Baseline, 8 weeks, 16 weeks
|
|
Change in Box and Blocks Test (number of blocks)
Time Frame: Baseline, 8 weeks, 16 weeks
|
The Box and Block Test (BBT) measures unilateral gross manual dexterity.
It is a quick, simple and inexpensive test.
It can be used with a wide range of populations, including clients with stroke.
|
Baseline, 8 weeks, 16 weeks
|
|
Change in Stroke Impact Scale Score
Time Frame: Baseline, 8 weeks, 16 weeks
|
The Stroke Impact Scale (SIS) is a patient-reported outcome measure that evaluates the biopsychosocial aspects of life after stroke.
No units.
|
Baseline, 8 weeks, 16 weeks
|
|
Change in PROMIS Upper Extremity Short Form
Time Frame: Baseline, 8 weeks, 16 weeks
|
PROMIS® stands for Patient Reported Outcomes Measurement Information System, which is a system of highly reliable, precise measures of patient-reported health status for physical, mental, and social well-being.
PROMIS® tools measure what patients are able to do and how they feel by asking a number of questions.
The PROMIS v1. 2 UE item bank is a useful clinical assessment tool with good psychometric properties that can be implemented in clinical settings and is focused on upper extremity items.
|
Baseline, 8 weeks, 16 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
System Usability Scale (Tech eval)
Time Frame: At completion of Tenzr-supported rehab phase (either 8 or 16 weeks dependent on randomization).
|
The system usability scale (SUS) is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability.
|
At completion of Tenzr-supported rehab phase (either 8 or 16 weeks dependent on randomization).
|
|
Client Satisfaction Questionnaire (CSQ-8)
Time Frame: At completion of trial (16 weeks)
|
The Client Satisfaction Questionnaire (CSQ-8) is one of a limited number of standardised satisfaction measures that have been used widely.
|
At completion of trial (16 weeks)
|
|
Participant adherence (%, rate of planned sessions completed)
Time Frame: Collected continuously using the Tenzr application during the telerehabilitation phase of the trial (either baseline-8week block or 8week-16week block dependent on randomization).
|
Using the Tenzr application we will report the rate of completed sessions by recording the # rehab sessions completed by the participants using the application versus the planned # rehab sessions and expressed as a percentage.
|
Collected continuously using the Tenzr application during the telerehabilitation phase of the trial (either baseline-8week block or 8week-16week block dependent on randomization).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jessica M D'Amico, PhD, University of Alberta and Alberta Health Services
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Stroke
- Health Services Administration
- Delivery of Health Care
- Health Care Quality, Access, and Evaluation
- Therapeutics
- Quality of Health Care
- Quality Indicators, Health Care
- Patient Care
- Health Services
- Health Care Facilities Workforce and Services
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Telemedicine
- Patient Care Management
- Standard of Care
- Telerehabilitation
Other Study ID Numbers
- Pro00157166
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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