NCT Number: NCT07467785
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Edmonton, Alberta, T5G 0B7, Canada
Location status: Recruiting
Jessica M D'Amico, PhD
PRINCIPAL_INVESTIGATOR
Jessica M D'Amico, Scientific Program Lead, Assistant Professor, PhD
CONTACT
Yoshino Okuma, BScRN, MSc
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Jessica M D'Amico, Scientific Program Lead and Assistant Professor, PhD
CONTACT
Yoshino Okuma, BScRN, MSc
CONTACT
University of Alberta
Other
Reaching the Unreached: Randomized Trial of Home-Based Telerehabilitation for Stroke Without Outpatient Care
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