Stroke
Conditions
Keywords
rehabilitation, telerehabilitation, neurorecovery
Brief summary
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.
Interventions
OTHERStandard of Care (SOC)
8 weeks of standard of care for patients discharged from hospital without referrals to outpatient rehabilitation.
OTHERTelerehabilitation with Tenzr
8 weeks of telerehabilitation at home supported by a remote therapist utilizing the Tenzr application.
Sponsors
University of Alberta
Alberta Innovates Health Solutions
Glenrose Hospital Foundation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This project will employ a randomized, delayed-start controlled crossover design within a hybrid Type I effectiveness-implementation trial framework. Two hundred individuals with post-stroke upper extremity impairment, who have not been referred to outpatient rehabilitation, 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. All participants will be assessed at baseline, 8 weeks, and 16 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Not currently referred to, or participating in, upper extremity outpatient rehabilitation. 2. A confirmed stroke diagnosis (ischemic or hemorrhagic) 3. Have moderate-to-severe upper limb impairment 4. Live at home 5. Have access to internet and appropriate devices to have a virtual assessment with clinicians. 6. ≥ 18 years of age
Exclusion criteria
1. Referred to or currently participating in upper extremity outpatient rehabilitation. 2. Severe cognitive, communication, or medical comorbidities that would preclude safe home-based exercise 3. Don't have access to internet and appropriate devices to have a virtual assessment with clinicians. 4. \< 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Upper Extremity Fugl-Meyer Assessment for Upper Extremity (FM-UE) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Nine-hole Peg Test (NHPT) (sec) | 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. |
| Change in Box and Blocks Test (number of blocks) | 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. |
| Change in Stroke Impact Scale Score | 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. |
| Change in PROMIS Upper Extremity Short Form | 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. |
Countries
Canada
Contacts
CONTACTJessica M D'Amico, Scientific Program Lead and Assistant Professor, PhD
CONTACTYoshino Okuma, BScRN, MSc
PRINCIPAL_INVESTIGATORJessica M D'Amico, PhD
University of Alberta and Alberta Health Services
Outcome results
None listed