Reaching the Unreached: Home-Based Telerehabilitation for Stroke Survivors

ConditionStroke

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorUniversity of Alberta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

Standard of Care (SOC)
Other intervention
8 weeks of standard of care for patients discharged from hospital without referrals to outpatient rehabilitation.
Telerehabilitation with Tenzr
Other intervention
8 weeks of telerehabilitation at home supported by a remote therapist utilizing the Tenzr application.

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: Immediate GroupActive comparator 2 interventions

Group B: Delayed GroupActive comparator 2 interventions

Trial outcomes

Primary outcomes

Change in Upper Extremity Fugl-Meyer Assessment for Upper Extremity (FM-UE)

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 and 16 weeks.

Secondary outcomes

Change in Nine-hole Peg Test (NHPT) (sec)

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

Change in Box and Blocks Test (number of blocks)

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

Change in Stroke Impact Scale Score

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

Change in PROMIS Upper Extremity Short Form

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

Baseline, 8 weeks, 16 weeks

Other outcomes

System Usability Scale (Tech eval)

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 Tenzr-supported rehab phase (either 8 or 16 weeks dependent on randomization).

Client Satisfaction Questionnaire (CSQ-8)

The Client Satisfaction Questionnaire (CSQ-8) is one of a limited number of standardised satisfaction measures that have been used widely.

Time frame

At completion of trial (16 weeks)

Participant adherence (%, rate of planned sessions completed)

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.

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).

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Alberta Innovates Health Solutions

Collaborator

Glenrose Hospital Foundation

Collaborator

Source ClinicalTrials.gov

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