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Recruiting NCT07467785

Reaching the Unreached: Home-Based Telerehabilitation for Stroke Survivors

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard of Care (SOC), Telerehabilitation with Tenzr.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Reaching the Unreached: Randomized Trial of Home-Based Telerehabilitation for Stroke Without Outpatient Care

Overview

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

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

Primary outcome measures

  • Change in Upper Extremity Fugl-Meyer Assessment for Upper Extremity (FM-UE) [Time frame: Baseline, 8 weeks and 16 weeks.]
Secondary outcome measures (4)
  • Change in Nine-hole Peg Test (NHPT) (sec) [Time frame: Baseline, 8 weeks, 16 weeks]
  • Change in Box and Blocks Test (number of blocks) [Time frame: Baseline, 8 weeks, 16 weeks]
  • Change in Stroke Impact Scale Score [Time frame: Baseline, 8 weeks, 16 weeks]
  • Change in PROMIS Upper Extremity Short Form [Time frame: Baseline, 8 weeks, 16 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Glenrose Rehabilitation Hospital — Edmonton

Identifiers

NCT: NCT07467785 · Pro00157166

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗