Reaching the Unreached: Home-Based Telerehabilitation for Stroke Survivors

NCT07467785 | Recruiting

• 1 other identifier: Pro00157166
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

rehabilitation; telerehabilitation; neurorecovery

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 8 weeks and 16 weeks.

Secondary Outcomes (4)

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

  Baseline, 8 weeks, 16 weeks

• Change in Box and Blocks Test (number of blocks)

  Baseline, 8 weeks, 16 weeks

• Change in Stroke Impact Scale Score

  Baseline, 8 weeks, 16 weeks

• Change in PROMIS Upper Extremity Short Form

  Baseline, 8 weeks, 16 weeks

Other Outcomes (3)

• System Usability Scale (Tech eval)

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

• Client Satisfaction Questionnaire (CSQ-8)

  At completion of trial (16 weeks)

• Participant adherence (%, rate of planned sessions completed)

  Collected continuously using the Tenzr application during the telerehabilitation phase of the trial (either baseline-8week block or 8week-16week block dependent on randomization).

Study Arms (2)

Immediate Group

ACTIVE COMPARATOR

The Immediate group will receive 8 weeks of home-based telerehabilitation using the Tenzr platform immediately after baseline clinical assessments.

Other: Standard of Care (SOC); Other: Telerehabilitation with Tenzr

Delayed Group

ACTIVE COMPARATOR

Delayed group will receive 8 weeks of observation (usual care) following the baseline clinical assessment; followed by 8 weeks of the same telerehabilitation intervention.

Other: Standard of Care (SOC); Other: Telerehabilitation with Tenzr

Interventions

Standard of Care (SOC) OTHER

8 weeks of standard of care for patients discharged from hospital without referrals to outpatient rehabilitation.

Delayed Group; Immediate Group

Telerehabilitation with Tenzr OTHER

8 weeks of telerehabilitation at home supported by a remote therapist utilizing the Tenzr application.

Delayed Group; Immediate Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Innovates Health Solutions: collaborator
• Glenrose Hospital Foundation: collaborator

Study Sites (1)

Glenrose Rehabilitation Hospital

Edmonton, Alberta, T5G 0B7, Canada

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Standard of Care; Telerehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management

Study Officials

• Jessica M D'Amico, PhD

  University of Alberta and Alberta Health Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica M D'Amico, Scientific Program Lead and Assistant Professor, PhD

CONTACT

780-203-9478; damico1@ualberta.ca

Yoshino Okuma, BScRN, MSc

CONTACT

yokuma@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: March 12, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)