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Behavioural Intervention

Telerehabilitation for Stroke Survivors

N/A

Waitlist Available

Led By Fadi Musfee, MD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pre-stroke modified Rankin score of ≤3 (less than moderate disability at baseline)

Be older than 18 years old

Must not have

Having received any outpatient rehabilitation services prior to study enrollment for intervention arm participants

Aphasia or cognitive impairment (e.g., dementia) that interferes with following instructions or prevents following the study-related activities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test a new mobile telerehabilitation software for stroke survivors in the Rio Grande Valley. The software will be supported by community health workers who will provide at-home assistance. The study

Who is the study for?

This trial is for stroke survivors in Brownsville, Texas who can stand (with help if needed), had their first stroke within the last 3 months, and were not severely disabled before the stroke. Participants must be uninsured, speak Spanish or English, able to do basic exercises safely, and follow instructions despite any aphasia.

What is being tested?

The study tests a new at-home telerehabilitation service with community health worker support against usual care. It aims to see how well it works for improving physical and mental health of stroke survivors in Rio Grande Valley and understand barriers and facilitators for its use.

What are the potential side effects?

Since this trial involves rehabilitation exercises supported by technology and community workers rather than medication, side effects are minimal but may include typical exercise-related risks such as muscle soreness or strain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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Before my stroke, I had little to no disability.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received outpatient rehab services before joining this study.

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I do not have any conditions like aphasia or dementia that make it hard for me to follow instructions.

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I have a brain condition like cancer or multiple sclerosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 1), week 3 (intervention participants only), week 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 1), week 3 (intervention participants only), week 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 1), week 3 (intervention participants only), week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Depression as assessed by the Patient Health Questionnaire 9 (PHQ-9)

Change in Health-related quality of life as assessed by the European Health-Related Quality of Life- 5 Dimensions (EQ-5D) EuroQoL-5D five-level survey (EQ-5D-5L)

Change in basic activity as Acute Measure for Post-Acute Care (AM-PAC) Daily Activity Outpatient Short Form (low function)

+4 more

Secondary study objectives

Acceptability & Appropriateness of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire

Acceptability/Appropriateness of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire

Adherence as assessed by the number of rehab videos watched in a day

+3 more