A New At-home Telerehabilitation Care Service Delivery Model for Stroke Survivors in the Rio Grande Valley

NCT ID: NCT06580548

Last Updated: 2025-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-17

Study Completion Date

2025-12-30

Brief Summary

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The purpose of this study is to investigate the feasibility of a mobile telerehabilitation software for post-acute stroke care for Rio Grande Valley (RGV) stroke survivors with community health worker (CHW) at-home support and to estimate the functional health, mental health (depression), and caregiver burden outcomes of this new CHW-supported, at-home rehabilitation service delivery model and to identify salient barriers to and facilitators of adopting and delivering the new rehabilitation delivery model to further disseminate the model in real-world communities.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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CHW-supported telerehabilitation plus Usual Care

Group Type EXPERIMENTAL

CHW-supported telerehabilitation

Intervention Type DEVICE

Participants will receive the Mobile Rehab mobile software, which allows participants to be prescribed personalized rehabilitation strengthening video regimens electronically based on respondent-indicated mobility and activities of daily living functionality

Usual Care

Intervention Type OTHER

Participants will be provide a list of local social services resources, including mental health, that participants can use . A callback number will be provided if they have any questions about the services.

Interventions

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CHW-supported telerehabilitation

Participants will receive the Mobile Rehab mobile software, which allows participants to be prescribed personalized rehabilitation strengthening video regimens electronically based on respondent-indicated mobility and activities of daily living functionality

Intervention Type DEVICE

Usual Care

Participants will be provide a list of local social services resources, including mental health, that participants can use . A callback number will be provided if they have any questions about the services.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* A resident of the Brownsville, Texas (Cameron County) area
* SINGLE and FIRST qualifying stroke event with the ability to enroll and begin study activities within 3 months of onset of stroke event
* Pre-stroke modified Rankin score of ≤3 (less than moderate disability at baseline)
* Currently uninsured
* Spanish or English speaker
* Able to follow instructions (without aphasia that interferes with following instructions)
* Safe to perform basic strengthening rehabilitation exercises
* Able to stand with or without assistance

Exclusion Criteria

* Aphasia or cognitive impairment (e.g., dementia) that interferes with following instructions or prevents following the study-related activities)
* Pre-stroke motor deficits
* Current psychiatric disorders, including substance use disorder
* Underlying brain pathologies inclusive of brain malignancies, multiple sclerosis
* Insured patients as insured patients are referred for standard-of-care clinical rehabilitation.
* Medical instability to participate in basic strengthening rehabilitation exercises
* Inability to access internet from home to access at-home rehabilitation software for intervention arm participants
* Having received any outpatient rehabilitation services prior to study enrollment for intervention arm participants
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Fadi Musfee

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fadi Musfee, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Fadi Musfee, MD

Role: CONTACT

(956) 755-0630

Ruth S Yanes Bengoa

Role: CONTACT

(713) 500-7934

Facility Contacts

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Fadi Musfee, MD

Role: primary

956-755-0630

Ruth S Yanes Bengoa

Role: backup

(713) 500-7934

Other Identifiers

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1UM1TR004906

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC-SPH-24-0166

Identifier Type: -

Identifier Source: org_study_id

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