StrokeNCT06580548
A New At-home Telerehabilitation Care Service Delivery Model for Stroke Survivors in the Rio Grande Valley
A study testing CHW-supported telerehabilitation in people with Stroke, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- CHW-supported telerehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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.
- Conditions
- Stroke
- Being tested
- CHW-supported telerehabilitation, Usual Care
- Keywords
- long-term rehabilitation management, stroke survivor, telehealth
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHW-supported telerehabilitationDevice
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CHW-supported telerehabilitation plus Usual Care | Experimental | Not described Receives: Device: CHW-supported telerehabilitation; Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in basic mobility as assessed by the Acute Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Form (routine)
This is an 18 item questionnaire and each is scored from 1(unable) to 4( none) for a score range of 1-72, higher score indicating better outcome
Measured: Baseline (week 1), week 3 (intervention participants only), week 6
Change in basic mobility as assessed by the Acute Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Form (low function )
This is a 19 item questionnaire and each is scored from 0(unable) to 3( none) for a score range of 0-57, higher score indicating better outcome
Measured: Baseline (week 1), week 3 (intervention participants only), week 6
Change in basic activity as Acute Measure for Post-Acute Care (AM-PAC) Daily Activity Outpatient Short Form (routine)
This is a 15 item questionnaire and each is scored from 1(unable) to 4( none) for a score range of 1-60, higher score indicating better outcome
Measured: Baseline (week 1), week 3 (intervention participants only), week 6
Change in basic activity as Acute Measure for Post-Acute Care (AM-PAC) Daily Activity Outpatient Short Form (low function)
This is a 12 item questionnaire and each is scored from 0(total) to 3( none) for a score range of 1-36, higher score indicating better outcome
Measured: Baseline (week 1), week 3 (intervention participants only), week 6
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)
This is scored across 5 dimensions , mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and each dimension is scored on a five-level severity ranking that ranges from 1 (no problems) to 5 (extreme problems), higher score indicating worse outcome
Measured: Baseline, week 3 (intervention participants only), week 6
Change in Depression as assessed by the Patient Health Questionnaire 9 (PHQ-9)
This is a 9 item questionnaire and each is scored from 0(not at all) to 3(nearly every day) for a score range of 0-27, higher score indicating worse outcome
Measured: Baseline, week 3 (intervention participants only), week 6
Change in caregiver burden as assessed by the Zarit Burden Interview
This is a 12 item questionnaire and each is scored from 0(never) to 4(nearly always) for a score range of 0-48, higher score indicating worse outcome
Measured: Baseline, week 3 (intervention participants only), week 6
Secondary outcomes (13)
Acceptability/Appropriateness of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire
This is an 8 item questionnaire and each is scored from 1( strongly disagree) to 5(strongly agree) for a score range of 1-40, higher score indicating better outcome
Measured: Baseline
Acceptability/Appropriateness of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire
This is an 8 item questionnaire and each is scored from 1( strongly disagree) to 5(strongly agree) for a score range of 1-40, higher score indicating better outcome
Measured: week 7
Adoption of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire
This is an 5 item questionnaire and each is scored from 1( strongly disagree) to 5(strongly agree) for a score range of 1-25, higher score indicating better outcome
Measured: Baseline
Adoption of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire
This is an 5 item questionnaire and each is scored from 1( strongly disagree) to 5(strongly agree) for a score range of 1-25, higher score indicating better outcome
Measured: week 7
Acceptability & Appropriateness of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire
This is an 7 item questionnaire and each is scored from 1( strongly disagree) to 5(strongly agree) for a score range of 1-35, higher score indicating better outcome
Measured: Baseline
Acceptability & Appropriateness of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire
This is an 7 item questionnaire and each is scored from 1( strongly disagree) to 5(strongly agree) for a score range of 1-35, higher score indicating better outcome
Measured: week 7
Adoption of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire
This is an 4 item questionnaire and each is scored from 1( strongly disagree) to 5(strongly agree) for a score range of 1-20, higher score indicating better outcome
Measured: Baseline
Adoption of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire
This is an 4 item questionnaire and each is scored from 1( strongly disagree) to 5(strongly agree) for a score range of 1-20, higher score indicating better outcome
Measured: week 7
Feasibility of Community Health Worker as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire
This is an 7 item questionnaire and each is scored from 1( strongly disagree) to 5(strongly agree) for a score range of 1-35, higher score indicating better outcome
Measured: Baseline
Feasibility of Community Health Worker as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire
This is an 7 item questionnaire and each is scored from 1( strongly disagree) to 5(strongly agree) for a score range of 1-35, higher score indicating better outcome
Measured: week 7 (immediately after intervention)
Feasibility as assessed by the number of participants enrolled
Measured: end of study (week 7)
Adherence as assessed by the number of rehab videos watched in a day
adherence is defined by ≥1 daily mobile rehab video usage
Measured: end of study (week 7)
Number of participants that view ≥1 daily mobile rehab videos
Measured: end of study (week 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start17 Mar 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Fadi Musfee, The University of Texas Health Science Center, Houston
- Investigators
- Fadi Musfee, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580548
- Sponsor's protocol ID
- HSC-SPH-24-0166
- Other IDs
- 1UM1TR004906
- Status last verified
- Mar 2026
- First submitted
- 29 Aug 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New At-home Telerehabilitation Care Service Delivery Model for Stroke Survivors in the Rio Grande Valley
- ClinicalTrials.gov ID
- NCT06580548
- Acronym / sponsor ID
- HSC-SPH-24-0166
- Conditions
- Stroke
- Keywords
- long-term rehabilitation management, stroke survivor, telehealth
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 11 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHW-supported telerehabilitation plus Usual Care | Experimental | Device: CHW-supported telerehabilitation, Other: Usual Care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHW-supported telerehabilitationParticipants 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 | Device | CHW-supported telerehabilitation plus Usual Care |
| Usual CareParticipants 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. | Other | CHW-supported telerehabilitation plus Usual Care |
Primary outcome
Change in basic mobility as assessed by the Acute Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Form (routine)
Time frame: Baseline (week 1), week 3 (intervention participants only), week 6
This is an 18 item questionnaire and each is scored from 1(unable) to 4( none) for a score range of 1-72, higher score indicating better outcome
Change in basic mobility as assessed by the Acute Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Form (low function )
Time frame: Baseline (week 1), week 3 (intervention participants only), week 6
This is a 19 item questionnaire and each is scored from 0(unable) to 3( none) for a score range of 0-57, higher score indicating better outcome
Change in basic activity as Acute Measure for Post-Acute Care (AM-PAC) Daily Activity Outpatient Short Form (routine)
Time frame: Baseline (week 1), week 3 (intervention participants only), week 6
This is a 15 item questionnaire and each is scored from 1(unable) to 4( none) for a score range of 1-60, higher score indicating better outcome
Change in basic activity as Acute Measure for Post-Acute Care (AM-PAC) Daily Activity Outpatient Short Form (low function)
Time frame: Baseline (week 1), week 3 (intervention participants only), week 6
This is a 12 item questionnaire and each is scored from 0(total) to 3( none) for a score range of 1-36, higher score indicating better outcome
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)
Time frame: Baseline, week 3 (intervention participants only), week 6
This is scored across 5 dimensions , mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and each dimension is scored on a five-level severity ranking that ranges from 1 (no problems) to 5 (extreme problems), higher score indicating worse outcome
Change in Depression as assessed by the Patient Health Questionnaire 9 (PHQ-9)
Time frame: Baseline, week 3 (intervention participants only), week 6
This is a 9 item questionnaire and each is scored from 0(not at all) to 3(nearly every day) for a score range of 0-27, higher score indicating worse outcome
Change in caregiver burden as assessed by the Zarit Burden Interview
Time frame: Baseline, week 3 (intervention participants only), week 6
This is a 12 item questionnaire and each is scored from 0(never) to 4(nearly always) for a score range of 0-48, higher score indicating worse outcome
13 secondary outcomes
Acceptability/Appropriateness of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire
Time frame: Baseline
Acceptability/Appropriateness of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire
Time frame: week 7
Adoption of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire
Time frame: Baseline
Adoption of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire
Time frame: week 7
Acceptability & Appropriateness of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire
Time frame: Baseline
Acceptability & Appropriateness of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire
Time frame: week 7
Adoption of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire
Time frame: Baseline
Adoption of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire
Time frame: week 7
Feasibility of Community Health Worker as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire
Time frame: Baseline
Feasibility of Community Health Worker as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire
Time frame: week 7 (immediately after intervention)
Feasibility as assessed by the number of participants enrolled
Time frame: end of study (week 7)
Adherence as assessed by the number of rehab videos watched in a day
Time frame: end of study (week 7)
Number of participants that view ≥1 daily mobile rehab videos
Time frame: end of study (week 7)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fadi Musfee, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHW-supported telerehabilitation in people with Stroke, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in basic mobility as assessed by the Acute Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Form (routine) (time frame: Baseline (week 1), week 3 (intervention participants only), week 6). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.