StrokeVAST-rehabNCT05659784
Virtually Assisted Home Rehabilitation After Acute STroke (VAST-rehab)
A study testing 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 virtual education and virtual visit program in engaging patients with rehabilitation at home after stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Telerehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2020to 8 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent provided by the subject or legally authorized representative.
- Occurrence of a hemorrhagic or ischemic stroke
- pre-stroke mRS less than 3
- Qualifying Stroke Event must be confirmed by CT or MRI
- Recommended to participate in self-guided or in-person rehabilitation activities by a physician or rehabilitation therapist
- Must have sufficient cognitive and language abilities to comprehend verbal commands and to carry out the study assessments
- Able to access the internet via a personal device
Who cannot join
- . History of neurological or other disease resulting in significant functional impairment (e.g.Parkinson's disease, motor neuron disease, moderate dementia, arthritis,contractures or fixed anatomical abnormality).
- Subjects with a severe comorbid disorder that has reasonable likelihood of limiting survival to less than 6 months.
- Any other conditions that, in the opinion of the investigators, would preclude safe and/or effective participation.
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 virtual education and virtual visit program in engaging patients with rehabilitation at home after stroke.
- Conditions
- Stroke
- Being tested
- Telerehabilitation
- Keywords
- rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
Education based telerehab with rehabilitation therapists providing education on home exercises and stroke specific information
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation | Experimental | Not described Receives: Other: Telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as assessed by number of participants that completed all scheduled visits.
Measured: end of study(12 weeks form baseline)
Secondary outcomes (8)
Change in Functional independence as assessed by the Functional Independence Measure (FIM)
This is an 18 item questionnaire and each is scored from 1(complete dependence on helper) to 7(complete independence), a higher number indicating more independence
Measured: Baseline, end of study (about 13-14 weeks after baseline)
Patient-Specific Functional Scale
This tool allows for Subjects to self report activities of daily living that have been affected by stroke and rate severity of impact on these activities. This is scored from 0(unable to perform activity) to 10(able to perform activity at the same level as before injury or problem)
Measured: Baseline, end of study (about 13-14 weeks after baseline)
Change in impact of stroke as assessed by the Stroke Impact Scale (SIS)
This is a A 59 item questionnaire whereby subjects identify the impact of stroke on strength, hand function, mobility, activities of daily living, memory, communication, emotion, and handicap. Item responses are scored on a 5-point Likert-style scale. A score of 1 = an inability to complete the item and a score of 5 = no difficulty experienced at all. A standardized score ranging from 0 to 100 is calculated for all domains, with higher scores indicating a higher quality of life
Measured: Baseline, end of study (about 13-14 weeks after baseline)
Change in quality of life as assessed by the EuroQol-5-5level scale (EQ-5D-5L)
A self reporting, quality of life measurement that asks Subjects to rate their severity of problems related to mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 5 questions in the first section and each question is scored from 0-5,a higher number indicating a worse outcome .There is a visual scale at the end that is scored from 0(worst health) to 100(best health), higher number indicating better outcome .
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Measured: Baseline, end of study (about 13-14 weeks after baseline)
Change in cognitive impairment as assessed by the Short Montreal Cognitive Assessment(s-MoCA)
8 item questionnaire ,with a possible score of 1-5, a lower number indicating higher cognitive impairment
Measured: Baseline, end of study (about 13-14 weeks after baseline)
Change in performance in activities of daily living as assessed by the Barthel Index
This is a scoring technique that measures performance in ten activities of daily living including feeding, wheelchair to bed transfers, grooming ,chair to toilet transfers, walking, using stairs, dressing, and continence of bowels and bladder. This is a 10 item questionnaire and is scored from 0-100, a higher score indicating higher level of independence.
Measured: Baseline, end of study (about 13-14 weeks after baseline)
Change in symptoms related to stroke as assessed by the National Institute of Health Stroke Scale(NIHSS)
the score for each ability is a number between 0(normal functioning) to 4(completely impaired). The score is calculated by adding the number for each element of the scale with a highest score of 42, a higher score meaning more impairment.
Measured: Baseline, end of study (about 13-14 weeks after baseline)
Change in degree of disability or dependence as measured by the Modified Rankin Score(mRS)
mRS is a 6 point disability scale with possible scores from 0(no disability) to 5(disability requiring constant care) a higher score indicating more disability
Measured: Baseline, end of study (about 13-14 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start20 Apr 2020
- Primary completion8 May 2023
- Study completion8 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Savitz, The University of Texas Health Science Center, Houston
- Investigators
- Sean Savitz, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659784
- Sponsor's protocol ID
- HSC-MS-20-0384
- Acronym
- VAST-rehab
- Status last verified
- Feb 2024
- First submitted
- 12 Dec 2022
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stevens EA, Muraly N, Da Silva CP, Richards L, Sosa A, Smith H, Richard AS, Manji S, Russell ME, Savitz SI. Virtually assisted home rehabilitation after acute stroke (VAST-rehab): A descriptive pilot study for young and underserved stroke survivors. Digit Health. 2025 Mar 17;11:20552076251324443. doi: 10.1177/20552076251324443. eCollection 2025 Jan-Dec.
PubMed 40103648
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtually Assisted Home Rehabilitation After Acute STroke (VAST-rehab)
- ClinicalTrials.gov ID
- NCT05659784
- Acronym / sponsor ID
- VAST-rehab / HSC-MS-20-0384
- Conditions
- Stroke
- Keywords
- rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 21 Dec 2022 (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 virtual education and virtual visit program in engaging patients with rehabilitation at home after stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Other: Telerehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed consent provided by the subject or legally authorized representative.
- Occurrence of a hemorrhagic or ischemic stroke
- pre-stroke mRS less than 3
- Qualifying Stroke Event must be confirmed by CT or MRI
- Recommended to participate in self-guided or in-person rehabilitation activities by a physician or rehabilitation therapist
Key exclusion criteria (3 listed)
- . History of neurological or other disease resulting in significant functional impairment (e.g.Parkinson's disease, motor neuron disease, moderate dementia, arthritis,contractures or fixed anatomical abnormality).
- Subjects with a severe comorbid disorder that has reasonable likelihood of limiting survival to less than 6 months.
- Any other conditions that, in the opinion of the investigators, would preclude safe and/or effective participation.
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 |
|---|---|---|
| TelerehabilitationEducation based telerehab with rehabilitation therapists providing education on home exercises and stroke specific information | Other | Telerehabilitation |
Primary outcome
Feasibility as assessed by number of participants that completed all scheduled visits.
Time frame: end of study(12 weeks form baseline)
8 secondary outcomes
Change in Functional independence as assessed by the Functional Independence Measure (FIM)
Time frame: Baseline, end of study (about 13-14 weeks after baseline)
Patient-Specific Functional Scale
Time frame: Baseline, end of study (about 13-14 weeks after baseline)
Change in impact of stroke as assessed by the Stroke Impact Scale (SIS)
Time frame: Baseline, end of study (about 13-14 weeks after baseline)
Change in quality of life as assessed by the EuroQol-5-5level scale (EQ-5D-5L)
Time frame: Baseline, end of study (about 13-14 weeks after baseline)
Change in cognitive impairment as assessed by the Short Montreal Cognitive Assessment(s-MoCA)
Time frame: Baseline, end of study (about 13-14 weeks after baseline)
Change in performance in activities of daily living as assessed by the Barthel Index
Time frame: Baseline, end of study (about 13-14 weeks after baseline)
Change in symptoms related to stroke as assessed by the National Institute of Health Stroke Scale(NIHSS)
Time frame: Baseline, end of study (about 13-14 weeks after baseline)
Change in degree of disability or dependence as measured by the Modified Rankin Score(mRS)
Time frame: Baseline, end of study (about 13-14 weeks after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Derived from this study: PubMed 40103648Stevens EA, Muraly N, Da Silva CP, Richards L, Sosa A, Smith H, Richard AS, Manji S, Russell ME, Savitz SI. Virtually assisted home rehabilitation after acute stroke (VAST-rehab): A descriptive pilot study for young and underserved stroke survivors. Digit Health. 2025 Mar 17;11:20552076251324443. doi: 10.1177/20552076251324443. eCollection 2025 Jan-Dec.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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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.
Sean Savitz, 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 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 7 inclusion and 3 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: finished, as of the sponsor's last update on 23 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility as assessed by number of participants that completed all scheduled visits. (time frame: end of study(12 weeks form baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05659784, which also lists 1 linked publication.
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 23 Feb 2024.