Dementia, VascularNCT06289569
Home Tele Rehabilitation Therapy for Vascular Dementia
A study testing Home telerehabilitation therapy in people with Dementia, Vascular and Stroke Sequelae, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
To determine whether the home telerehabilitation therapy is feasible and lessens caregiver burden in chronic stroke patients with and without vascular dementia (VaD) Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Dementia, Vascular, Stroke Sequelae
- What is being tested?
- Home telerehabilitation therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2024to 1 Apr 2028
- 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 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic ischemic or hemorrhagic stroke verified by computerized axial tomography or magnetic resonance imaging
- at least 6 months post stroke
- At least some active movement in the affected upper extremity (MRS 1 or more in shoulder elbow or wrist)
- Ability to provide informed consent, or LAR able to provide consent
- Expressed willingness to comply with all study procedures and attend all study-related visits for both the patient and at least one caregiver.
- Age ≥ 18.
Show all 11Show fewer
- Ability to follow one-step commands.
- Community-dwelling with transportation to evaluation sessions.
- Ability to operate the therapy system with minimal assistance, including sufficient corrected vision to perceive objects from a distance of 5 feet.
- Modified Ashworth Scale Score 3 or less in the involved upper extremity
- Passive range of motion within functional ranges at the shoulder, elbow, wrist and hand
Who cannot join
- Patients with history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as unable to follow study instructions even with help from caregiver).
- Patients with bilateral paresis, or weakness or sensory damage due to peripheral causes (e.g. peripheral nerve injury, muscle or orthopedic injury etc.)
- Patients with severe uncontrolled medical problems that would render intensive rehabilitation unfeasible or unsafe (e.g. cardiovascular disease, unstable cardiac arrhythmia, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age, epilepsy or others).
- Concurrent participation in other experimental upper extremity rehabilitation trials that would interfere with results.
- Non-English-speaking individuals will only be eligible if they can provide the appropriate translator for all the sessions of the study as no funding is available to pay for such services. However, we plan to include them once funding has been secured in the subsequent larger trial.
- Pregnancy
- Prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Timea Hodics, MD, 713-763-9589, tmhodics@houstonmethodist.org
About this study
To determine whether the home telerehabilitation therapy is feasible and lessens caregiver burden in chronic stroke patients with and without vascular dementia (VaD)
Read the detailed description
This is a controlled evaluator masked parallel study of chronic (>6mo from stroke onset) ischemic or hemorrhagic stroke patients diagnosed with and without vascular dementia to test the feasibility and effect of remote rehabilitation therapy targeting the weaker arm compared to usual care. All patients will undergo baseline evaluation, then usual care for 1 month followed by a remote telerehabilitation treatment for one month, followed by an evaluation 1 month after the completion of treatment.
Research procedures:
Subject Recruitment/Screening: Participants will be recruited from the PI's stroke recovery specialty clinic, and the Houston Methodist Hospital system by flyers and educating clinicians about the proposed study and the patient requirements. Prospective participants may also be identified through mining electronic medical records for ICD-9 and ICD-10 codes for stroke and hemiparesis for potentially eligible participants. Participants that appear to meet eligibility criteria based on the phone screening and medical record review will be invited to participate in an in-person screening session to ensure that they met the full inclusion criteria prior to being enrolled in the study.
Throughout all study visits subjects will be monitored for safety, comfort and any adverse events by trained study staff.
Initial Evaluation/Dependent Measures: The subject's initial evaluation will include questionnaires and impairment and functional scales. We will record demographic information, brain imaging, stroke history and medical history and medications from electronic medical records. We will store the deidentified brain imaging in XNAT under a study identifier on the secure server available at HMH.
Intervention:
All subjects will perform first their conventional home rehabilitation for 4 weeks followed by telerehabilitation therapy.
Occupational therapist prescribed hand/arm exercises will continue for 90 minutes per day with adequate rest periods.
Self-report measures will not be blinded. The investigator who determines the primary outcome measure will not be aware of treatment phase completed or prior performance (single-blind study design). Each treatment session will be expected to take approximately 1 hour 45 minute with prior setup and stretching. Treatment times can be broken up into multiple treatment periods to accommodate patient and caregiver preferences.
- Conditions
- Dementia, Vascular, Stroke Sequelae
- Being tested
- Home telerehabilitation therapy
- Medical subject headings
- Dementia, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home telerehabilitation therapyOther
Occupational therapist prescribed hand/arm exercises will be assigned to patients. Records of each subject's motor tasks, number of repetition and level of performance will be kept. Standard of care home therapy will be performed Monday-Friday for approximately 4 weeks, followed by 4 weeks of application-driven home teletherapy. It is expected that approximately 20 treatments will be finished in 4weeks, however the amount of therapy completed will be recorded to accommodate patients' schedules. Treatment times can be broken up into multiple treatment periods to accommodate patient and caregiver preferences.
| Study group | Role | What they receive |
|---|---|---|
| Tele Rehabilitation | Experimental | Telerehabilitation therapy Occupational therapist prescribed hand/arm exercises will continue for 90 minutes per day with adequate rest periods for 4 weeks, followed by telerehabilitation with the application for 4 weeks, when subjects will perform the tasks at home with the guidance of the treatment app. Detailed records of each subject's motor tasks, number of repetition and level of performance will be kept. Treatment will be performed Monday-Friday for approximately 4 weeks. Treatment times can be broken up into multiple treatment periods to accommodate patient and caregiver preferences. Receives: Other: Home telerehabilitation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burden Scale for Family Caregivers
Burden Scale for Family Caregivers BSFC-s[8] Subjective caregiver burden 10-item short version of the questionnaire.
Measured: 3-4 months
Adverse events
Prospective record of adverse events including dropouts
Measured: 3-4 months
Secondary outcomes (2)
Fugl-Meyer Upper extremity assessment
The uFM test measures both proximal and distal upper extremity movements. Intratester and intertester reliability and validity of the Fugl-Meyer scale is well established in stroke patients. A score ranges 0-66, higher scores are better.
Measured: 3-4 months
Wolf Motor Function Test (WMFT)
The WMFT is a time-based method to evaluate upper extremity performance of 17 tasks while providing insight into joint-specific and total limb movements. Lower time scores mean better motor function.
Measured: 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start14 Dec 2024
- Primary completion14 Mar 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia, VascularStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timea Hodics, The Methodist Hospital Research Institute
- Investigators
- Timea Hodics, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289569
- Sponsor's protocol ID
- PRO00037243
- Status last verified
- Feb 2026
- First submitted
- 21 Feb 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Tele Rehabilitation Therapy for Vascular Dementia
- ClinicalTrials.gov ID
- NCT06289569
- Acronym / sponsor ID
- PRO00037243
- Conditions
- Dementia, Vascular, Stroke Sequelae
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 14 Dec 2024 (actual)
- Primary completion
- 14 Mar 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 4 Mar 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.
To determine whether the home telerehabilitation therapy is feasible and lessens caregiver burden in chronic stroke patients with and without vascular dementia (VaD)
Detailed description
This is a controlled evaluator masked parallel study of chronic (>6mo from stroke onset) ischemic or hemorrhagic stroke patients diagnosed with and without vascular dementia to test the feasibility and effect of remote rehabilitation therapy targeting the weaker arm compared to usual care. All patients will undergo baseline evaluation, then usual care for 1 month followed by a remote telerehabilitation treatment for one month, followed by an evaluation 1 month after the completion of treatment.
Research procedures:
Subject Recruitment/Screening: Participants will be recruited from the PI's stroke recovery specialty clinic, and the Houston Methodist Hospital system by flyers and educating clinicians about the proposed study and the patient requirements. Prospective participants may also be identified through mining electronic medical records for ICD-9 and ICD-10 codes for stroke and hemiparesis for potentially eligible participants. Participants that appear to meet eligibility criteria based on the phone screening and medical record review will be invited to participate in an in-person screening session to ensure that they met the full inclusion criteria prior to being enrolled in the study.
Throughout all study visits subjects will be monitored for safety, comfort and any adverse events by trained study staff.
Initial Evaluation/Dependent Measures: The subject's initial evaluation will include questionnaires and impairment and functional scales. We will record demographic information, brain imaging, stroke history and medical history and medications from electronic medical records. We will store the deidentified brain imaging in XNAT under a study identifier on the secure server available at HMH.
Intervention:
All subjects will perform first their conventional home rehabilitation for 4 weeks followed by telerehabilitation therapy.
Occupational therapist prescribed hand/arm exercises will continue for 90 minutes per day with adequate rest periods.
Self-report measures will not be blinded. The investigator who determines the primary outcome measure will not be aware of treatment phase completed or prior performance (single-blind study design). Each treatment session will be expected to take approximately 1 hour 45 minute with prior setup and stretching. Treatment times can be broken up into multiple treatment periods to accommodate patient and caregiver preferences.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tele Rehabilitation | Experimental | Other: Home telerehabilitation therapyTelerehabilitation therapy Occupational therapist prescribed hand/arm exercises will continue for 90 minutes per day with adequate rest periods for 4 weeks, followed by telerehabilitation with the application for 4 weeks, when subjects will perform the tasks at home with the guidance of the treatment app. Detailed records of each subject's motor tasks, number of repetition and level of performance will be kept. Treatment will be performed Monday-Friday for approximately 4 weeks. Treatment times can be broken up into multiple treatment periods to accommodate patient and caregiver preferences. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Symptomatic ischemic or hemorrhagic stroke verified by computerized axial tomography or magnetic resonance imaging
- at least 6 months post stroke
- At least some active movement in the affected upper extremity (MRS 1 or more in shoulder elbow or wrist)
- Ability to provide informed consent, or LAR able to provide consent
- Expressed willingness to comply with all study procedures and attend all study-related visits for both the patient and at least one caregiver.
Key exclusion criteria (7 listed)
- Patients with history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as unable to follow study instructions even with help from caregiver).
- Patients with bilateral paresis, or weakness or sensory damage due to peripheral causes (e.g. peripheral nerve injury, muscle or orthopedic injury etc.)
- Patients with severe uncontrolled medical problems that would render intensive rehabilitation unfeasible or unsafe (e.g. cardiovascular disease, unstable cardiac arrhythmia, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age, epilepsy or others).
- Concurrent participation in other experimental upper extremity rehabilitation trials that would interfere with results.
- Non-English-speaking individuals will only be eligible if they can provide the appropriate translator for all the sessions of the study as no funding is available to pay for such services. However, we plan to include them once funding has been secured in the subsequent larger trial.
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 |
|---|---|---|
| Home telerehabilitation therapyOccupational therapist prescribed hand/arm exercises will be assigned to patients. Records of each subject's motor tasks, number of repetition and level of performance will be kept. Standard of care home therapy will be performed Monday-Friday for approximately 4 weeks, followed by 4 weeks of application-driven home teletherapy. It is expected that approximately 20 treatments will be finished in 4weeks, however the amount of therapy completed will be recorded to accommodate patients' schedules. Treatment times can be broken up into multiple treatment periods to accommodate patient and caregiver preferences. | Other | Tele Rehabilitation |
Primary outcome
Burden Scale for Family Caregivers
Time frame: 3-4 months
Burden Scale for Family Caregivers BSFC-s[8] Subjective caregiver burden 10-item short version of the questionnaire.
Adverse events
Time frame: 3-4 months
Prospective record of adverse events including dropouts
2 secondary outcomes
Fugl-Meyer Upper extremity assessment
Time frame: 3-4 months
Wolf Motor Function Test (WMFT)
Time frame: 3-4 months
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 2 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Timea Hodics, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home telerehabilitation therapy in people with Dementia, Vascular and Stroke Sequelae, run by The Methodist Hospital Research Institute 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 11 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 2 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?
Contact Darrel W Cleere, MPH ((713)-441-3770, dwcleere@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burden Scale for Family Caregivers (time frame: 3-4 months). The study lists 2 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 2 Mar 2026.