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RECRUITING

NCT06289569

Home Tele Rehabilitation Therapy for Vascular Dementia

Sponsor: The Methodist Hospital Research Institute

View on ClinicalTrials.gov

Summary

To determine whether the home telerehabilitation therapy is feasible and lessens caregiver burden in chronic stroke patients with and without vascular dementia (VaD)

Key Details

Gender

All

Age Range

18 Years - 110 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-12-14

Completion Date

2028-04-01

Last Updated

2026-03-02

Healthy Volunteers

Conditions

Dementia, Vascular Stroke Sequelae

Interventions

OTHER

Home telerehabilitation therapy

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.

Inclusion Criteria: * 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. * 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 Exclusion Criteria: * 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

Locations (1)

Houston Methodist Hospital

Houston, Texas, United States