NCT06289569

Home Tele Rehabilitation Therapy for Vascular Dementia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Dementia, Vascular
• Stroke Sequelae

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-14
• Primary completion: 2028-03-14
• Completion: 2028-04-01
• First posted: 2024-03-04
• Last updated: 2026-03-02

Locations

1 site across 1 country: United States