Home Tele Rehabilitation Therapy for Vascular Dementia

NCT06289569 | Recruiting

• 1 other identifier: PRO00037243
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dementia, Vascular; Stroke Sequelae

Outcome Measures

Primary Outcomes (2)

• Burden Scale for Family Caregivers

  Burden Scale for Family Caregivers BSFC-s\[8\] Subjective caregiver burden 10-item short version of the questionnaire.

  3-4 months

• Adverse events

  Prospective record of adverse events including dropouts

  3-4 months

Secondary Outcomes (2)

• Fugl-Meyer Upper extremity assessment

  3-4 months

• Wolf Motor Function Test (WMFT)

  3-4 months

Other Outcomes (2)

• Exercise log

  3-4 months

• Stroke Impact Scale

  3-4 months

Study Arms (1)

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.

Other: Home telerehabilitation therapy

Interventions

Home telerehabilitation therapy OTHER

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.

Tele Rehabilitation

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Dementia, Vascular

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Dementia; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Timea Hodics, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Darrel W Cleere, MPH

CONTACT

(713)-441-3770; dwcleere@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Self-report measures will be not blinded, assessors will be blinded to treatment phase (SOC or telerehabilitation)
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 4, 2024
• Study Start: December 14, 2024
• Primary Completion (Estimated): March 14, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)