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Search / Trial NCT06289569

Home Tele Rehabilitation Therapy for Vascular Dementia

Launched by THE METHODIST HOSPITAL RESEARCH INSTITUTE · Feb 28, 2024

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help people who have had a stroke and may also have vascular dementia, which is a type of memory loss linked to blood flow issues in the brain. The researchers want to see if a home tele-rehabilitation program—where patients can do therapy from home using technology—can make it easier for patients and reduce the strain on their caregivers. The trial is not yet recruiting participants, but it aims to include adults aged 18 and older who have had a stroke at least six months ago and have some movement in their affected arm.

To participate, individuals must be able to follow simple instructions and have a way to attend evaluation sessions. They should also be living in the community and able to use a therapy system with minimal help. However, those with severe mental health issues, certain physical limitations, or serious medical problems that could make rehabilitation unsafe will not be eligible. Participants can expect to engage in a program designed to help improve their upper body movement and overall well-being while getting support for their caregivers.

Gender

ALL

Eligibility criteria

  • 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

About The Methodist Hospital Research Institute

The Methodist Hospital Research Institute (MHRI) is a leading clinical research organization dedicated to advancing medical science through innovative research and collaboration. Affiliated with the Methodist Hospital system, MHRI focuses on a broad spectrum of clinical trials, aiming to translate cutting-edge discoveries into effective therapies that enhance patient care. With a commitment to ethical standards and patient safety, the institute fosters partnerships between researchers, clinicians, and industry stakeholders, driving progress in fields such as cancer, cardiology, neurology, and more. Through its robust infrastructure and multidisciplinary approach, MHRI strives to improve health outcomes and contribute to the advancement of medical knowledge.

Locations

Houston, Texas, United States

Patients applied

0 patients applied

Trial Officials

Timea Hodics, MD

Principal Investigator

The Methodist Hospital Research Institute

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported