Recruiting

Tele Rehabilitation

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT06289569

Conditions

Dementia, Vascular

Stroke Sequelae

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Home telerehabilitation therapy

Study Details

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

Study ID

NCT06289569

Start date

Dec 14, 2024

Status verified date

Feb, 2026

Completion date

Apr 1, 2028

Anticipated

Primary completion date

Mar 14, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tele Rehabilitation

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.

Interventions

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.

Primary outcome measure

  • Burden Scale for Family Caregivers [ Time Frame: 3-4 months ]
  • Adverse events [ Time Frame: 3-4 months ]

Central Contacts and Locations

Central contacts

Darrel W Cleere, MPH

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

Locations

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Timea Hodics, MD

713-763-9589tmhodics@houstonmethodist.org

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2026-03-02.