Clinical trial NCT06289569: Home Tele Rehabilitation Therapy for Vascular Dementia
Official title: Home Tele Rehabilitation Therapy for Vascular Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia, Vascular
Stroke Sequelae
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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)

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.

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

Primary outcomes:
measure: Burden Scale for Family Caregivers
timeFrame: 3-4 months
measure: Adverse events
timeFrame: 3-4 months
Secondary outcomes:
measure: Fugl-Meyer Upper extremity assessment
timeFrame: 3-4 months
measure: Wolf Motor Function Test (WMFT)
timeFrame: 3-4 months
Other outcomes:
measure: Exercise log
timeFrame: 3-4 months
measure: Stroke Impact Scale
timeFrame: 3-4 months
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Timea Hodics, MD
role: PRINCIPAL_INVESTIGATOR
References: