Home Tele Rehabilitation Therapy for Vascular Dementia

Stroke Sequelae Clinical Trial

Official title:

Home Tele Rehabilitation Therapy for Vascular Dementia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06289569
• Other study ID #: PRO00037243
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 14, 2024
• Est. completion date: April 1, 2026

Study information

• Verified date: February 2024
• Source: The Methodist Hospital Research Institute
• Contact: Meyyammai Narayanan, MPH
• Phone: 908-227-7275
• Email: mknarayanan[@]houstoethodist.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: April 1, 2026
• Est. primary completion date: March 14, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Dementia, Vascular
• Stroke Sequelae

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Methodist Hospital Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exercise log	Exercise log to record amount of use.	3-4 months
Other	Stroke Impact Scale	Stroke Impact Scale (SIS) self-report questionnaire. Scale ranges 0-100, higher score means better recovery.	3-4 months
Primary	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
Primary	Adverse events	Prospective record of adverse events including dropouts	3-4 months
Secondary	Fugl-Meyer Upper extremity assessment	The uFM test measures both proximal and distal upper extremity movements. Intratester and intertester reliability and validity of the Fugl-Meyer scale is well established in stroke patients. A score ranges 0-66, higher scores are better.	3-4 months
Secondary	Wolf Motor Function Test (WMFT)	The WMFT is a time-based method to evaluate upper extremity performance of 17 tasks while providing insight into joint-specific and total limb movements. Lower time scores mean better motor function.	3-4 months