Home Tele Rehabilitation Therapy for Vascular Dementia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-110
SponsorThe Methodist Hospital Research Institute
About this trial
To determine whether the home telerehabilitation therapy is feasible and lessens caregiver burden in chronic stroke patients with and without vascular dementia (VaD)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Home telerehabilitation therapy
Other interventionOccupational 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.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Tele RehabilitationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Burden Scale for Family Caregivers
Burden Scale for Family Caregivers BSFC-s\[8\] Subjective caregiver burden 10-item short version of the questionnaire.
Time frame
3-4 months2
Adverse events
Prospective record of adverse events including dropouts
Time frame
3-4 monthsSecondary outcomes
1
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.
Time frame
3-4 months2
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.
Time frame
3-4 monthsOther outcomes
1
Exercise log
Exercise log to record amount of use.
Time frame
3-4 months2
Stroke Impact Scale
Stroke Impact Scale (SIS) self-report questionnaire. Scale ranges 0-100, higher score means better recovery.
Time frame
3-4 monthsSponsors and contacts
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Source ClinicalTrials.gov