Telerehabilitation In The Home After Stroke
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of California, Los Angeles
About this trial
The purpose of this research study is to evaluate whether telerehabilitation targeting arm movement, when added to usual care, improves arm function and reduces global disability after stroke, compared to usual care alone.
Patients with arm weakness due to stroke that happened in the past 90-150 days will be randomized into one of two groups: \[1\] TR and usual care; \[2\] usual care only (no TR), but people in the usual care group will be offered TR once the study is done. TR consists of 70 minutes/day of activities targeting arm function, 6 days a week for 6 weeks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-80 years at the time of randomization
The index stroke was radiologically verified, due to ischemia or intracerebral hemorrhage (ICH), and had time of onset 120±30 days prior to randomization
The stroke caused upper extremity deficits as defined by Action Research Arm Test score 18-44 (out of 57) at Baseline Visit 1
Box & Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit 1
Disqualifiers
A major, active, coexistent neurological, psychiatric, or medical disease that reduces the likelihood that a subject will be able to comply with all study procedures
Unable or unwilling to perform study procedures/therapy, or expectation of noncompliance with study procedures/therapy, or expectation that subject cannot participate in all study visits
A diagnosis (apart from the index stroke) that substantially affects paretic arm function
Severe depression, defined as Geriatric Depression Scale Score >10/15 at Baseline Visit 1
Trial design
Design model
Parallel
Treatments tested in this trial
Telerehabilitation
DeviceThe telerehabilitation system will deliver rehabilitation treatment sessions via a secured internet-connected computer. TR sessions will be a combination of games, exercises, stroke education, assessments, in addition to videoconferencing with therapists to discuss progress, issues, goals, and changes to the treatment plan.
Treatment groups
202 Participants
are divided into 2 treatment groupsGroup A: Usual CareNo intervention 0 interventions
Group B: Telerehabilitation + Usual CareExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Action Research Arm Test (ARAT) Score from Baseline to 2 Months
The ARAT scale measures arm function using a scale that runs from 0 to 57 points, with higher numbers reflecting better arm function.
Time frame
2 monthsSecondary outcomes
1
Change in modified Rankin Scale (mRS) Score from Baseline to 2 Months
The mRS scale measures global function using a scale that runs from 0 to 6 points, with lower numbers reflecting better global function.
Time frame
2 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Los Angeles
Lead sponsor
Moss Rehabilitation Research Institute
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov