Stroke Clinical Trial
Official title:
Telerehabilitation in the Home Versus Therapy In-Clinic for Patients With Stroke An Assessor-blind, Randomized, Non-inferiority Trial
The current study will test the effectiveness of a novel home-based telehealth system designed to improve motor recovery and patient education after stroke. A total of 124 subjects (the number may be larger depending on the rate of subject dropout) with arm motor deficits 4-36 weeks after a stroke due to ischemia or to intracerebral hemorrhage will be randomized to receive 6 weeks of intensive arm motor therapy (a) in a traditional in-clinic setting or (b) via in-home telerehabilitation (rehabilitation services delivered to the subject's home via an internet-connected computer). The intensity, duration, and frequency of this therapy will be identical across the two groups, with subjects in both treatment arms receiving 36 sessions (18 supervised and 18 unsupervised), 80 minutes each (including a 10 minute break), over 6 weeks. The primary endpoint is within-subject change in the arm motor Fugl-Meyer (FM) score from the Baseline Visit to 30 Day Follow-Up Visit. Arm motor status is the focus here because it is commonly affected by stroke, is of central importance to many human functions, and is strongly linked to disability and well being after stroke.
Substantial evidence indicates that occupational and physical therapy improves outcomes after
stroke, and that larger doses are associated with superior outcomes. However, many patients
receive suboptimal doses of therapy for reasons that include cost, access, and difficulty
with travel. This problem is likely to increase with time given the aging of the population
and the increased rate with which patients survive stroke. Telehealth, defined as the
delivery of health-related services and information via telecommunication technologies, has
enormous potential to address this unmet need.
The current study will test the effectiveness of a novel home-based telehealth system
designed to improve motor recovery and patient education after stroke. A total of 124
subjects (the number may be larger depending on the rate of subject dropout) with arm motor
deficits 4-36 weeks after a stroke due to ischemia or to intracerebral hemorrhage will be
randomized to receive 6 weeks of intensive arm motor therapy (a) in a traditional in-clinic
setting or (b) via in-home telerehabilitation (rehabilitation services delivered to the
subject's home via an internet-connected computer). The intensity, duration, and frequency of
this therapy will be identical across the two groups, with subjects in both treatment arms
receiving 36 sessions (18 supervised and 18 unsupervised), 80 minutes each (including a 10
minute break), over 6 weeks. The primary endpoint is within-subject change in the arm motor
Fugl-Meyer (FM) score from the Baseline Visit to 30 Day Follow-Up Visit. Arm motor status is
the focus here because it is commonly affected by stroke, is of central importance to many
human functions, and is strongly linked to disability and well being after stroke.
Telerehabilitation will be evaluated using an assessor-blind, randomized, non-inferiority
study design. This study seeks to establish comparable efficacy between the two treatment
arms based upon a non-inferiority margin of 2.05 points on the arm motor Fugl-Meyer scale.
Key study features include enrollment of a diverse stroke population, standardized and
blinded outcomes assessment, a standardized treatment protocol, covariate-adaptive
randomization, and use of an active comparator that is matched for duration, frequency, and
intensity of therapy. The FDA has determined that this investigation is a non-significant
risk device study.
A minimum of 5 clinical sites will participate in this study. Each clinical site will conduct
all testing and treatment at a single central site, although each clinical site is encouraged
to recruit subjects from their referral hospitals. At the central study site, an Assessment
Therapist will perform all study testing, blinded to treatment assignment (the subject by
necessity is not blinded), while a Treatment Therapist will provide in-clinic therapy as well
as direct home-based telerehabilitation. Potential enrollees may be identified through any of
several routes, for example, during the acute stroke admission at the clinical site or a
referral hospital, during inpatient rehabilitation at the clinical site or a referral
hospital, or through other means of community-based recruitment. Study conduct will be highly
standardized, including selecting therapy content, delivering therapy, and testing.
The current study aims to critically evaluate the utility of a telehealth approach to motor
therapy and stroke education. Telehealth has enormous potential to address unmet needs in the
growing population of stroke survivors.
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