Chronic Stroke Survivors With Plegic Hand Clinical Trial
Official title:
Constraint-Induced Therapy Modified for Rehabilitating Arm Function in Stroke Survivors w/Plegic Hands
The purpose of this study is to compare modified CI therapy for strokes survivors with very limited function to an alternative package of conventional physical rehabilitation techniques
Constraint-Induced Movement therapy or CI therapy is a rehabilitation method, based on
behavioral neuroscience studies of deafferented monkeys, that has been shown in controlled
studies to produce large improvements in real-world upper-extremity use in individuals with
chronic stroke. Up till now, survivors of stroke with plegic hands have been excluded from
CI therapy protocols, whether on a research or clinical basis. Such individuals are
estimated to make up at least 35% of the population with chronic stroke with residual motor
deficit. Furthermore, there are no other interventions for such individuals that have
controlled evidence of efficacy for increasing real-world function. Thus, these stroke
survivors represent a large number of healthcare consumers with limited treatment options.
We recently completed a pilot study of a modified form of CI therapy for stroke survivors
with plegic hands, and obtained surprisingly positive findings. Six individuals were
enrolled who had a flicker of active movement at the elbow and at the wrist or a finger and
30° of active range of motion at the shoulder. Participants received three weeks of CI
therapy, combined with other modes of therapy, for six hours per day. The treatment package
included tone management/movement facilitation, training of more-impaired arm use using
shaping, functional task practice, restraint of the less-impaired arm in the laboratory and
at home as indicated, and a package of behavioral methods for transferring gains from the
laboratory to the home situation. As a group, the patients showed a large improvement in
more-impaired arm use in daily life after treatment (Motor Activity Log or MAL; p's < 05,
Effect Size > 1.5). Improvements in more-impaired arm motor ability, as measured by scores
on a laboratory motor performance test (graded Wolf Motor Function Test; gWMFT) and
standardized clinical examination (Fugl-Meyer), were also substantial (p's < .05).
Based on these initial findings, we propose a randomized, controlled clinical trial to
rigorously test the efficacy of this modification of CI therapy for rehabilitating arm
function in chronic stroke patients with severe upper-extremity impairment. To this end, 40
survivors of stroke with plegic hands will be randomly assigned to receive the intervention
described above or a placebo control procedure of the same duration. Control participants
will receive either 1) tone management, EMG biofeedback and other procedures in alternating
blocks for 6 hr daily for 15 consecutive weekdays or 2) usual & customary care. Measures of
arm motor ability (gWMFT; Fugl-Meyer), arm use in daily life (MAL, accelerometry), and
quality of life (Stroke Impact Scale) will be administered to all participants before and
after treatment and at long-term. If the modified CI therapy participants shows larger
improvements in more-impaired arm function than the control group participants, this will
suggest it is an efficacious treatment and raise hopes of additional recovery for a large
group of healthcare consumers with limited treatment options.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment