Background and Purpose—
For
stroke rehabilitation, task-specific training in animal models and
human rehabilitation trials is considered important to modulate
neuroplasticity, promote motor learning, and functional recovery.
Little
is known about what constitutes an effective dosage of therapy.
(So every stroke patient is a one person guinea pig in an unregistered clinical trial. Did you sign a consent form for that?)
Methods—
This
is a parallel group, 4 arms, single-blind, phase IIb, randomized
controlled trial of 4 dosages of arm therapy delivered in an outpatient
setting chronically after stroke. Participants were randomized into
groups that varied in duration of scheduled therapy (ie, 0, 15, 30, or
60 hours). Forty-one participants completed the study. Planned primary
analyses used linear mixed effects regression to model changes from
baseline to postintervention in the Motor Activity Log-Quality of
Movement rating and the Wolf Motor Function Test time score over 3 weeks
of training as a function of therapy dosage.
Results—
We
observed a dose response for the Motor Activity Log-Quality of
Movement: the model that included dose and dose by week interaction
significantly better fit the data than the model that included week only
(log-likelihood test,
P=0.0026). In addition, the greater the
dosage of training, the greater the change in Motor Activity Log-Quality
of Movement, with the dose by week interaction parameter equal to
0.0045 (
P=0.0016; 95% CI, 0.0018–0.0071). Over the 3 weeks of
therapy, there was a gain of 0.92 in Motor Activity Log-Quality of
Movement for the 60-hour group compared to the 0-hour group. There was
no dose response for the Wolf Motor Function Test.
Conclusions—
For
mild-to-moderately impaired stroke survivors, the dosage of
patient-centered, task-specific practice systematically influences the
gain in quality of arm use but not functional capacity. We caution that
we may have been underpowered for the functional capacity outcome. These
findings highlight the importance of recovery outcomes that capture arm
use in the natural environment.
Clinical Trial Registration—
URL:
https://www.clinicaltrials.gov. Unique identifier: NCT01749358.
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