Background and Purpose-The purpose of this study was to assess the efficacy of neuromuscular stimulation in enhancing the upper extremity motor and functional recovery of acute stroke survivors. Methods-Forty-six stroke survivors admitted to an inpatient rehabilitation unit were randomly assigned to receive either neuromuscular stimulation or placebo. Twenty-eight subjects completed the study. The treatment group received surface neuromuscular stimulation to produce wrist and finger extension exercises. The control group received placebo stimulation over the paretic forearm. All subjects were treated 1 hour per day, for a total of 15 sessions. Outcomes were assessed in a blinded manner with the upper extremity component of the Fugl-Meyer Motor Assessment and the self-care component of the Functional Independence Measure at pretreatment, after treatment, and at 4 and 12 weeks after treatment. Results-The treatment subjects and control subjects had comparable baseline characteristics. Parametric analyses revealed significantly greater gains in Fugl-Meyer scores for the treatment group after treatment (13.1 versus 6.5; Pϭ0.05), at 4 weeks after treatment (17.9 versus 9.7; Pϭ0.05), and at 12 weeks after treatment (20.6 versus 11.2; Pϭ0.06).Functional Independence Measure scores were not different between groups at any of the time periods (PϾ0.10). Conclusions-Data suggest that neuromuscular stimulation enhances the upper extremity motor recovery of acute stroke survivors. However, the sample size in this study was too small to detect any significant effect of neuromuscular stimulation on self-care function. (Stroke. 1998;29:975-979.)
The results support the use of the SULCS to measure upper limb capacity in patients who are less than 2 years poststroke with moderate to severe hemiplegia.
Background
Multi-site studies in stroke rehabilitation are important for determining whether a technology and/or treatment can be successfully administered by sites other than the originating site and with similar positive outcomes. This study is the first multi-site clinical trial of a novel intervention for post-stroke upper limb rehabilitation called contralaterally controlled functional electrical stimulation (CCFES). Previous pilot and single-site studies showed positive effects of CCFES on upper limb impairment and hand dexterity in stroke survivors. The main purpose of this study is to confirm and demonstrate the efficacy of CCFES in a larger group of most likely responders across multiple clinical sites.
Methods
Up to 129 stroke survivors with moderate to severe upper extremity hemiparesis at 4 clinical trial sites will be randomized to CCFES, cyclic neuromuscular electrical stimulation (cNMES), or task-oriented-training (TOT). Participants will receive 12 weeks of group-specific therapy. Blinded assessments of upper limb impairment and activity limitation, quality of life, and neurophysiology will be used to compare outcomes at baseline, after treatment, and up to 6 months post-treatment. The primary endpoint is change in dexterity from baseline to 6 months post-treatment.
Discussion
Loss of hand function following stroke is a major rehabilitation problem affecting millions of people per year globally. More effective rehabilitation therapies are needed to restore hand function in these individuals. This study will determine whether CCFES therapy produces greater improvements in upper extremity function than cNMES or TOT, and will begin to elucidate the different mechanisms underlying each of the three treatments. This multi-site study is a critical step in advancing a novel method of rehabilitation toward clinical translation and widespread dissemination.
Trial registration
ClinicalTrials.gov NCT03574623. Registered prior to first enrollment; July 2, 2018.
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