Contralaterally controlled functional electrical stimulation for upper extremity hemiplegia: an early-phase randomized clinical trial in subacute stroke patients

Abstract

Background: Contralaterally controlled functional electrical stimulation (CCFES) is an experimental treatment intended to improve hand function after stroke.

Objective: To compare the effects of 6 weeks of CCFES versus cyclic neuromuscular electrical stimulation (NMES) on upper extremity impairment and activity limitation in patients ≤6 months poststroke.

Methods: Twenty-one participants were randomized to CCFES or cyclic NMES. Treatment for both groups consisted of daily stimulation-assisted repetitive hand-opening exercise at home plus twice-weekly lab sessions of functional task practice. Assessments were made at pretreatment and posttreatment and at 1 month and 3 months posttreatment. They included maximum voluntary finger extension angle, finger movement tracking error, upper extremity Fugl-Meyer score, Box and Blocks test, and Arm Motor Abilities test. Treatment effects were estimated using a 2-factor repeated measures analysis of variance with the value of the baseline measure as a covariate.

Results: Seventeen patients completed the treatment phase (9 CCFES, 8 cyclic NMES). At all posttreatment time points, CCFES produced larger improvements than cyclic NMES on every outcome measure. Maximum voluntary finger extension showed the largest treatment effect, with a mean group difference across the posttreatment time points of 28° more finger extension for CCFES.

Conclusions: The results favor CCFES over cyclic NMES though the small sample size limits the statistical power of the study. The effect size estimates from this study will be used to power a larger trial.

Figures

Figure 1

Contralaterally controlled functional electrical stimulation system. Volitional opening of the unaffected hand produces a proportional intensity of stimulation to the paretic hand extensors. The system enables patients with hemiplegia to practice tasks. (Illustration by Ellen Howat. ©2011 Cleveland FES Center, Cleveland, OH.).

Figure 2

Flow of participants through the study.

Figure 3

Maximum voluntary finger extension angle means and standard errors. Baseline value is the mean across subjects from both groups. Values at EOT, 1m, and 3m are baseline-adjusted scores. Abbreviations: EOT, end of treatment; 1m, 1-month follow-up; 3m, 3-month follow-up.

Figure 4

Distribution of maximum voluntary finger extension angle changes for cyclic NMES (top) and CCFES (bottom) participants.