Contralaterally controlled functional electrical stimulation video game therapy for hand rehabilitation after stroke: a randomized controlled trial.

The study was slightly underpowered because 13 of 52 participants withdrew or did not complete treatment, leaving 39 in the primary analysis against a target of 46. Home-session adherence was significantly lower in the video game group (65% versus 87%), so the two groups did not receive the same effective dose, and the null result may partly reflect this imbalance rather than a true absence of benefit. The video game component was introduced only after participants were comfortable with CCFES at home, with an average delay of 1.9 weeks (range 1 to 5), reducing the total video game dose and partially blurring the difference between groups. Five participants in the video game group continued doing CCFES hand opening exercises for the full 12 weeks instead of transitioning fully to the games, creating a partial cross-over. The study was single-site, and the mean time since stroke was 4.5 years, so results apply to a chronic, moderately to severely affected population and may not generalize to subacute or milder cases. The study was not powered for the secondary analyses of time since stroke and impairment severity.

Funded by the U.S. National Institutes of Health (extramural). The CCFES stimulator was custom-designed and manufactured by PDI Works, Inc. No explicit conflicts-of-interest statement appears in the provided text.

Do not read the small within-group score improvements as evidence that this treatment meaningfully restores hand function. The authors state these changes were not clinically relevant, and the between-group difference on the primary outcome was null. The video game group also had significantly lower home-session adherence (65% versus 87%), so the null result may partly reflect a lower effective dose rather than a true absence of benefit.