A medical device that delivers pulses of electrical stimulation to lower leg muscles does not seem to accelerate recovery among people who experience long-term walking impairments after a stroke.
That’s the conclusion of a clinical trial run at 23 hospitals across Japan with operational support from the Translational Research Center for Medical Innovation (TRI) in Kobe. It challenges the conventional wisdom about devices known as functional electrical stimulation (FES) systems.
FES devices are not without merit. Stroke patients who have difficulty lifting the front part of their foot, a condition known as foot drop, can still use the device as a walking aid, since it helps improve gait quality when worn. Take the device off, however, and the new clinical data indicate that the device is no better than conventional rehabilitation therapy at speeding recovery in the long term.
“This multi-center prospective randomized controlled trial denied our hypothesis that four-week gait training with the device would improve the walking distance and speed compared with gait training without device,” says Kenji Hachisuka, director of the Kyushu Rosai Hospital’s Moji Medical Center in Kitakyushu, who led the study. “This was a negative study,” he adds.
In the trial, 119 patients with persistent foot drop after a stroke underwent eight hours of self-directed training over a month, followed by a little over four hours of physical therapist-assisted training. Half the patients used a FES device, and half did not.
Both groups experienced about the same overall improvement in walking ability. The only significant difference proved to be in the patients’ own assessments of their recovery, with device users reporting greater self-perceived progress than non-users.
“The findings suggest that while clinicians may continue to prescribe the device for chronic stroke patients with foot drop as an alternative to ankle-foot orthosis, they should not use the device to gain more neurophysiological recovery,” says Hachisuka.
Unless, that is, patients use the FES device in the first months after a stroke. In another TRI-sponsored trial, a team led by Shuji Matsumoto from the Nippon Medical School in Tokyo randomly assigned people who had recently suffered stroke-induced foot drop to undergo a standard rehabilitation program, with or without intensive FES. “Earlier use of FES and more amount of FES therapy may increase the influence of this therapy on functional outcomes,” Hachisuka says.
- Hachisuka, K., Ochi, M., Kikuchi, T. & Saeki, S. Clinical effectiveness of peroneal nerve functional electrical stimulation in chronic stroke patients with hemiplegia (PLEASURE): A multicentre, prospective, randomised controlled trial. Clinical Rehabilitation advance online publication (October 2020)| article
About the Researcher
Kenji Hachisuka, Professor Emeritus, University of Occupational and Environmental Health
Kenji Hachisuka is a professor emeritus of the Department of Rehabilitation Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan and has been the director of the Moji Medical Center, Japan Organization of Occupational Health and Safety since 2014. His clinical practice is in stroke, traumatic brain injury, and polio, and his research interests are robot-assisted training and driving rehabilitation.