Evaluation of a self-administered transcutaneous electrical stimulation concept for the treatment of spasticity: a randomized placebo-controlled trial.

Background: Spasticity is a common consequence of injury to the central nervous system negatively affecting patient's everyday activities. Treatment mainly consists of training and different drugs, often with side effects. There is a need for treatment options that can be performed by the patient in their home environment.

Aim: The objective of this study was to assess the effectiveness of an assistive technology (AT), Mollii®, a garment with integrated electrodes for multifocal transcutaneous electrical stimulation intended for self-treatment of spasticity, in study participants with spasticity due to stroke or CP.

Design: The study was a randomized, controlled, double-blind study with a cross-over design.

Setting: Participants were recruited from two rehabilitation clinics. Treatments were performed in participants' homes and all follow-ups were performed in the two rehabilitation clinics.

Population: Thirty-one participants were included in the study and 27 completed the study. Four participants discontinued the study. Two declined participation before baseline and two withdrew due to problems handling the garment.

Methods: Participants used the AT with and without electrical stimulation (active/non-active period) for six weeks each, followed by six weeks without treatment. Goal Attainment Scaling (GAS), change in mobility, arm-hand ability, spasticity and pain were measured at baseline and after 6, 12 and 18 weeks.

Results: Fifteen of the 27 participants fulfilled the treatment protocol in terms of recommended use. Deviations were frequent. No statistically significant differences in outcome were found between the active and the non-active treatment periods. During the active period, an improvement was seen in the 10-meter comfortable gait test, time and steps. An improvement was seen in both the active and non-active periods for the GAS.

Conclusions: Compliance was low, partly due to deviations related to the garment, complicating the interpretation of the results. Further research should focus on identifying the target population and concomitant rehabilitation strategies.

Clinical Rehabilitation Impact: The evaluated concept of multifocal transcutaneous electrical stimulation (TES) represents an interesting addition to the existing repertoire of treatments to alleviate muscle spasticity. The evaluated concept allows TES to be self-administered by the patient in the home environment. A more elaborate design of training activities directly related to patient's own rehabilitation goals is recommended and may increase the value of the evaluated concept.