Efficacy and Cost-effectiveness of Spasticity Treatment With Multifocal TENS

Stroke Clinical Trial

Official title: Evaluation of Efficacy and Cost-effectiveness of Spasticity Treatment With Multifocal Transcutaneous Electrical Stimulation, Through a Garment With built-in Electrodes in Combination With Training.

Status Completed

Clinical Trial Summary

Spasticity is a common consequence of injury to the central nervous system and can be a major problem in motor function and everyday activities. A method for treating spasticity that applies low-amplitude electrical stimulation through a garment with built-in electrodes, Mollii® (Elektrodress), has been developed. The garment is to be used in combination with individualized training and the stimulation is mainly given to antagonists of spastic muscles.

The general objective of this study is to evaluate the efficacy of and costs associated with the Mollii® treatment of spasticity due to stroke or cerebral palsy.

Primary objectives are;

• to study whether treatment with the Mollii® improves function and activity

• to evaluate the cost-effectiveness of the treatment, from both a health-care perspective and a societal perspective.

Secondary objectives are;

• to study whether there are differences in treatment effect between the stroke and the Cerebral Palsy groups in a subgroup-analysis

• to assess compliance with treatment

• to report any adverse effects.

Clinical Trial Description

This study is designed as a double-blinded, randomized, cross-over trial (RCT). This part of the study takes 12 weeks (6 weeks of active treatment and 6 weeks of non-active treatment) and is followed by a wash-out period of 6 weeks. An uncontrolled,open phase starts after week 18, where patients are followed one year after inclusion.

30 participants with spasticity due to Stroke and Cerebral Palsy will be included.

Two centers are recruiting participants and are collecting data.

Outcome measures are chosen to reflect the different dimensions in the International Classification of Functioning, Disability and Health (ICF) and patient reported outcome measures (PROM). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Spasticity
• Stroke

• NCT number: NCT02261142
• Study type: Interventional
• Source: Linkoeping University
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Completion date: February 2015