Efficacy and Cost-effectiveness of Spasticity Treatment With Multifocal TENS

Completed

Phase N/A Results N/A

Trial Description

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.

Detailed 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).

Conditions

Interventions

  • Multifocal TENS garment (Mollii®) Device
    Other Names: Mollii®; Elektrodress; Swedish patent:SE534365.C2
    Intervention Desc: Multifocal transcutaneous electrical stimulation incorporated into a whole-body garment in combination with training
    ARM 1: Kind: Experimental
    Label: Multifocal TENS
    Description: Multifocal TENS given in the garment Mollii® (Elektrodress) 1 hour every second day together with individualized training exercises. The steering unit counts down 60 minutes visible for the patient
    ARM 2: Kind: Experimental
    Label: Sham treatment
    Description: Use of the garment Mollii® (Elektrodress) but without the electrical stimulation combined with the individualized training exercises. The steering unit counts down 60 minutes visible for the patient

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Goal attainment scaling (GAS) 12 weeks No
Primary Arm-hand ability (ARAT + WMFT tasks 1&2) 12 weeks No
Primary Mobility 12 weeks No
Secondary Health related Quality of Life/QALY Baseline, week 6, 12, 18, 52 No
Secondary Self reported pain and spasticity Baseline, week 6, 12, 18, 52 No
Secondary Muscle hypertonicity (Spasticity) Baseline, week 6, 12, 18, 52 No
Secondary Range of Motion Baseline, week 6, 12, 18, 52 No
Secondary Costs Baseline, week 6, 12, 18, 52 No

Sponsors