Efficacy and Cost-effectiveness of Spasticity Treatment With Multifocal TENS

Not Applicable

Completed

• Conditions: Spasticity; Cerebral Palsy; Stroke
• Interventions: Device: Multifocal TENS garment (Mollii®)

• Registration Number: NCT02261142
• Lead Sponsor: Linkoeping University

Brief 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.

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).

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-10-01
• Study First Submitted QC: 2014-10-09
• Study First Posted: 2014-10-10
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-10
• Last Update Posted: 2015-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Spasticity due to stroke or Cerebral Palsy
• Have some preserved walking ability, with or without walking aids
• Be able to understand the treatment and instruments/interviews used
• For stroke participants, two years should have elapsed since their injury/insult

Exclusion Criteria

• Electronic devices
• Ventriculoperitoneal shunt
• Arrhythmia
• Hearth infarction or unstable angina pectoris
• Symptomatic hyper- or hypotonia
• Cancer under treatment
• Unstable psychiatric disease
• Lung disease, affecting daily life
• Unstable epileptic disease
• Orthopedic surgery last year
• Obesity with BMI > 35
• Infectious disease with longstanding treatment
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Multifocal TENS	Multifocal TENS garment (Mollii®)	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
Sham treatment	Multifocal TENS garment (Mollii®)	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

Primary Outcome Measures

Name	Time	Method
Goal attainment scaling (GAS)	12 weeks	1 to 3 goals are defined and evaluated using the original GAS scale by Kiresuk
Arm-hand ability (ARAT + WMFT tasks 1&2)	12 weeks	Action Research Arm Test (ARAT)measuring grasp, grip, pinch and gross movement and this is complemented by Wolf Motor Function Test (WMFT) tasks 1 and 2 measuring active shoulder abduction
Mobility	12 weeks	10 meter walking test, divided into comfortable gait test (CGT) and fast gait test (FGT). Outcome is velocity, cadence and stride length.; Timed Up \& Go (TUG)

Secondary Outcome Measures

Name	Time	Method
Health related Quality of Life/QALY	Baseline, week 6, 12, 18, 52	SF-36 and EQ-VAS
Goal Attainment Scaling (GAS)	52 weeks	1 to 3 goals are defined and evaluated using the original GAS scale by Kiresuk
Self reported pain and spasticity	Baseline, week 6, 12, 18, 52	Numeric rating scale (NRS)
Muscle hypertonicity (Spasticity)	Baseline, week 6, 12, 18, 52	Modified Ashworth scale (0-5)
Range of Motion	Baseline, week 6, 12, 18, 52	Goniometer
Mobility	52 weeks	10 meter walking test, divided into comfortable gait test (CGT) and fast gait test (FGT). Outcome is velocity, cadence and stride length.; Timed Up \& Go (TUG)
Costs	Baseline, week 6, 12, 18, 52	Costs directly related to intervention Baseline, week 6, 12, 18 Costs from a societal perspective at baseline and week 52
Arm-hand ability (ARAT + WMFT tasks 1&2)	52 weeks	Action Research Arm Test (ARAT)measuring grasp, grip, pinch and gross movement and this is complemented by Wolf Motor Function Test (WMFT) tasks 1 and 2 measuring active shoulder abduction