Efficacy and Cost-effectiveness of Spasticity Treatment With Multifocal TENS

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.

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Cerebral Palsy; Spasticity
• Intervention / Treatment: Device: Multifocal TENS garment (Mollii®)

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multifocal TENS; 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	Device: Multifocal TENS garment (Mollii®); Multifocal transcutaneous electrical stimulation incorporated into a whole-body garment in combination with training; Other Names: Mollii®; Elektrodress; Swedish patent:SE534365.C2
Sham Comparator: Sham treatment; 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	Device: Multifocal TENS garment (Mollii®); Multifocal transcutaneous electrical stimulation incorporated into a whole-body garment in combination with training; Other Names: Mollii®; Elektrodress; Swedish patent:SE534365.C2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Goal attainment scaling (GAS)	1 to 3 goals are defined and evaluated using the original GAS scale by Kiresuk	12 weeks
Arm-hand ability (ARAT + WMFT tasks 1&2)	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	12 weeks
Mobility	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)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related Quality of Life/QALY	SF-36 and EQ-VAS	Baseline, week 6, 12, 18, 52
Self reported pain and spasticity	Numeric rating scale (NRS)	Baseline, week 6, 12, 18, 52
Muscle hypertonicity (Spasticity)	Modified Ashworth scale (0-5)	Baseline, week 6, 12, 18, 52
Range of Motion	Goniometer	Baseline, week 6, 12, 18, 52
Costs	Costs directly related to intervention Baseline, week 6, 12, 18 Costs from a societal perspective at baseline and week 52	Baseline, week 6, 12, 18, 52
Goal Attainment Scaling (GAS)	1 to 3 goals are defined and evaluated using the original GAS scale by Kiresuk	52 weeks
Arm-hand ability (ARAT + WMFT tasks 1&2)	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	52 weeks
Mobility	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)	52 weeks

Collaborators and Investigators

• Sponsor: Linkoeping University
• Collaborators: University Hospital, Linkoeping; Sodra Alvsborgs Hospital; University of Boras

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: October 1, 2014
• First Submitted That Met QC Criteria: October 9, 2014
• First Posted (Estimate): October 10, 2014

Study Record Updates

• Last Update Posted (Estimate): July 13, 2015
• Last Update Submitted That Met QC Criteria: July 10, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Cerebral Palsy; Muscle Spasticity
• Other Study ID Numbers: LIU-ED2013