Efficacy and Cost-effectiveness of Spasticity Treatment With Multifocal TENS

NCT ID: NCT02261142

Last Updated: 2015-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-02-28

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).

Conditions

Spasticity; Stroke; Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Multifocal TENS garment (Mollii®)

Intervention Type: DEVICE

Multifocal transcutaneous electrical stimulation incorporated into a whole-body garment in combination with training

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

Group Type: SHAM_COMPARATOR

Multifocal TENS garment (Mollii®)

Intervention Type: DEVICE

Multifocal transcutaneous electrical stimulation incorporated into a whole-body garment in combination with training

Interventions

Multifocal TENS garment (Mollii®)

Multifocal transcutaneous electrical stimulation incorporated into a whole-body garment in combination with training

Intervention Type: DEVICE

Other Intervention Names

Mollii®; Elektrodress; Swedish patent:SE534365.C2

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Borås

UNKNOWN

Sponsor Role: collaborator

University Hospital, Linkoeping

OTHER

Sponsor Role: collaborator

Sodra Alvsborgs Hospital

OTHER

Sponsor Role: collaborator

Linkoeping University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Per Ertzgaard

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

LIU-ED2013

Identifier Type: -

Identifier Source: org_study_id