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Efficacy and Cost-effectiveness of Spasticity Treatment With Multifocal TENS

NCT02261142 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2015-07-13

No results posted yet for this study

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.

Conditions

  • Spasticity
  • Stroke
  • Cerebral Palsy

Interventions

DEVICE

Multifocal TENS garment (Mollii®)

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

Sponsors & Collaborators

  • University of Borås

    collaborator UNKNOWN

  • University Hospital, Linkoeping

    collaborator OTHER

  • Sodra Alvsborgs Hospital

    collaborator OTHER

  • Linkoeping University

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-02-28
Completion
2015-02-28

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02261142 on ClinicalTrials.gov