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NCT Number: NCT02261142

Efficacy and Cost-effectiveness of Spasticity Treatment With Multifocal TENS

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.

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Key information

Conditions

Spasticity Brain Damage, Chronic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Palsy Cerebrovascular Disorders Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multifocal TENS garment (Mollii®)

Device

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

Other names: Mollii®, Elektrodress, Swedish patent:SE534365.C2

Primary outcomes

  1. Goal attainment scaling (GAS)

    Time frame: 12 weeks

    1 to 3 goals are defined and evaluated using the original GAS scale by Kiresuk

  2. Arm-hand ability (ARAT + WMFT tasks 1&2)

    Time frame: 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

  3. Mobility

    Time frame: 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 outcomes

  1. Health related Quality of Life/QALY

    Time frame: Baseline, week 6, 12, 18, 52

    SF-36 and EQ-VAS

  2. Self reported pain and spasticity

    Time frame: Baseline, week 6, 12, 18, 52

    Numeric rating scale (NRS)

  3. Muscle hypertonicity (Spasticity)

    Time frame: Baseline, week 6, 12, 18, 52

    Modified Ashworth scale (0-5)

  4. Range of Motion

    Time frame: Baseline, week 6, 12, 18, 52

    Goniometer

  5. Costs

    Time frame: 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

  6. Goal Attainment Scaling (GAS)

    Time frame: 52 weeks

    1 to 3 goals are defined and evaluated using the original GAS scale by Kiresuk

  7. Arm-hand ability (ARAT + WMFT tasks 1&2)

    Time frame: 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

  8. Mobility

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Collaborators

  • Sodra Alvsborgs Hospital
  • University Hospital, Linkoeping
  • University of Borås

Registry information

Official study title

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.

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 10, 2014
Registry last updated
Jul 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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