Clinical trial NCT02261142: Efficacy and Cost-effectiveness of Spasticity Treatment With Multifocal TENS
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spasticity
Stroke
Cerebral Palsy
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: University of Borås
name: University Hospital, Linkoeping
name: Sodra Alvsborgs Hospital
First posted: 2014-10-10
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Goal attainment scaling (GAS)
timeFrame: 12 weeks
measure: Arm-hand ability (ARAT + WMFT tasks 1&2)
timeFrame: 12 weeks
measure: Mobility
timeFrame: 12 weeks
Secondary outcomes:
measure: Health related Quality of Life/QALY
timeFrame: Baseline, week 6, 12, 18, 52
measure: Self reported pain and spasticity
timeFrame: Baseline, week 6, 12, 18, 52
measure: Muscle hypertonicity (Spasticity)
timeFrame: Baseline, week 6, 12, 18, 52
measure: Range of Motion
timeFrame: Baseline, week 6, 12, 18, 52
measure: Costs
timeFrame: Baseline, week 6, 12, 18, 52
measure: Goal Attainment Scaling (GAS)
timeFrame: 52 weeks
measure: Arm-hand ability (ARAT + WMFT tasks 1&2)
timeFrame: 52 weeks
measure: Mobility
timeFrame: 52 weeks
Other outcomes:
Locations:
Study officials:
References: