Efficacy and Cost-effectiveness of Spasticity Treatment With Multifocal TENS

Stroke Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02261142
• Other study ID #: LIU-ED2013
• Status: Completed
• Phase: N/A
• First received: October 1, 2014
• Last updated: July 10, 2015
• Start date: September 2013
• Est. completion date: February 2015

Study information

• Verified date: July 2015
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: Swedish Data Inspection Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Spasticity
• Stroke

Intervention

Device:
• Multifocal TENS garment (Mollii®)
Multifocal transcutaneous electrical stimulation incorporated into a whole-body garment in combination with training

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Linkoeping University	Sodra Alvsborgs Hospital, University Hospital, Linkoeping, University of Borås

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Goal attainment scaling (GAS)	1 to 3 goals are defined and evaluated using the original GAS scale by Kiresuk	12 weeks	No
Primary	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	No
Primary	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	No
Secondary	Health related Quality of Life/QALY	SF-36 and EQ-VAS	Baseline, week 6, 12, 18, 52	No
Secondary	Self reported pain and spasticity	Numeric rating scale (NRS)	Baseline, week 6, 12, 18, 52	No
Secondary	Muscle hypertonicity (Spasticity)	Modified Ashworth scale (0-5)	Baseline, week 6, 12, 18, 52	No
Secondary	Range of Motion	Goniometer	Baseline, week 6, 12, 18, 52	No
Secondary	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	No
Secondary	Goal Attainment Scaling (GAS)	1 to 3 goals are defined and evaluated using the original GAS scale by Kiresuk	52 weeks	No
Secondary	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	No
Secondary	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	No