Cerebral Palsy, Spasticity, Stroke
Conditions
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).
Interventions
DEVICEMultifocal TENS garment (Mollii®)
Multifocal transcutaneous electrical stimulation incorporated into a whole-body garment in combination with training
Sponsors
University of Borås
University Hospital, Linkoeping
Sodra Alvsborgs Hospital
Linkoeping University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Goal attainment scaling (GAS) | 12 weeks | 1 to 3 goals are defined and evaluated using the original GAS scale by Kiresuk |
| Arm-hand ability (ARAT + WMFT tasks 1&2) | 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 |
| Mobility | 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
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion | Baseline, week 6, 12, 18, 52 | Goniometer |
| Costs | 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 |
| Health related Quality of Life/QALY | Baseline, week 6, 12, 18, 52 | SF-36 and EQ-VAS |
| Arm-hand ability (ARAT + WMFT tasks 1&2) | 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 |
| Mobility | 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) |
| Goal Attainment Scaling (GAS) | 52 weeks | 1 to 3 goals are defined and evaluated using the original GAS scale by Kiresuk |
| Self reported pain and spasticity | Baseline, week 6, 12, 18, 52 | Numeric rating scale (NRS) |
| Muscle hypertonicity (Spasticity) | Baseline, week 6, 12, 18, 52 | Modified Ashworth scale (0-5) |
Outcome results
None listed