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| Name | Class |
|---|---|
| University of Borås | UNKNOWN |
| University Hospital, Linkoeping | OTHER |
| Sodra Alvsborgs Hospital | OTHER |
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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;
Secondary objectives are;
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multifocal TENS | Experimental | Multifocal TENS given in the garment Mollii® (Elektrodress) 1 hour every second day together with individualized training exercises. The steering unit counts down 60 minutes visible for the patient |
|
| Sham treatment | Sham Comparator | Use of the garment Mollii® (Elektrodress) but without the electrical stimulation combined with the individualized training exercises. The steering unit counts down 60 minutes visible for the patient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multifocal TENS garment (Mollii®) | Device | Multifocal transcutaneous electrical stimulation incorporated into a whole-body garment in combination with training |
|
| Measure | Description | Time Frame |
|---|---|---|
| Goal attainment scaling (GAS) | 1 to 3 goals are defined and evaluated using the original GAS scale by Kiresuk | 12 weeks |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Health related Quality of Life/QALY | SF-36 and EQ-VAS | Baseline, week 6, 12, 18, 52 |
| Self reported pain and spasticity | Numeric rating scale (NRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D009128 | Muscle Spasticity |
| D020521 | Stroke |
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
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|
| Baseline, week 6, 12, 18, 52 |
| Muscle hypertonicity (Spasticity) | Modified Ashworth scale (0-5) | Baseline, week 6, 12, 18, 52 |
| Range of Motion | Goniometer | Baseline, week 6, 12, 18, 52 |
| 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 |
| Goal Attainment Scaling (GAS) | 1 to 3 goals are defined and evaluated using the original GAS scale by Kiresuk | 52 weeks |
| 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 |
| 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 |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001925 | Brain Damage, Chronic |