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The main purpose with this study is to investigate the effectiveness of a garment with integrated electrodes for multifocal transcutaneous electrical stimulation intended for treatment of spasticity in children with cerebral palsy.
The effect and use of the garment will be evaluated in single - case studies using ABAB design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single case design | Experimental | Single case studies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mollii ® | Other | The garment claims to have a 48 hours lasting effect of an hour of treatment. The garment should be worn for at least 1 hour every other day. All participants receive individually tailored garments and individually tailored appropriate training towards specific goals set in connection to study start. The garment is used in the home environment and the family is responsible for documentation of use in a diary. Measurements is performed following an ABAB design for four weeks. Measurement performed at 12 occasions during the four weeks are; spasticity, physical function, pain, sleep and adherence. Standardized protocols for the intervention are provided to involved physical therapists. |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Ashworth Scale | Measures of spasticity at 12 Occasions using the Modified Ashworth Scale. Measures include both upper and lower limbs. Scores are rated by:: 0= No increase in muscle tone
The mesures will be perfomed three times each week for four weeks. | four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Timed Up and Go (time) | Measures of physical function at 12 Occasions, the mesures will be perfomed three times each week for four weeks. Instructions: The patient should sit on a standard armchair, placing his/her back against the chair and resting his/her arms chair's arms. Any assistive device used for walking should be nearby. Regular footwear and customary walking aids should be used. The patient should walk to a line that is 3 meters (9.8 feet) away, turn around at the line, walk back to the chair, and sit down. The test ends when the patient's buttocks touch the seat. Patients should be instructed to use a comfortable and safe walking speed. A stopwatch should be used to time the test (in seconds). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marina Arkkukangas, PhD | Research and Development in Sörmland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marina Arkkukangas | Eskilstuna | 63220 | Sweden |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 19, 2025 | |
| Reset | Oct 9, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 19, 2025 | Oct 9, 2025 |
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Single case studies
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| four weeks |
| Faces pain scale 0-5 | Measures of pain recorded daily in a diary. Rating 0 indicating | four weeks |
| Two questions of sleeling quality, three answer options provided | Measures of sleep recorded daily in a diary | four weeks |
| Adherence measured by days using the garment during the intervention | The participant will report in a diary each day the garment is used and the diary also provide the possibility to add a comment. | four weeks |
| Level of Sitting Scale (score 1-8) | Measures of physical function at 12 Occasions, the mesures will be perfomed three times each week for four weeks. The participant will be placed in sitting position. Score 1 indicating lowest score on sitting function (highest need of support) and 8 indicating highest function on sitting function (lowest need of support) | four weeks |
| Box and block test (number of blocks moved in one minute) | Measures of physical function at 12 Occasions, the mesures will be perfomed three times each week for four weeks.The score is the number of blocks carried from one compartment to the other in one minute. Score each hand separately. After testing, the examiner should count the blocks If a patient transports two or more blocks at the same time, this should be noted and the number subtracted from the total. | four weeks |