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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
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.
Marina Arkkukangas
Eskilstuna, Sweden
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 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+= Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension The mesures will be perfomed three times each week for four weeks.
Time frame: four weeks
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).
Time frame: four weeks
Faces pain scale 0-5
Measures of pain recorded daily in a diary. Rating 0 indicating
Time frame: four weeks
Two questions of sleeling quality, three answer options provided
Measures of sleep recorded daily in a diary
Time frame: four weeks
Adherence measured by days using the garment during the intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The participant will report in a diary each day the garment is used and the diary also provide the possibility to add a comment.
Time frame: 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)
Time frame: 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.
Time frame: four weeks