Evaluation of Multifocal Transcutaneous Electrical Stimulation for Self-treatment Among Children With Cerebral Palsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 8
- Locations
- 2
- Primary Endpoint
- Modified Ashworth Scale
Study Overview
Brief Summary
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.
Detailed Description
The effect and use of the garment will be evaluated in single - case studies using ABAB design.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Cerebral palsy diagnosis, with spasticity as the main symptom
- •Established GMFCS, levels 1-5
- •MACS level, levels 1-5
- •Included in the CPUP * national quality register
- •Person should be between 4 years and up to 18 years
- •Secured communication to and from person
- •Neing able to convey pain or discomfort.
Exclusion Criteria
- •No treatment received within next three months before participation with botulinum toxin treatment to reduce spasticity.
- •The patient may not have a shunt or other medical pump that may be affected by the electrical stimulation provided by the garment.
Outcomes
Primary Outcomes
Modified Ashworth Scale
Time Frame: four weeks
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.
Secondary Outcomes
- Faces pain scale 0-5(four weeks)
- Timed Up and Go (time)(four weeks)
- Two questions of sleeling quality, three answer options provided(four weeks)
- Box and block test (number of blocks moved in one minute)(four weeks)
- Adherence measured by days using the garment during the intervention(four weeks)
- Level of Sitting Scale (score 1-8)(four weeks)