Evaluation of Multifocal Transcutaneous Electrical Stimulation for Self-treatment Among Children With Cerebral Palsy

Not Applicable

Completed

• Conditions: Spastic Cerebral Palsy
• Interventions: Other: Mollii ®

• Registration Number: NCT04078321
• Lead Sponsor: Sormland County Council, Sweden

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 Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2019-08-23
• Study First Submitted QC: 2019-09-02
• Study First Posted: 2019-09-06
• Status Verified: 2021-01
• Primary Completion: 2021-08-01
• Study Completion: 2021-09-01
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single case design	Mollii ®	Single case studies

Primary Outcome Measures

Name	Time	Method
Modified Ashworth Scale	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 Outcome Measures

Name	Time	Method
Faces pain scale 0-5	four weeks	Measures of pain recorded daily in a diary. Rating 0 indicating
Timed Up and Go (time)	four weeks	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).
Two questions of sleeling quality, three answer options provided	four weeks	Measures of sleep recorded daily in a diary
Box and block test (number of blocks moved in one minute)	four weeks	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.
Adherence measured by days using the garment during the intervention	four weeks	The participant will report in a diary each day the garment is used and the diary also provide the possibility to add a comment.
Level of Sitting Scale (score 1-8)	four weeks	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)

Trial Locations

Locations (1)

Marina Arkkukangas; 🇸🇪 Eskilstuna, Sweden