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

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.

Study Overview

• Status: Completed
• Conditions: Spastic Cerebral Palsy
• Intervention / Treatment: Other: Mollii ®

Detailed Description

The effect and use of the garment will be evaluated in single - case studies using ABAB design.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Eskilstuna, Sweden, 63220
    • Marina Arkkukangas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single case design; Single case studies

Other: Mollii ®; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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; 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; More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved; Considerable increase in muscle tone, passive movement difficult; Affected part(s) rigid in flexion or extension The mesures will be perfomed three times each week for four weeks.	four weeks

Secondary Outcome Measures

Outcome Measure	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).	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

Collaborators and Investigators

• Sponsor: Sormland County Council, Sweden
• Investigators: Study Director: Marina Arkkukangas, PhD, Research and Development in Sörmland

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: September 2, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: Mollii

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No