search
Back to results

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

Primary Purpose

Spastic Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Mollii ®
Sponsored by
Sormland County Council, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Cerebral Palsy

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Marina Arkkukangas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single case design

Arm Description

Single case studies

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
Faces pain scale 0-5
Measures of pain recorded daily in a diary. Rating 0 indicating
Two questions of sleeling quality, three answer options provided
Measures of sleep recorded daily in a diary
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.
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)
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.

Full Information

First Posted
August 23, 2019
Last Updated
October 25, 2022
Sponsor
Sormland County Council, Sweden
search

1. Study Identification

Unique Protocol Identification Number
NCT04078321
Brief Title
Evaluation of Multifocal Transcutaneous Electrical Stimulation for Self-treatment Among Children With Cerebral Palsy
Official Title
Evaluation of Multifocal Transcutaneous Electrical Stimulation for Self-treatment Among Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sormland County Council, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single case studies
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single case design
Arm Type
Experimental
Arm Description
Single case studies
Intervention Type
Other
Intervention Name(s)
Mollii ®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modified Ashworth Scale
Description
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.
Time Frame
four weeks
Secondary Outcome Measure Information:
Title
Timed Up and Go (time)
Description
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
Title
Faces pain scale 0-5
Description
Measures of pain recorded daily in a diary. Rating 0 indicating
Time Frame
four weeks
Title
Two questions of sleeling quality, three answer options provided
Description
Measures of sleep recorded daily in a diary
Time Frame
four weeks
Title
Adherence measured by days using the garment during the intervention
Description
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
Title
Level of Sitting Scale (score 1-8)
Description
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
Title
Box and block test (number of blocks moved in one minute)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marina Arkkukangas, PhD
Organizational Affiliation
Research and Development in Sörmland
Official's Role
Study Director
Facility Information:
Facility Name
Marina Arkkukangas
City
Eskilstuna
ZIP/Postal Code
63220
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs