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

NCT ID: NCT04078321

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2021-09-01

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.

Conditions

Spastic Cerebral Palsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single case design

Single case studies

Group Type: EXPERIMENTAL

Mollii ®

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sormland County Council, Sweden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marina Arkkukangas, PhD

Role: STUDY_DIRECTOR

Research and Development in Sörmland

Locations

Marina Arkkukangas

Eskilstuna, , Sweden

Countries

Sweden

Other Identifiers

Mollii

Identifier Type: -

Identifier Source: org_study_id