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

Sormland County Council, Sweden

Status: Completed

Conditions: Spastic Cerebral Palsy

Treatments: Other: Mollii ®

Study type: Interventional

Funder types: Other

Identifiers

NCT04078321

Mollii

Details and patient eligibility

About

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.

Full description

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

Enrollment: 8 patients

Sex: All

Ages: 4 to 18 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Single case design

Experimental group

Description:

Single case studies

Treatment:

Other: Mollii ®