NCT04078321

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

October 26, 2022

Status Verified

January 1, 2021

Enrollment Period

2.3 years

First QC Date

August 23, 2019

Last Update Submit

October 25, 2022

Conditions

Spastic Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • 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 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.

    four weeks

Secondary Outcomes (6)

  • Timed Up and Go (time)

    four weeks

  • Faces pain scale 0-5

    four weeks

  • Two questions of sleeling quality, three answer options provided

    four weeks

  • Adherence measured by days using the garment during the intervention

    four weeks

  • Level of Sitting Scale (score 1-8)

    four weeks

  • +1 more secondary outcomes

Study Arms (1)

Single case design

EXPERIMENTAL

Single case studies

Other: Mollii ®

Interventions

Mollii ®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.

Single case design

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marina Arkkukangas

Eskilstuna, 63220, Sweden

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Marina Arkkukangas, PhD

    Research and Development in Sörmland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single case studies
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2019

First Posted

September 6, 2019

Study Start

May 1, 2019

Primary Completion

August 1, 2021

Study Completion

September 1, 2021

Last Updated

October 26, 2022

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)