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Completed

NCT Number: NCT04078321

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.

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Key information

Conditions

Spastic Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marina Arkkukangas

Eskilstuna, 63220, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Modified Ashworth Scale

    Time frame: four weeks

    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 outcomes

  1. Timed Up and Go (time)

    Time frame: four weeks

    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).

  2. Faces pain scale 0-5

    Time frame: four weeks

    Measures of pain recorded daily in a diary. Rating 0 indicating

  3. Two questions of sleeling quality, three answer options provided

    Time frame: four weeks

    Measures of sleep recorded daily in a diary

  4. Adherence measured by days using the garment during the intervention

    Time frame: four weeks

    The participant will report in a diary each day the garment is used and the diary also provide the possibility to add a comment.

  5. Level of Sitting Scale (score 1-8)

    Time frame: four weeks

    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)

  6. Box and block test (number of blocks moved in one minute)

    Time frame: four weeks

    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.

Sponsors and collaborators

Lead sponsor

Sormland County Council, Sweden

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 6, 2019
Registry last updated
Oct 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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