Spastic Cerebral PalsyNCT04078321
Evaluation of Multifocal Transcutaneous Electrical Stimulation for Self-treatment Among Children With Cerebral Palsy
A study testing Mollii ® in people with Spastic Cerebral Palsy, run by Sormland County Council, Sweden at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- Mollii ®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2019to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The effect and use of the garment will be evaluated in single - case studies using ABAB design.
- Conditions
- Spastic Cerebral Palsy
- Being tested
- Mollii ®
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Single case design | Experimental | Single case studies Receives: Other: Mollii ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: four weeks
Secondary outcomes (6)
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).
Measured: four weeks
Faces pain scale 0-5
Measures of pain recorded daily in a diary. Rating 0 indicating
Measured: four weeks
Two questions of sleeling quality, three answer options provided
Measures of sleep recorded daily in a diary
Measured: four weeks
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.
Measured: four weeks
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)
Measured: four weeks
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.
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 May 2019
- Primary completion1 Aug 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single case studies
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sormland County Council, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marina Arkkukangas, PhD, Study director, Research and Development in Sörmland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078321
- Sponsor's protocol ID
- Mollii
- Status last verified
- Jan 2021
- First submitted
- 23 Aug 2019
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Multifocal Transcutaneous Electrical Stimulation for Self-treatment Among Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04078321
- Acronym / sponsor ID
- Mollii
- Conditions
- Spastic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Sormland County Council, SwedenUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single case studies
| Arm | Type | Receives |
|---|---|---|
| Single case design | Experimental | Other: Mollii ®Single case studies |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Single case design |
Primary outcome
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 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.
6 secondary outcomes
Timed Up and Go (time)
Time frame: four weeks
Faces pain scale 0-5
Time frame: four weeks
Two questions of sleeling quality, three answer options provided
Time frame: four weeks
Adherence measured by days using the garment during the intervention
Time frame: four weeks
Level of Sitting Scale (score 1-8)
Time frame: four weeks
Box and block test (number of blocks moved in one minute)
Time frame: four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Arkkukangas, PhD study director
Research and Development in Sörmland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mollii ® in people with Spastic Cerebral Palsy, run by Sormland County Council, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (time frame: four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.