Spastic Cerebral PalsyNCT04322825
Mollii - Personalized Suit for Treatment of Spasticity, GFMCS 3-5
A study testing TENS incorporated into the Mollii suit in people with Spastic Cerebral Palsy, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The objective of this study was to examine the effect on spasticity and function of multifocal transcutaneous electrical stimulation incorporated in a 2-piece (Mollii) suit. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- TENS incorporated into the Mollii suit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2017to 1 Jul 2019
- 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
- No healthy volunteers
- Child, Adult
Who may be able to join
- cerebral palsy with spastic disease, GMFCS 3-5.
Who cannot join
- other disorders affecting the sensorimotor functions without spasticity,
- implanted electric medical devices,
- BMI>35
- other severe concomitant diseases such as cancer, cardiovascular, inflammatory, psychiatric disease, medical dysregulated epilepsy or hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mollii - Personalized Suit for Treatment of Spasticity, GFMCS3-5
The objective of this study was to examine the effect on spasticity and function of multifocal transcutaneous electrical stimulation incorporated in a 2-piece (Mollii) suit.
Read the detailed description
In this prospective cohort study, the participants (children with predominantly spastic CP, GFMCS 3-5) wore the suit for 1 hour every second day for 24 weeks. The investigators evaluated level of spasticity using the modified Ashworth scale (MAS) and other related measures before initiation, after 4, 12, and 24 weeks. Two motor related smart goals were defined and evaluated by the goal attainment scale (GAS). GMFM-66 and posture and postural ability scale (PPAS) were performed.
- Conditions
- Spastic Cerebral Palsy
- Being tested
- TENS incorporated into the Mollii suit
- Keywords
- Mollii suit;, Goal Attainment Scale;, Reciprocal inhibition;, modified ashworth scale,, trans cutaneous electric stimulation, TENS, Spasticity reduction,
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENS incorporated into the Mollii suitDevice
trans cutaneous electric stimulation,
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | 24 weeks of TENS Receives: Device: TENS incorporated into the Mollii suit |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified ashworth scale
spasticity evaluation from 0 (best) to 4 (worst) in modified ashworth scale
Measured: 24 weeks
Secondary outcomes (1)
Goal Attainment Scale
smart goals from -2 (worst) to +2 (best)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start1 Jun 2017
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
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
- prospective cohort study
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eurostars
- Responsible party
- Principal investigator, christian wong, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322825
- Sponsor's protocol ID
- H-17004467
- Status last verified
- Jan 2023
- First submitted
- 1 Nov 2019
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we are not permitted to share these data due to gpdr ruels
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mollii - Personalized Suit for Treatment of Spasticity, GFMCS3-5
- ClinicalTrials.gov ID
- NCT04322825
- Acronym / sponsor ID
- H-17004467
- Conditions
- Spastic Cerebral Palsy
- Keywords
- Mollii suit;, Goal Attainment Scale;, Reciprocal inhibition;, modified ashworth scale,, trans cutaneous electric stimulation, TENS, Spasticity reduction,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Eurostars
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 26 Mar 2020 (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 objective of this study was to examine the effect on spasticity and function of multifocal transcutaneous electrical stimulation incorporated in a 2-piece (Mollii) suit.
Detailed description
In this prospective cohort study, the participants (children with predominantly spastic CP, GFMCS 3-5) wore the suit for 1 hour every second day for 24 weeks. The investigators evaluated level of spasticity using the modified Ashworth scale (MAS) and other related measures before initiation, after 4, 12, and 24 weeks. Two motor related smart goals were defined and evaluated by the goal attainment scale (GAS). GMFM-66 and posture and postural ability scale (PPAS) were performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Device: TENS incorporated into the Mollii suit24 weeks of TENS |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- cerebral palsy with spastic disease, GMFCS 3-5.
Key exclusion criteria (4 listed)
- other disorders affecting the sensorimotor functions without spasticity,
- implanted electric medical devices,
- BMI>35
- other severe concomitant diseases such as cancer, cardiovascular, inflammatory, psychiatric disease, medical dysregulated epilepsy or hypertension.
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 |
|---|---|---|
| TENS incorporated into the Mollii suittrans cutaneous electric stimulation, | Device | intervention |
Primary outcome
modified ashworth scale
Time frame: 24 weeks
spasticity evaluation from 0 (best) to 4 (worst) in modified ashworth scale
1 secondary outcome
Goal Attainment Scale
Time frame: 24 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 6 Jan 2023.
- Individual participant dataSharing planned: No. we are not permitted to share these data due to gpdr ruels
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS incorporated into the Mollii suit in people with Spastic Cerebral Palsy, run by Hvidovre University Hospital at 1 site in Denmark.
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 1 inclusion and 4 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 6 Jan 2023. 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 Denmark. 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: 24 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 6 Jan 2023.