Cerebral PalsyNCT04715334
Can Transcutaneous Electrical Stimulation Garment Improve Gait in Children With Cerebral Palsy?
A study testing Mollii suit in people with Cerebral Palsy and Spasticity, Muscle, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
Living with cerebral palsy is challenging for the child as well as the family charged with their care and support needs. Many families seek effective and sustainable interventions to improve gait of their children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Cerebral Palsy, Spasticity, Muscle
- What is being tested?
- Mollii suit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- 8 Dec 2020to 31 Dec 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
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 4-18
- GMFCS level I to III
- Spasticity as the dominant motor feature
- Children agree to wear the Mollii suit as per procedures and consent to the study
- Parents/carers agree to assist their child to wear the Mollii suit as per procedures
- Medical practitioner's approval
Who cannot join
- Individuals with electrical implanted stimulatory device
- Individuals with medical devices that are affected by magnets, such as programmable shunts.
- Individuals with cardiovascular diseases, infectious diseases, malignance (cancer), fever, pregnancy, rashes or skin problems.
- Individuals who have had Botulinum toxin done 6 months prior intervention or soft tissue release surgery done 6 months prior intervention.
- Individuals who have had change in oral medication for spasticity 1 month prior intervention.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
KKWCH
Singapore, 229899
Zhi Min Ng, MBBS, ng.zhi.min@singhealth.com.sg
About this study
Official title: Effectiveness in Improving Gait and Feasibility of a Transcutaneous Electrical Stimulation Garment in Children With Cerebral Palsy in Singapore
Living with cerebral palsy is challenging for the child as well as the family charged with their care and support needs. Many families seek effective and sustainable interventions to improve gait of their children with cerebral palsy. The Mollii suit is a non-invasive therapeutic technology using electrical stimulation in the form of whole-body garment with multiple electrodes individually programmed to stimulate selected muscles. This study aims to examine if the Mollii suit improve gait in ambulant children with cerebral palsy and if the Mollii suit is acceptable and tolerable to children with cerebral palsy. We will recruit up to 20 children with cerebral palsy. This study will evaluate change in gait and function following a four-week intervention period using a protocol of wearing the Mollii suit at home for one hour every day for four weeks using instrumented 3-dimensional gait analysis and objective standardised assessment tools.
Read the detailed description
BACKGROUND
Living with cerebral palsy is challenging for the child as well as the family charged with their care and support needs. Many families seek effective and sustainable interventions to improve gait of their children with cerebral palsy. An intervention that could be used in the home setting, assessed periodically by health care professionals of a tertiary pediatric centre, that has a benefit on gait and motor function in children with cerebral palsy might be feasible to families in the local Singapore healthcare setting. The Mollii suit is a non-invasive therapeutic technology using electrical stimulation in the form of whole-body garment with multiple electrodes individually programmed to stimulate selected muscles. Based on small preliminary studies, it is suggested that the Mollii suit improves mobility, gait, function and quality of life.
OBJECTIVES
This study aims to examine the effectiveness of the Mollii suit in improving gait in children with cerebral palsy. It also aims to determine the value of the Mollii suit by evaluating the acceptability, tolerance and compliance of the Mollii suit in children with cerebral palsy.
METHODOLOGY
This is a single-centre study that will recruit up to 20 children with cerebral palsy, GMFCS I-III. This study will evaluate change in gait and function following a four-week intervention period using a protocol of wearing the Mollii suit at home for one hour every day for four weeks using instrumented 3-dimensional gait analysis and objective standardised assessment tools. Primary outcome is improvement in gait, measured using the Gait Profile Score, Gait Deviation index, gait speed and cadence. Secondary outcomes include changes in functional assessments such as Functional Assessment Questionnaire (FAQ), Gross Motor Function Measure (GMFM), 10 metre walk test, Goal attainment Scale (GAS) and quality of life measures.
- Conditions
- Cerebral Palsy, Spasticity, Muscle
- Being tested
- Mollii suit
- Keywords
- gait, electrical stimulation
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mollii suitDevice
The Mollii suit is a new technology of electrical stimulation in the form of whole-body garment with multiple electrodes individually programmed to stimulate the selected muscles. Based on preliminary studies, it is suggested that the Mollii suit improves spasticity. Recent studies also proposed that it improves mobility, gait, function and quality of life. However, these studies are based on qualitative and subjective measures.
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Experimental | The intervention is the Mollii suit which is fitted and programmed by the Mollii suit distributor, Inerventions and will be administered by trained physiotherapists from KKH. Participants will be involved in the Intervention phase of the study for 4 weeks with treatment duration of 60 min/ session every day. Receives: Device: Mollii suit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gait Profile Score (GPS)
GPS is a single index measure that summarises the overall deviation of kinematic gait data relative to normative data. It ranges from 0 to 30, the higher the score, the more severe the gait. We will measure change in GPS pre and post intervention.
Measured: 1 month post intervention
Change in Gait Profile Score (GPS)
GPS is a single index measure that summarises the overall deviation of kinematic gait data relative to normative data. It ranges from 0 to 30, the higher the score, the more severe the gait. We will measure change in GPS pre and post intervention.
Measured: 2 months post intervention
Change in Gait deviation index (GDI)
GDI provides a numerical value that expresses overall gait pathology (ranging from 0 to 100, where 100 indicates the absence of gait pathology). The higher the GDI, the better the result.
Measured: 1 month post intervention
Change in Gait deviation index (GDI)
GDI provides a numerical value that expresses overall gait pathology (ranging from 0 to 100, where 100 indicates the absence of gait pathology). The higher the GDI, the better the result.
Measured: 2 months post intervention
Change in Gait speed (metre/sec)
The faster the gait speed, the better the result.
Measured: 1 month post intervention
Change in Gait speed (metre/sec)
The faster the gait speed, the better the result.
Measured: 2 months post intervention
Change in Cadence (steps/ minute)
The higher the cadence, the better the result.
Measured: 1 month post intervention
Change in Cadence (steps/ minute)
The higher the cadence, the better the result.
Measured: 2 months post intervention
Secondary outcomes (12)
Change in Gross motor function measure (GMFM)
GMFM is an assessment tool designed and evaluated to measure changes in gross motor function with intervention in children with cerebral palsy. The closer the score to 100%, the better the score.
Measured: 1 month post intervention
Change in Gross motor function measure (GMFM)
GMFM is an assessment tool designed and evaluated to measure changes in gross motor function with intervention in children with cerebral palsy. The closer the score to 100%, the better the score.
Measured: 2 months post intervention
Change in Functional Assessment Questionnaire (FAQ)
FAQ is a 10 point scale (with 10 being most able) which was designed specifically to be used as an outcome measure in individuals with physical disability. The higher the score the better the result.
Measured: 1 month post intervention
Change in Functional Assessment Questionnaire (FAQ)
FAQ is a 10 point scale (with 10 being most able) which was designed specifically to be used as an outcome measure in individuals with physical disability. The higher the score the better the result.
Measured: 2 months post intervention
Change in EQ5D
EQ5D is a standardised measure of health status to provide a simple, generic measure of health for clinical and economic appraisal. The descriptive system comprises 5 dimensions. Score ranges from 5 to 15. The higher score the poorer the result. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale 0-100. The higher the score, the better the self-rated health.
Measured: 1 month post intervention
Change in EQ5D
EQ5D is a standardised measure of health status to provide a simple, generic measure of health for clinical and economic appraisal. The descriptive system comprises 5 dimensions. Score ranges from 5 to 15. The higher score the poorer the result. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale 0-100. The higher the score, the better the self-rated health.
Measured: 2months post intervention
Change in ICF-CY ratings
The WHO International Classification of Functioning, Disability and Health, Children \& Youth version (ICF-CY) is a measure to grade function of activities of daily living (ADLs). Few ICF-CY categories have been selected and graded based on the frequency, intrusiveness or severity of the specific impairment. In each category, rating ranges from 0 to 4. The higher the rating, the worse the outcome.
Measured: 1 month post intervention
Change in ICF-CY ratings
The WHO International Classification of Functioning, Disability and Health, Children \& Youth version (ICF-CY) is a measure to grade function of activities of daily living (ADLs). Few ICF-CY categories have been selected and graded based on the frequency, intrusiveness or severity of the specific impairment. In each category, rating ranges from 0 to 4. The higher the rating, the worse the outcome.
Measured: 2 months post intervention
Compliance
Compliance is measured using log of use of mollii suit.
Measured: 1 month post intervention
Compliance
Compliance is measured using log of use of mollii suit.
Measured: 2 months post intervention
Acceptance
Acceptance to the mollii suit is evaluated qualitatively using an open-ended questionnaire filled up by patient and caregivers
Measured: 1 month post intervention
Acceptance
Acceptance to the mollii suit is evaluated qualitatively using an open-ended questionnaire filled up by patient and caregivers
Measured: 2 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start8 Dec 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- 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
- pre and post intervention comparison
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- Inerventions AB
- Responsible party
- Principal investigator, Ng Zhi Min, KK Women's and Children's Hospital
- Investigators
- Zhi Min Ng, MBBS, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715334
- Sponsor's protocol ID
- 2020/2150
- Status last verified
- Jan 2021
- First submitted
- 7 Dec 2020
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mills PB, Dossa F. Transcutaneous Electrical Nerve Stimulation for Management of Limb Spasticity: A Systematic Review. Am J Phys Med Rehabil. 2016 Apr;95(4):309-18. doi: 10.1097/PHM.0000000000000437.
PubMed 26829077Wright PA, Durham S, Ewins DJ, Swain ID. Neuromuscular electrical stimulation for children with cerebral palsy: a review. Arch Dis Child. 2012 Apr;97(4):364-71. doi: 10.1136/archdischild-2011-300437.
PubMed 22447997
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness in Improving Gait and Feasibility of a Transcutaneous Electrical Stimulation Garment in Children With Cerebral Palsy in Singapore
- ClinicalTrials.gov ID
- NCT04715334
- Acronym / sponsor ID
- 2020/2150
- Conditions
- Cerebral Palsy, Spasticity, Muscle
- Keywords
- gait, electrical stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- Inerventions AB
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 20 Jan 2021 (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.
Living with cerebral palsy is challenging for the child as well as the family charged with their care and support needs. Many families seek effective and sustainable interventions to improve gait of their children with cerebral palsy. The Mollii suit is a non-invasive therapeutic technology using electrical stimulation in the form of whole-body garment with multiple electrodes individually programmed to stimulate selected muscles. This study aims to examine if the Mollii suit improve gait in ambulant children with cerebral palsy and if the Mollii suit is acceptable and tolerable to children with cerebral palsy. We will recruit up to 20 children with cerebral palsy. This study will evaluate change in gait and function following a four-week intervention period using a protocol of wearing the Mollii suit at home for one hour every day for four weeks using instrumented 3-dimensional gait analysis and objective standardised assessment tools.
Detailed description
BACKGROUND
Living with cerebral palsy is challenging for the child as well as the family charged with their care and support needs. Many families seek effective and sustainable interventions to improve gait of their children with cerebral palsy. An intervention that could be used in the home setting, assessed periodically by health care professionals of a tertiary pediatric centre, that has a benefit on gait and motor function in children with cerebral palsy might be feasible to families in the local Singapore healthcare setting. The Mollii suit is a non-invasive therapeutic technology using electrical stimulation in the form of whole-body garment with multiple electrodes individually programmed to stimulate selected muscles. Based on small preliminary studies, it is suggested that the Mollii suit improves mobility, gait, function and quality of life.
OBJECTIVES
This study aims to examine the effectiveness of the Mollii suit in improving gait in children with cerebral palsy. It also aims to determine the value of the Mollii suit by evaluating the acceptability, tolerance and compliance of the Mollii suit in children with cerebral palsy.
METHODOLOGY
This is a single-centre study that will recruit up to 20 children with cerebral palsy, GMFCS I-III. This study will evaluate change in gait and function following a four-week intervention period using a protocol of wearing the Mollii suit at home for one hour every day for four weeks using instrumented 3-dimensional gait analysis and objective standardised assessment tools. Primary outcome is improvement in gait, measured using the Gait Profile Score, Gait Deviation index, gait speed and cadence. Secondary outcomes include changes in functional assessments such as Functional Assessment Questionnaire (FAQ), Gross Motor Function Measure (GMFM), 10 metre walk test, Goal attainment Scale (GAS) and quality of life measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pre and post intervention comparison
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Experimental | Device: Mollii suitThe intervention is the Mollii suit which is fitted and programmed by the Mollii suit distributor, Inerventions and will be administered by trained physiotherapists from KKH. Participants will be involved in the Intervention phase of the study for 4 weeks with treatment duration of 60 min/ session every day. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Aged 4-18
- GMFCS level I to III
- Spasticity as the dominant motor feature
- Children agree to wear the Mollii suit as per procedures and consent to the study
- Parents/carers agree to assist their child to wear the Mollii suit as per procedures
Key exclusion criteria (5 listed)
- Individuals with electrical implanted stimulatory device
- Individuals with medical devices that are affected by magnets, such as programmable shunts.
- Individuals with cardiovascular diseases, infectious diseases, malignance (cancer), fever, pregnancy, rashes or skin problems.
- Individuals who have had Botulinum toxin done 6 months prior intervention or soft tissue release surgery done 6 months prior intervention.
- Individuals who have had change in oral medication for spasticity 1 month prior intervention.
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 suitThe Mollii suit is a new technology of electrical stimulation in the form of whole-body garment with multiple electrodes individually programmed to stimulate the selected muscles. Based on preliminary studies, it is suggested that the Mollii suit improves spasticity. Recent studies also proposed that it improves mobility, gait, function and quality of life. However, these studies are based on qualitative and subjective measures. | Device | Single arm study |
Primary outcome
Change in Gait Profile Score (GPS)
Time frame: 1 month post intervention
GPS is a single index measure that summarises the overall deviation of kinematic gait data relative to normative data. It ranges from 0 to 30, the higher the score, the more severe the gait. We will measure change in GPS pre and post intervention.
Change in Gait Profile Score (GPS)
Time frame: 2 months post intervention
GPS is a single index measure that summarises the overall deviation of kinematic gait data relative to normative data. It ranges from 0 to 30, the higher the score, the more severe the gait. We will measure change in GPS pre and post intervention.
Change in Gait deviation index (GDI)
Time frame: 1 month post intervention
GDI provides a numerical value that expresses overall gait pathology (ranging from 0 to 100, where 100 indicates the absence of gait pathology). The higher the GDI, the better the result.
Change in Gait deviation index (GDI)
Time frame: 2 months post intervention
GDI provides a numerical value that expresses overall gait pathology (ranging from 0 to 100, where 100 indicates the absence of gait pathology). The higher the GDI, the better the result.
Change in Gait speed (metre/sec)
Time frame: 1 month post intervention
The faster the gait speed, the better the result.
Change in Gait speed (metre/sec)
Time frame: 2 months post intervention
The faster the gait speed, the better the result.
Change in Cadence (steps/ minute)
Time frame: 1 month post intervention
The higher the cadence, the better the result.
Change in Cadence (steps/ minute)
Time frame: 2 months post intervention
The higher the cadence, the better the result.
12 secondary outcomes
Change in Gross motor function measure (GMFM)
Time frame: 1 month post intervention
Change in Gross motor function measure (GMFM)
Time frame: 2 months post intervention
Change in Functional Assessment Questionnaire (FAQ)
Time frame: 1 month post intervention
Change in Functional Assessment Questionnaire (FAQ)
Time frame: 2 months post intervention
Change in EQ5D
Time frame: 1 month post intervention
Change in EQ5D
Time frame: 2months post intervention
Change in ICF-CY ratings
Time frame: 1 month post intervention
Change in ICF-CY ratings
Time frame: 2 months post intervention
Compliance
Time frame: 1 month post intervention
Compliance
Time frame: 2 months post intervention
Acceptance
Time frame: 1 month post intervention
Acceptance
Time frame: 2 months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Background: PubMed 26829077Mills PB, Dossa F. Transcutaneous Electrical Nerve Stimulation for Management of Limb Spasticity: A Systematic Review. Am J Phys Med Rehabil. 2016 Apr;95(4):309-18. doi: 10.1097/PHM.0000000000000437.
- Background: PubMed 22447997Wright PA, Durham S, Ewins DJ, Swain ID. Neuromuscular electrical stimulation for children with cerebral palsy: a review. Arch Dis Child. 2012 Apr;97(4):364-71. doi: 10.1136/archdischild-2011-300437.
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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.
Zhi Min Ng, MBBS principal investigator
KK Women's and Children's Hospital
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 suit in people with Cerebral Palsy and Spasticity, Muscle, run by KK Women's and Children's Hospital at 1 site in Singapore.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 Jan 2021. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhi Min Ng, MBBS (+65-6394 8975, ng.zhi.min@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gait Profile Score (GPS) (time frame: 1 month post intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04715334, which also lists 2 linked publications.
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 20 Jan 2021.