Can Transcutaneous Electrical Stimulation Garment Improve Gait in Children With Cerebral Palsy?

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness in Improving Gait and Feasibility of a Transcutaneous Electrical Stimulation Garment in Children With Cerebral Palsy in Singapore

Conditions
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Cerebral Palsy, Spasticity, Muscle

Intervention / Treatment
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* Device: Mollii suit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: pre and post intervention comparison
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm study<br>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. | Device: Mollii suit<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 2 months post intervention | 
| Change in Gait speed (metre/sec) | The faster the gait speed, the better the result. | 1 month post intervention | 
| Change in Gait speed (metre/sec) | The faster the gait speed, the better the result. | 2 months post intervention | 
| Change in Cadence (steps/ minute) | The higher the cadence, the better the result. | 1 month post intervention | 
| Change in Cadence (steps/ minute) | The higher the cadence, the better the result. | 2 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 2 months post intervention | 
| Compliance | Compliance is measured using log of use of mollii suit. | 1 month post intervention | 
| Compliance | Compliance is measured using log of use of mollii suit. | 2 months post intervention | 
| Acceptance | Acceptance to the mollii suit is evaluated qualitatively using an open-ended questionnaire filled up by patient and caregivers | 1 month post intervention | 
| Acceptance | Acceptance to the mollii suit is evaluated qualitatively using an open-ended questionnaire filled up by patient and caregivers | 2 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gait, electrical stimulation