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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy; Spasticity, Muscle
• Intervention / Treatment: Device: Mollii suit

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhi Min Ng, MBBS; Phone Number: +65-6394 8975; Email: ng.zhi.min@singhealth.com.sg

Study Locations

• Singapore
  • Singapore, Singapore, 229899
    • Recruiting
    • KKWCH
    • Contact: Zhi Min Ng, MBBS; Email: ng.zhi.min@singhealth.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single arm study; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital
• Collaborators: Inerventions AB
• Investigators: Principal Investigator: Zhi Min Ng, MBBS, KK Women's and Children's Hospital

Publications and helpful links

General 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.
• Wright 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 14, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: gait; electrical stimulation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Cerebral Palsy; Muscle Spasticity
• Other Study ID Numbers: 2020/2150

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No