Clinical trial NCT04715334: Can Transcutaneous Electrical Stimulation Garment Improve Gait in Children With Cerebral Palsy?
Official title: Effectiveness in Improving Gait and Feasibility of a Transcutaneous Electrical Stimulation Garment in Children With Cerebral Palsy in Singapore
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Spasticity, Muscle
Keywords: gait
electrical stimulation
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Inerventions AB
First posted: 2021-01-20
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: pre and post intervention comparison
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Gait Profile Score (GPS)
timeFrame: 1 month post intervention
measure: Change in Gait Profile Score (GPS)
timeFrame: 2 months post intervention
measure: Change in Gait deviation index (GDI)
timeFrame: 1 month post intervention
measure: Change in Gait deviation index (GDI)
timeFrame: 2 months post intervention
measure: Change in Gait speed (metre/sec)
timeFrame: 1 month post intervention
measure: Change in Gait speed (metre/sec)
timeFrame: 2 months post intervention
measure: Change in Cadence (steps/ minute)
timeFrame: 1 month post intervention
measure: Change in Cadence (steps/ minute)
timeFrame: 2 months post intervention
Secondary outcomes:
measure: Change in Gross motor function measure (GMFM)
timeFrame: 1 month post intervention
measure: Change in Gross motor function measure (GMFM)
timeFrame: 2 months post intervention
measure: Change in Functional Assessment Questionnaire (FAQ)
timeFrame: 1 month post intervention
measure: Change in Functional Assessment Questionnaire (FAQ)
timeFrame: 2 months post intervention
measure: Change in EQ5D
timeFrame: 1 month post intervention
measure: Change in EQ5D
timeFrame: 2months post intervention
measure: Change in ICF-CY ratings
timeFrame: 1 month post intervention
measure: Change in ICF-CY ratings
timeFrame: 2 months post intervention
measure: Compliance
timeFrame: 1 month post intervention
measure: Compliance
timeFrame: 2 months post intervention
measure: Acceptance
timeFrame: 1 month post intervention
measure: Acceptance
timeFrame: 2 months post intervention
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KKWCH
Study officials:
affiliation: KK Women's and Children's Hospital
name: Zhi Min Ng, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.