Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:41 PM
Study NCT ID:
NCT04715334
Status:
UNKNOWN
Last Update Posted:
2021-01-20
First Post:
2020-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can Transcutaneous Electrical Stimulation Garment Improve Gait in Children With Cerebral Palsy?
Sponsor:
KK Women's and Children's Hospital
Organization:
Study Overview
Official Title:
Effectiveness in Improving Gait and Feasibility of a Transcutaneous Electrical Stimulation Garment in Children With Cerebral Palsy in Singapore
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: