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

NCT04715334 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-01-20

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy
  • Spasticity, Muscle

Interventions

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.

Sponsors & Collaborators

  • Inerventions AB

    collaborator UNKNOWN

  • KK Women's and Children's Hospital

    lead OTHER_GOV

Principal Investigators

  • Zhi Min Ng, MBBS · KK Women's and Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-08
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04715334 on ClinicalTrials.gov