NCT04715334

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

December 8, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

December 7, 2020

Last Update Submit

January 14, 2021

Conditions

Cerebral PalsySpasticity, Muscle

Keywords

gaitelectrical stimulation

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (12)

  • Change in Gross motor function measure (GMFM)

    1 month post intervention

  • Change in Gross motor function measure (GMFM)

    2 months post intervention

  • Change in Functional Assessment Questionnaire (FAQ)

    1 month post intervention

  • Change in Functional Assessment Questionnaire (FAQ)

    2 months post intervention

  • Change in EQ5D

    1 month post intervention

  • +7 more secondary outcomes

Study Arms (1)

Single arm study

EXPERIMENTAL

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

Interventions

Mollii suitDEVICE

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.

Single arm study

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KKWCH

Singapore, 229899, Singapore

RECRUITING

Related Publications (2)

  • 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.

    PMID: 26829077BACKGROUND

  • 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.

    PMID: 22447997BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyMuscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Zhi Min Ng, MBBS

    KK Women's and Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi Min Ng, MBBS

CONTACT

+65-6394 8975ng.zhi.min@singhealth.com.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: pre and post intervention comparison
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant

Study Record Dates

First Submitted

December 7, 2020

First Posted

January 20, 2021

Study Start

December 8, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations

SG(1)