NCT04686630

Brief Summary

Children with Cerebral Palsy have generally limited selective motor control which affects their ability to complete functional tasks Selective Motor Control has been shown to correlate with specific characteristics of gait, however in video based observational gait analysis, the sub phases of the gait cycle, which are affected by selective motor control, has not been investigated in children with Cerebral Palsy. Therefore the aim of this study was determine the relationship between Edinburgh Visual Gait Score and Selective Motor Control of the Lower Extremity test in children with cerebral palsy. Forty-two cerebral palsy children with Gross Motor Function Classification System level I-II-III and between 4-18 ages were participated for the study. After the demographic characteristics and all assessments of the patients were recorded, the gait characteristics of children were assessed by video based observational gait analysis. According to Edinburgh Visual Gait Score, phases of gait were analyzed. Keywords: Cerebral Palsy, Selective Motor Control, Gait, Edinburgh Visual Gait Score

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 17, 2020

Completed
10 months until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
Last Updated

December 29, 2020

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

March 17, 2020

Last Update Submit

December 22, 2020

Conditions

Keywords

Cerebral Palsy, Selective Motor Control, SCALE Test, Edinburgh Gait Score

Outcome Measures

Primary Outcomes (1)

  • Impaired lower-extremity Selective Voluntary Motor Control are noticeably related with the foot and ankle movements in swing and initial stance during walking as well as the total Edinburgh Visual Gait Score and sagittal and frontal trunk movements.

    Edinburgh visual gait score is a tool for assessment of the gait phases. Selective Voluntary Motor Control was assessed with the SCALE Test. The SCALE Test consists of 5 items, and each item can be scored between 0 and 2 (0 = unable, 1 = impaired, 2 =normal). For each limb, high scores (maximum score of 10) indicate the best SVMC. Addition,assess of Edinburgh Visual Gait Score (EVGS) (0=normal, 1=moderate or mild pathology, 2=severe pathology). So 0 here means the best score at EVGS.

    about 1 year

Study Arms (1)

Single group

Only observational study

Other: Video based observational gait analysis and SCALE Test

Interventions

Twenty-four spastic diparesis and eighteen spastic hemiparesis cases were included in the study. Data was collected from 84 lower extremities. There were 22 female and 20 male patients aged between 4-18 years. Personal and disease-related information of 42 individuals with diplegic or hemiparetic CP were recorded by using the data collection form. Information collection form; The patient's name-surname, age, gender, height, weight, history, gestational age, birth weight, SCALE Test, GMFCS, Modified Ashworth Scale (MAS), Range of Motion (ROM), EVGS, affected side and previous surgical histories were recorded and their functional levels were determined and recorded.

Single group

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children with a diagnosis of diplegic or hemiparetic CP. Between 4-18 years old, GMFCS level I-II-III, Can understand simple verbal commands,

You may qualify if:

  • Children with a diagnosis of diplegic or hemiparetic CP.
  • Between 4-18 years old,
  • GMFCS level I-II-III,
  • Can understand simple verbal commands,

You may not qualify if:

  • Children with ataxic and dyskinetic type CP were identified.
  • Children who exhibit discordant attitudes during the assessment (crying, indignation),
  • Families and children who want to quit working anywhere in the study,
  • Children who could not complete the assessment were identified as.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeditepe University

Istanbul, Ataşehir, 34755, Turkey (Türkiye)

Location

Related Publications (1)

  • Sardogan C, Muammer R, Akalan NE, Sert R, Bilgili F. Determining the relationship between the impairment of selective voluntary motor control and gait deviations in children with cerebral palsy using simple video-based analyses. Gait Posture. 2021 Oct;90:295-300. doi: 10.1016/j.gaitpost.2021.08.019. Epub 2021 Aug 26.

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Rasmi Muammer, Prof. Dr.

    Yeditepe University

    PRINCIPAL INVESTIGATOR
  • Nazif Ekin Akalan, Prof. Dr.

    Istanbul Kültür University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Candidate of MSc Physiotherapist

Study Record Dates

First Submitted

March 17, 2020

First Posted

December 29, 2020

Study Start

August 1, 2019

Primary Completion

December 30, 2019

Study Completion

February 15, 2020

Last Updated

December 29, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will share

This study will be published in a scientific journal.

Shared Documents
ICF

Locations