NCT04850690

Brief Summary

Various gait deviations are observed in children with cerebral palsy. Our aim was to determine the effect of cognitive task (CT) and motor task (MT) on gait in children with cerebral palsy (CP). 15 children with CP, between 9-15 years old, with Communication Function Classification System (CFSS) level I, with Gross Motor Function Classification System (GMFCS) and Manual Ability Classification System (MACS) level I-II were included in the study. The gait with four different conditions (single gait, CT, MT and CT\&MT) was evaluated by Kinovea video analysis method on a 10-meter course. Results:

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2018

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

November 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2021

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

April 14, 2021

Last Update Submit

April 15, 2021

Conditions

Keywords

Cerebral PalsyCognitive TaskDual Task ParadigmMotor TaskGait

Outcome Measures

Primary Outcomes (1)

  • 2D Gait analysis

    Kinovea video analysis

    through study completion, an average of 1 year

Study Arms (1)

Children with hemiparetic Cerebral palsy

15 children with CP, between 9-15 years old

Diagnostic Test: 2D Gait analysis

Interventions

2D Gait analysisDIAGNOSTIC_TEST

The gait with four different conditions (single gait, Cognitive Task, Motor Task and Cognitive Task\&Motor Task) was evaluated by Kinovea video analysis method on a 10-meter course. * Single: Walking without task at a self-selected speed * Cognitive Task (CT): Walking while counting down rhythmically from 20 in threes * Motor Task (MT): Walking while carrying an empty box * CT + MT: Walking while carrying an empty box and counting down rhythmically from 20 in threes

Children with hemiparetic Cerebral palsy

Eligibility Criteria

Age9 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

15 children with Cerebral Palsy, between 9-15 years old

You may qualify if:

  • having been diagnosed with CP in the health committee
  • being between 9-15 years of age, having a mental level as "normal" (in terms of compliance with the exercises)
  • being in Gross Motor Function Classification System (GMFSC) Level I-II
  • being in Manual Ability Classification System (MACS) Level I-II
  • being in Communication Function Classification System (CFSS) Level I (communication method is speech).

You may not qualify if:

  • having a mental retardation
  • having severe vision impairment
  • underwenting Botulinum Toxin (BOTOX) injection or surgery affecting lower extremities in the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34815, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral PalsyGait Disorders, NeurologicOrientation, SpatialMotor Activity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpatial BehaviorBehavior

Study Officials

  • Miray BUDAK, PhD

    Medipol University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Miray Budak

Study Record Dates

First Submitted

April 14, 2021

First Posted

April 20, 2021

Study Start

November 1, 2018

Primary Completion

May 1, 2019

Study Completion

July 1, 2019

Last Updated

April 20, 2021

Record last verified: 2021-04

Locations