NCT04653363

Brief Summary

Cerebral palsy (CP) is a non-progressive disturbance in the development of movement and posture that occurs in the prenatal or postnatal period, causing activity limitations. Most children and adolescents with CP experience limitations in their walking skills. Restrictions in the walking ability of children with CP are an important issue for both parents and healthcare professionals involved in their treatment. The evaluation of walking is of great importance in terms of determining the effectiveness of the physiotherapy program, shaping the program, planning orthopedic and surgical applications, and determining the effectiveness, especially in children with CP who have walking potential. In the literature, easy-to-use, valid and reliable observational gait analysis that can evaluate gait pathologies and clinical gait in children with CP are emphasized. These measurements are of great importance in clinical practice.The ability of backward walking gives the child a different task than normal, allowing the observation of body perception, trunk stability provided by anterior-posterior co-contractions, balance, correction and protective reactions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

November 26, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

December 15, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2021

Completed
Last Updated

November 23, 2021

Status Verified

April 1, 2021

Enrollment Period

11 months

First QC Date

November 26, 2020

Last Update Submit

November 21, 2021

Conditions

Keywords

Cerebral Palsybackward walkreliabilitygait

Outcome Measures

Primary Outcomes (1)

  • three meter backward walk test

    Three meters of distance will be measured and marked. When the signal is given, they will be asked to walk backwards safely and stop when they reach the marked point. Patients will be allowed to look back if they wish. The person conducting the test will walk with the patients for safety. The measurements will be repeated 3 times and the average of the times will be recorded.

    first evaulation of first day of assessment (observer1), second evaulation of first day of assessment (observer2), second evaulation of second day of assessment (observer1, second evaulation of second day of assessment (observer2)

Secondary Outcomes (5)

  • Timed Up and Go Test

    first day of assessment

  • Timed Up and Down Stairs Test

    first day of assessment

  • Four Square Step Test

    first day of assessment

  • Functional Reach Test

    first day of assessment

  • Pediatric Berg Balance Scale

    first day of assessment

Study Arms (3)

1

study1 is the patients who will be assessed by first rater.

Other: assessments

2

study2 is the patients who will be assessed by second rater.

Other: assessments

3

Theh are healty peers control patients who will be assessed by first rater.

Other: assessments

Interventions

All assesments will be done by the first physiotherapist. But only 3m backward test will be done by the first and second physiotherapist in the first day and second day.

Also known as: three meter backward test, Time Up and Go test, Timed Up and Down Stairs Test, Four Square Step Test, Functional Reach Test, Pediatric Berg Balance Scale, demografic information form, gross motor function classification system (GMFCS), modified ashworth scale, Communication Function Classification System
123

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

\- Children aged 8-18 years with a diagnosis of Hemiparetic and Diparetic SP with a Gross Motor Function Classification System (GMFCS) Level ≤ 3

You may qualify if:

  • Children aged 8-18 years with a diagnosis of Hemiparetic and Diparetic SP with a Gross Motor Function Classification System (GMFCS) Level ≤ 3
  • Children diagnosed with CP with Communication Function Classification System (CFCS) ≤ 3
  • Children with ≤ 3 according to the Modified Ashworth Scale (MASH)
  • Complete range of passive range of motion in the ankle and knee joints
  • Volunteering to participate in the study

You may not qualify if:

  • Not having Botulinum toxin or surgical operation in the last 6 months
  • Having contracture in the ankle and knee joints

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hatice Adıgüzel

Gaziantep, Batıkent, 27060, Turkey (Türkiye)

Location

Hatice Adıgüzel

Gaziantep, 27090, Turkey (Türkiye)

Location

Related Publications (1)

  • Celik OF, Adiguzel H, Kirmaci ZIK, Erel S, Demirguc A. Validity and reliability of the 3-meter backward walk test in children with cerebral palsy. Acta Neurol Belg. 2023 Aug;123(4):1439-1446. doi: 10.1007/s13760-023-02259-1. Epub 2023 Apr 4.

MeSH Terms

Conditions

Cerebral PalsyGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

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

Study Officials

  • hatice adıgüzel, PhD

    sanko Üniversitesi

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 26, 2020

First Posted

December 4, 2020

Study Start

December 15, 2020

Primary Completion

November 1, 2021

Study Completion

November 19, 2021

Last Updated

November 23, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations