NCT05088629

Brief Summary

The gait problems of the child with CP should be examined in detail. At this point, by assigning a different task to the child with the backward walking assessment, body perception, trunk stability provided by anterior-posterior cocontraction, balance, correction and protective reactions are observed. This observation ensures the exact determination of the problem that will guide the treatment. Back walking is a more difficult activity as it involves neuromuscular control and depends on proprioceptive sense and protective reflexes. In activities of daily living, backward walking is needed to perform tasks such as leaning on a chair and opening the door. The only test that can be applied to evaluate the ability to walk backwards is the 3 meter back walk test. This test was found to be valid and reliable both in the elderly population and in patients with total knee arthroplasty. In the literature, no study has been found on the factors affecting the three-meter backward walking skills in children with CP. The aim of this study is to examine the relationship between 3 meter back walk test and proprioception, trunk control and muscle strength.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

October 11, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

November 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

October 11, 2021

Last Update Submit

April 18, 2022

Conditions

Keywords

cerebral palsyback walkproprioceptiontrunk control

Outcome Measures

Primary Outcomes (1)

  • 3 meter back walk test

    A distance of three meters 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.

    At baseline

Secondary Outcomes (4)

  • Proprioception

    At baseline

  • Trunk Control Measurement Scale

    At baseline

  • Muscle Strength

    At baseline

  • Gillette Functional Walking Assessment Questionnaire

    At baseline

Study Arms (1)

One group

OTHER

3-meter Walk Back Test, Proprioception, Trunk Control and Muscle Strength test

Diagnostic Test: Clinical Tests

Interventions

Clinical TestsDIAGNOSTIC_TEST

Clinical Tests

One group

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • The age of onset of maturation of walking, in terms of covering the maturation ages and between 6-15 years old,
  • Children with CP with a Communication Function Classification System (CFCS) ≤ 3,
  • Children with upper extremity muscles ≤ 2 according to the Modified Ashworth Scale (MASH)
  • Children in Level-I-II, which are groups with independent walking ability according to Gross Motor Function Classification System,
  • Not having any known vision problems in terms of not affecting the postural control responses,
  • Not using any pharmacological agent that may affect muscle tone,
  • Able to follow verbal commands without mental retardation at a level that interferes with communication,
  • Those who have not had any Boutilinum Toxin injection and/or orthopedic surgery in the lower extremity in the last six months,
  • Children without epileptic seizures will be included.

You may not qualify if:

  • Having contractures in any joint of the hip, knee and ankle in the lower extremity,
  • Children with hearing and vision problems with any diagnosis will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zekiye İpek Katırcı Kırmacı

Gaziantep, Turkey (Türkiye)

Location

Related Publications (1)

  • Katirci E, Adiguzel H, Katirci Kirmaci ZI, Ergun N. The relationship between the backward walking and proprioception, trunk control, and muscle strength in children with cerebral palsy. Ir J Med Sci. 2023 Oct;192(5):2391-2399. doi: 10.1007/s11845-022-03270-w. Epub 2023 Jan 6.

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Nevin ERGUN, Prof.

    Sanko University

    STUDY DIRECTOR
  • Enver KATIRCI, pt

    Rehabilitation Center

    PRINCIPAL INVESTIGATOR
  • Hatice ADIGÜZEL, asst. prof.

    Kahramanmaras Sutcu Imam University

    STUDY DIRECTOR
  • Zekiye İpek KATIRCI KIRMACI, asst. prof.

    Kahramanmaras Sutcu Imam University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

October 11, 2021

First Posted

October 22, 2021

Study Start

November 15, 2021

Primary Completion

January 15, 2022

Study Completion

February 15, 2022

Last Updated

April 19, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations