Dynamic Gait Index in Hemiplegic Cerebral Palsy

NCT ID: NCT03662139

Last Updated: 2020-01-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2018-12-01

Brief Summary

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The purpose of this study is to assess validity and reliability of Dynamic Gait Index (DGI) in patients with unilateral spastic cerebral palsy

Detailed Description

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Cerebral Palsy (CP) is a childhood onset, lifelong neurological disorder, attributed to non-progressive injury of the fetal or immature brain. It causes movement deterioration and activity limitation. In CP patients increase in slow walking speed, shorter step length, and longer duration in the double support phase are common. Such gait changes are thought to reflect the unbalanced walking pattern seen in these children. Although children with CP are well known to have poor balance and high fall incidence, little effort has been made to quantify the dynamic walking stability of these children.

The Dynamic Gait Index (DGI) is a performance-based tool developed by Shumway-Cook and Woollacott to quantitatively measure dynamic balance capabilities. It also evaluates the individual's ability to modify gait in response to changing gait task requirements. Despite it's widespread use in the elderly population, DGI has not yet been investigated in children with neurological conditions. Considering that it takes a little time to apply the test, it may be advantageous for children in terms of simplicity and ease of administration.

In this study the investigators aim to validate and assess interrater and test - retest reliabilities of Turkish version of Dynamic Gait Index in children with unilateral, spastic cerebral palsy.

Conditions

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Cerebral Palsy Hemiplegic Cerebral Palsy Gait Disorders, Neurologic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cerebral Palsy Group

16 patients will be included. Dynamic Gait Index and other assessments will be performed twice with a 7 - 10 day interval by two evaluators

Dynamic Gait Index

Intervention Type OTHER

Dynamic Gait Index is a clinical tool for assessing functional balance and gait variability in people with neurologic conditions

Healthy Control Group

16 healthy children will be included. Dynamic Gait Index and other assessments will be performed twice with a 7 - 10 day interval by two evaluators

Dynamic Gait Index

Intervention Type OTHER

Dynamic Gait Index is a clinical tool for assessing functional balance and gait variability in people with neurologic conditions

Interventions

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Dynamic Gait Index

Dynamic Gait Index is a clinical tool for assessing functional balance and gait variability in people with neurologic conditions

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of spastic unilateral cerebral palsy
* Age between 4 - 16
* Able to stand and walk without any orthosis or special equipment
* Volunteer to study

Exclusion Criteria

* Being unable to walk
* Having cognitive disorder
* History of orthopedic surgery or any intervention for spasticity within the previous 12 months
* Uncontrolled epilepsy
* Visual conditions that prevent full participation to assessments
* Lower extremity contracture that may affect assessments
Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Naime Evrim Karadag Saygi, Prof

Role: STUDY_CHAIR

Department of PM&R, Marmara University School of Medicine

Ayca Evkaya, PT

Role: PRINCIPAL_INVESTIGATOR

Department of PM&R, Marmara University School of Medicine

Locations

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Marmara University School of Medicine, Pendik Research and Education Hospital, Department of Physical Medicine and Rehabilitation

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Franjoine MR, Gunther JS, Taylor MJ. Pediatric balance scale: a modified version of the berg balance scale for the school-age child with mild to moderate motor impairment. Pediatr Phys Ther. 2003 Summer;15(2):114-28. doi: 10.1097/01.PEP.0000068117.48023.18.

Reference Type BACKGROUND
PMID: 17057441 (View on PubMed)

Shumway-Cook A, Taylor CS, Matsuda PN, Studer MT, Whetten BK. Expanding the scoring system for the Dynamic Gait Index. Phys Ther. 2013 Nov;93(11):1493-506. doi: 10.2522/ptj.20130035. Epub 2013 Jun 27.

Reference Type BACKGROUND
PMID: 23813090 (View on PubMed)

Bandong AN, Madriaga GO, Gorgon EJ. Reliability and validity of the Four Square Step Test in children with cerebral palsy and Down syndrome. Res Dev Disabil. 2015 Dec;47:39-47. doi: 10.1016/j.ridd.2015.08.012. Epub 2015 Aug 27.

Reference Type BACKGROUND
PMID: 26318393 (View on PubMed)

Carey H, Martin K, Combs-Miller S, Heathcock JC. Reliability and Responsiveness of the Timed Up and Go Test in Children With Cerebral Palsy. Pediatr Phys Ther. 2016 winter;28(4):401-8. doi: 10.1097/PEP.0000000000000301.

Reference Type BACKGROUND
PMID: 27661230 (View on PubMed)

Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.

Reference Type BACKGROUND
PMID: 17370477 (View on PubMed)

Evkaya A, Karadag-Saygi E, Karali Bingul D, Giray E. Validity and reliability of the Dynamic Gait Index in children with hemiplegic cerebral palsy. Gait Posture. 2020 Jan;75:28-33. doi: 10.1016/j.gaitpost.2019.09.024. Epub 2019 Sep 23.

Reference Type DERIVED
PMID: 31590067 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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02.04.2018-113

Identifier Type: -

Identifier Source: org_study_id

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