- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03662139
Dynamic Gait Index in Hemiplegic Cerebral Palsy
Reliability and Validity of the Dynamic Gait Index in Children With Hemiplegic Cerebral Palsy
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34899
- Marmara University School of Medicine, Pendik Research and Education Hospital, Department of Physical Medicine and Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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
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Dynamic Gait Index is a clinical tool for assessing functional balance and gait variability in people with neurologic conditions
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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
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Dynamic Gait Index is a clinical tool for assessing functional balance and gait variability in people with neurologic conditions
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Dynamic Gait Index (DGI)
Time Frame: Day 1 (Baseline) in both groups (Cerebral Palsy group same day by two different evaluators), Day 7-10 in the Cerebral Palsy group only
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Dynamic Gait Index is a tool consisting eight items; gait on a flat surface, changing speed, gait with horizontal and vertical head turns, pivot turn, stepping over obstacle, Minimum score is 0, maximum score is 24, higher scores indicate better outcome.
Scores lower than 19 indicate risk of falling and above 22 define safe ambulance.
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Day 1 (Baseline) in both groups (Cerebral Palsy group same day by two different evaluators), Day 7-10 in the Cerebral Palsy group only
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pediatric Balance Scale (PBS)
Time Frame: Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)
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Pediatric Balance Scale is a functional balance scale adapted and customized from Berg Balance Scale for use with children.
Pediatric Balance Scale is a 14-item, criterion-referenced measure, which examines functional balance in the context of everyday tasks.
It can easily be administered and scored in less than 20 minutes using equipment commonly found in schools and clinics.
Scoring (0-4) is based on how long a specific movement or position is performed, how long the position can be maintained, or how much assistance it requires.
Minimum score is 0, maximum score is 56; higher scores indicate better dynamic balance.
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Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)
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Timed Up and Go Test (TUG)
Time Frame: Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)
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TUG is a test determining fall risk and balance by their physical performance in sitting to standing, and walking.
Test begins with the patient sitting back in a standart chair and when asked walking 10 feets on a certain line than back to the chair sitting.
Completion time is recorded for the task and longer time indicates worse ambulation and higher risk of fall.
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Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)
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Four Square Step Test (FSST)
Time Frame: Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)
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FSST, assesses dynamic balance and coordination through stepping forwards, sideways, and backwards in a timed fashion.
It is a valid and reliable tool in children with cerebral palsy.
The test requires the participant to step forwards, backwards and sideways over four-square shaped line in a specified sequence.
Completion time is recorded for the task and longer time indicates worse ambulation and higher risk of fall.
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Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Naime Evrim Karadag Saygi, Prof, Department of PM&R, Marmara University School of Medicine
- Principal Investigator: Ayca Evkaya, PT, Department of PM&R, Marmara University School of Medicine
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Dev Med Child Neurol. 2007 Jun;49(6):480.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02.04.2018-113
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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