Clinical trial NCT03662139: Dynamic Gait Index in Hemiplegic Cerebral Palsy
Official title: Reliability and Validity of the Dynamic Gait Index in Children With Hemiplegic Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Hemiplegic Cerebral Palsy
Gait Disorders, Neurologic
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 16 spastic unilateral cerebral palsy patients, between 6 - 14 years of age, and 16 healthy volunteer peers

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Dynamic Gait Index (DGI)
timeFrame: Day 1 (Baseline) in both groups (Cerebral Palsy group same day by two different evaluators), Day 7-10 in the Cerebral Palsy group only
Secondary outcomes:
measure: Pediatric Balance Scale (PBS)
timeFrame: Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)
measure: Timed Up and Go Test (TUG)
timeFrame: Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)
measure: Four Square Step Test (FSST)
timeFrame: Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine, Pendik Research and Education Hospital, Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Department of PM&R, Marmara University School of Medicine
name: Naime Evrim Karadag Saygi, Prof
role: STUDY_CHAIR
affiliation: Department of PM&R, Marmara University School of Medicine
name: Ayca Evkaya, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.