Dynamic Gait Index in Hemiplegic Cerebral Palsy

NCT03662139 | Completed Results

• 1 other identifier: 02.04.2018-113
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Cerebral Palsy; Hemiplegic Cerebral Palsy; Gait Disorders, Neurologic

Outcome Measures

Primary Outcomes (1)

• Dynamic Gait Index (DGI)

  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.

  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 (3)

• Pediatric Balance Scale (PBS)

  Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)

• Timed Up and Go Test (TUG)

  Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)

• Four Square Step Test (FSST)

  Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)

Study Arms (2)

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

Other: Dynamic Gait Index

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

Other: Dynamic Gait Index

Interventions

Dynamic Gait Index OTHER

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

Cerebral Palsy Group; Healthy Control Group

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

16 spastic unilateral cerebral palsy patients, between 6 - 14 years of age, and 16 healthy volunteer peers

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

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

Istanbul, 34899, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 17057441 BACKGROUND

• 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.

  PMID: 23813090 BACKGROUND

• 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.

  PMID: 26318393 BACKGROUND

• 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.

  PMID: 27661230 BACKGROUND

• 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.

  PMID: 17370477 BACKGROUND

• 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.

  PMID: 31590067 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Naime Evrim Karadag-Saygi, Prof. Dr.
• Organization: Department of PM&R, Marmara University School of Medicine

evrimkaradag4@hotmail.com

00902166570606

Study Officials

• Naime Evrim Karadag Saygi, Prof

  Department of PM&R, Marmara University School of Medicine

  STUDY CHAIR

• Ayca Evkaya, PT

  Department of PM&R, Marmara University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 7, 2018
• Study Start: April 1, 2018
• Primary Completion: June 30, 2018
• Study Completion: December 1, 2018
• Last Updated: January 29, 2020
• Results First Posted: November 5, 2019

Record last verified: 2019-11

Locations

TU (1)