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Dynamic Gait Index in Hemiplegic Cerebral Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662139
Recruitment Status : Completed
First Posted : September 7, 2018
Results First Posted : November 5, 2019
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Marmara University

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

Condition or disease Intervention/treatment
Cerebral Palsy Hemiplegic Cerebral Palsy Gait Disorders, Neurologic Other: Dynamic Gait Index

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.

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Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Reliability and Validity of the Dynamic Gait Index in Children With Hemiplegic Cerebral Palsy
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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
Other: Dynamic Gait Index
Dynamic Gait Index is a clinical tool for assessing functional balance and gait variability in people with neurologic conditions




Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. 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) ]
    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.

  2. 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) ]
    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.

  3. 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) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
16 spastic unilateral cerebral palsy patients, between 6 - 14 years of age, and 16 healthy volunteer peers
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662139


Locations
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Turkey
Marmara University School of Medicine, Pendik Research and Education Hospital, Department of Physical Medicine and Rehabilitation
Istanbul, Turkey, 34899
Sponsors and Collaborators
Marmara University
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Marmara University:
Study Protocol  [PDF] April 2, 2018
Statistical Analysis Plan  [PDF] April 2, 2018

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT03662139    
Other Study ID Numbers: 02.04.2018-113
First Posted: September 7, 2018    Key Record Dates
Results First Posted: November 5, 2019
Last Update Posted: January 29, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Gait Disorders, Neurologic
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases