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Trial record 88 of 163 for:    Recruiting, Not yet recruiting, Available Studies | "Cerebral Palsy"

Dynamic Gait Index in Hemiplegic Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT03662139
Recruitment Status : Not yet recruiting
First Posted : September 7, 2018
Last Update Posted : December 11, 2018
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.


Study Type : Observational
Estimated 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
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : June 15, 2019
Estimated Study Completion Date : September 15, 2019

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: 15 minutes ]
    DGI 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, gait in narrow base of support and steps. Each item is graded on a 4-point scale ranging from 0 (severe disability) to 3 (normal walking ability without a walking assistant). Total score is between 0 to 24, higher scores indicating better ambulation. Scores lower than 19 indicate risk of falling and above 22 define safe ambulance.


Secondary Outcome Measures :
  1. Pediatric Balance Scale (PBS) [ Time Frame: 15 minutes ]
    PBS is a functional balance scale adapted and customized from Berg Balance Scale for use with children. The PBS 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. The highest score in PBS is 56, indicating better balance and lowest score is 0.

  2. Timed Up and Go Test (TUG) [ Time Frame: 5 minutes ]
    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: 5 minutes ]
    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 a patinet 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.

  4. Modified Ashworth Scale (MAS) [ Time Frame: 5 minutes ]
    Modified Ashworth Scale for grading spasticity is a six-point scale. Measuring muscle spasticity includes manually moving a limb through its ROM to passively stretch and evaluate degree of spasticity of specific muscle groups. Scoring is as follows: (0) No increase in muscle tone, (1) Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension, (1+) Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM, (2) More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, (3) Considerable increase in muscle tone, passive movement difficult, (4) Affected part(s) rigid in flexion or extension



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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


Contacts
Contact: Duygu G Karali Bingul, MD 00902166570606 ext 1628 d_karali@yahoo.com
Contact: Naime Evrim Karadag Saygi, Prof 00902166570606 ext 1628 evrimkaradag4@hotmail.com

Sponsors and Collaborators
Marmara University
Investigators
Study Chair: Naime Evrim Karadag Saygi, Prof Marmara University School of Medicine, Pendik Research and Education Hospital, Department of Physical Medicine and Rehabilitation, Istanbul / Turkey 34899

Publications:
Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT03662139     History of Changes
Other Study ID Numbers: 02.04.2018-113
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Gait Disorders, Neurologic
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases