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Completed

NCT Number: NCT03662139

Dynamic Gait Index in Hemiplegic Cerebral Palsy

The purpose of this study is to assess validity and reliability of Dynamic Gait Index (DGI) in patients with unilateral spastic cerebral palsy

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Gait Disorders, Neurologic Hemiplegic Cerebral Palsy Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Istanbul, 34899, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dynamic Gait Index

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Reliability and Validity of the Dynamic Gait Index in Children With Hemiplegic Cerebral Palsy

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 7, 2018
Registry last updated
Jan 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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