Does Increasing Auditory Cueing Affect Gait Parameters in Children With Cerebral Palsy During a Functional Task?

August 4, 2016 updated by: Institute of Child Health
To determine the clinical efficacy of auditory cueing using a cross over design to investigate whether increasing auditory cueing frequency by 20% above self paced cadence affects gait parameters in children with Cerebral Palsy when performing a functional task.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction: Cerebral Palsy is a non progressive disorder occurring in early brain development, resulting in inefficient ambulatory pattern. The use of sensory cues to facilitate loco-motor activity has been suggested as providing the necessary trigger to synchronise movement with greater beneficial outcomes observed at higher frequency intensities within the adult population. Thus auditory cueing could have the potential to alter gait parameters during a functional task.

Aim: To explore if increasing auditory cueing frequency (AC20) affects gait during a functional task compared to auditory cueing at self-paced cadence (ACSC).

Method: Nineteen children with CP levels 1 and 2 on the Gross Motor Function Classification Scale participated using paired analysis. Outcomes were compared to the mean values for temporal spatial gait data within the conditions using a cross over design. TS data was obtained by using the GAITRite® walkway system whilst walking holding a cup.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children with Cerebral Palsy aged 5 to 11 years old who were scored as levels 1 to 2 on the Gross Motor Function Classification Scale.
  • Cognitive status average or above on the Weschler Intelligence Scale for children.
  • Able to hear without the use of a hearing aid.

Exclusion Criteria:

  • Hearing impairment that results in the use of a hearing aid.
  • Walking with assistance of a mobility aid.
  • Cardiovascular problems or other associated health problems which limits the child waking multiple times over the GAITRite®.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Auditory cueing at self paced cadence
Participants performed a functional task with auditory cueing set at self paced cadence.
Device: Auditory Cueing
Auditory cueing set at different frequency rates
Experimental: Cueing at 20% above self paced cadence
Participants performed a functional task with auditory cueing set at 20% above self paced cadence whilst performing a functional task.
Device: Auditory Cueing
Auditory cueing set at different frequency rates

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Step Length as Measured by the Gaitrite Walk-way System.
Time Frame: Data was collected at a single time point for each condition. Conditions occurred within a two week time period.
The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of length was recorded in centimetres.
Data was collected at a single time point for each condition. Conditions occurred within a two week time period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Velocity as Measured by the Gaitrite Walk-way System.
Time Frame: Data was collected at a single time point for each condition. Conditions occurred within a two week time period.
The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of velocity was recorded in cm's per second.
Data was collected at a single time point for each condition. Conditions occurred within a two week time period.
Step Time as Measured by the Gaitrite Walk-way System.
Time Frame: Data was collected at a single time point for each condition. Conditions occurred within a two week time period.
The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of step time was recorded in seconds.
Data was collected at a single time point for each condition. Conditions occurred within a two week time period.
Cadence as Measured by the Gaitrite Walk-way System.
Time Frame: Data was collected at a single time point for each condition. Conditions occurred within a two week time period.
The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of cadence was recorded in steps per minute.
Data was collected at a single time point for each condition. Conditions occurred within a two week time period.
Time Spent in Double Support as Measured by the Gaitrite Walk-way System.
Time Frame: Data was collected at a single time point for each condition. Conditions occurred within a two week time period.
The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. This was record in percentage of time spent in double support (%).
Data was collected at a single time point for each condition. Conditions occurred within a two week time period.
Time Spent in Single Support as Measured by the Gaitrite Walk-way System.
Time Frame: Data was collected at a single time point for each condition. Conditions occurred within a two week time period.
The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. This was record in percentage of time spent in double support (%).
Data was collected at a single time point for each condition. Conditions occurred within a two week time period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Child Health

Collaborators

Gateshead Health NHS Foundation Trust

Investigators

  • Principal Investigator: Melissa Walk-ley, University College, London
  • Study Chair: Ann Lyons, PHD, Northumberia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

January 7, 2016

First Submitted That Met QC Criteria

January 25, 2016

First Posted (Estimate)

January 28, 2016

Study Record Updates

Last Update Posted (Estimate)

August 31, 2016

Last Update Submitted That Met QC Criteria

August 4, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 141A22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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