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

Primary Purpose

Cerebral Palsy, Children

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Auditory Cueing
Sponsored by
Institute of Child Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Auditory Cueing, Gait

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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®.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Auditory cueing at self paced cadence

    Cueing at 20% above self paced cadence

    Arm Description

    Participants performed a functional task with auditory cueing set at self paced cadence.

    Participants performed a functional task with auditory cueing set at 20% above self paced cadence whilst performing a functional task.

    Outcomes

    Primary Outcome Measures

    Step Length as Measured by the Gaitrite Walk-way System.
    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.

    Secondary Outcome Measures

    Velocity as Measured by the Gaitrite Walk-way System.
    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.
    Step Time as Measured by the Gaitrite Walk-way System.
    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.
    Cadence as Measured by the Gaitrite Walk-way System.
    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.
    Time Spent in Double Support as Measured by the Gaitrite Walk-way System.
    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 (%).
    Time Spent in Single Support as Measured by the Gaitrite Walk-way System.
    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 (%).

    Full Information

    First Posted
    January 7, 2016
    Last Updated
    August 4, 2016
    Sponsor
    Institute of Child Health
    Collaborators
    Gateshead Health NHS Foundation Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02666560
    Brief Title
    Does Increasing Auditory Cueing Affect Gait Parameters in Children With Cerebral Palsy During a Functional Task?
    Official Title
    Does Increasing Auditory Cueing Affect Gait Parameters in Children With Cerebral Palsy During a Functional Task?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institute of Child Health
    Collaborators
    Gateshead Health NHS Foundation Trust

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy, Children
    Keywords
    Auditory Cueing, Gait

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    19 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Auditory cueing at self paced cadence
    Arm Type
    Active Comparator
    Arm Description
    Participants performed a functional task with auditory cueing set at self paced cadence.
    Arm Title
    Cueing at 20% above self paced cadence
    Arm Type
    Experimental
    Arm Description
    Participants performed a functional task with auditory cueing set at 20% above self paced cadence whilst performing a functional task.
    Intervention Type
    Device
    Intervention Name(s)
    Auditory Cueing
    Intervention Description
    Auditory cueing set at different frequency rates
    Primary Outcome Measure Information:
    Title
    Step Length as Measured by the Gaitrite Walk-way System.
    Description
    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.
    Time Frame
    Data was collected at a single time point for each condition. Conditions occurred within a two week time period.
    Secondary Outcome Measure Information:
    Title
    Velocity as Measured by the Gaitrite Walk-way System.
    Description
    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.
    Time Frame
    Data was collected at a single time point for each condition. Conditions occurred within a two week time period.
    Title
    Step Time as Measured by the Gaitrite Walk-way System.
    Description
    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.
    Time Frame
    Data was collected at a single time point for each condition. Conditions occurred within a two week time period.
    Title
    Cadence as Measured by the Gaitrite Walk-way System.
    Description
    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.
    Time Frame
    Data was collected at a single time point for each condition. Conditions occurred within a two week time period.
    Title
    Time Spent in Double Support as Measured by the Gaitrite Walk-way System.
    Description
    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 (%).
    Time Frame
    Data was collected at a single time point for each condition. Conditions occurred within a two week time period.
    Title
    Time Spent in Single Support as Measured by the Gaitrite Walk-way System.
    Description
    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 (%).
    Time Frame
    Data was collected at a single time point for each condition. Conditions occurred within a two week time period.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    11 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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®.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Melissa Walk-ley
    Organizational Affiliation
    University College, London
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ann Lyons, PHD
    Organizational Affiliation
    Northumberia University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    12234229
    Citation
    Rosenbaum PL, Walter SD, Hanna SE, Palisano RJ, Russell DJ, Raina P, Wood E, Bartlett DJ, Galuppi BE. Prognosis for gross motor function in cerebral palsy: creation of motor development curves. JAMA. 2002 Sep 18;288(11):1357-63. doi: 10.1001/jama.288.11.1357.
    Results Reference
    background
    Citation
    Kwak, E. (2007) Effect of rhythmic auditory stimulation on controlling stepping cadence of individuals with mental retardation and cerebral palsy. International journal of special education, vol 27, no 3, pp. 1-8.
    Results Reference
    background
    PubMed Identifier
    22142756
    Citation
    Kim SJ, Kwak EE, Park ES, Lee DS, Kim KJ, Song JE, Cho SR. Changes in gait patterns with rhythmic auditory stimulation in adults with cerebral palsy. NeuroRehabilitation. 2011;29(3):233-41. doi: 10.3233/NRE-2011-0698.
    Results Reference
    background

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

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