NCT02666560

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
7 months until next milestone

Results Posted

Study results publicly available

August 31, 2016

Completed
Last Updated

August 31, 2016

Status Verified

April 1, 2016

Enrollment Period

1 month

First QC Date

January 7, 2016

Results QC Date

April 18, 2016

Last Update Submit

August 4, 2016

Conditions

Keywords

Auditory CueingGait

Outcome Measures

Primary Outcomes (1)

  • 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.

    Data was collected at a single time point for each condition. Conditions occurred within a two week time period.

Secondary Outcomes (5)

  • Velocity as Measured by the Gaitrite Walk-way System.

    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.

    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.

    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.

    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.

    Data was collected at a single time point for each condition. Conditions occurred within a two week time period.

Study Arms (2)

Auditory cueing at self paced cadence

ACTIVE COMPARATOR

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

Device: Auditory Cueing

Cueing at 20% above self paced cadence

EXPERIMENTAL

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

Device: Auditory Cueing

Interventions

Auditory cueing set at different frequency rates

Auditory cueing at self paced cadenceCueing at 20% above self paced cadence

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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®.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 12234229BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 22142756BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title
Joanne Lindop
Organization
University College London

Study Officials

  • Melissa Walk-ley

    University College, London

    PRINCIPAL INVESTIGATOR
  • Ann Lyons, PHD

    Northumberia University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 28, 2016

Study Start

April 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

August 31, 2016

Results First Posted

August 31, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share