CClinicalTrials.gg
CompletedNCT02666560Updated Aug 31, 2016Results posted

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

An interventional study of Auditory Cueing in Cerebral Palsy and Children, sponsored by Institute of Child Health. Completed. Open to participants aged 5 Years to 11 Years. Per ClinicalTrials.gov, last updated 2016-08-31.

Sponsored by Institute of Child Health · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
5 Years to 11 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cerebral Palsy
  • Children

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Keywords

  • Auditory Cueing
  • Gait
03

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.

This study's enrollment of 19 is below the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Institute of Child Health is the lead sponsor of 40 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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®.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
19 participants (actual)

Study arms

  • Active comparator
    Auditory cueing at self paced cadence

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

    Device: Auditory Cueing

  • 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

Interventions

  • DeviceAuditory Cueing

    Auditory cueing set at different frequency rates

06

What researchers measure

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.

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

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

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

  5. 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 (%).

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

07

Results

Posted Aug 31, 2016

Participant flow

Recruitment occurred at an NHS FoundationTrust between March to April 2015. Twenty-six children with Cerebral Palsy who were currently on the paediatric physiotherapy caseload met the inclusion criteria, so were invited to participate. A total of nineteen children chose to participate in this research project.

Condition 1 (1 Day)
Participant flow — Condition 1 (1 Day)
MilestoneCueing Self Paced Then Cueing 20% Above Self Paced CadenceCueing at 20% Above Self Paced Cadence Then Self Based Cadence
Started811
Completed811
Not completed00
Condition 2 (1 Day)
Participant flow — Condition 2 (1 Day)
MilestoneCueing Self Paced Then Cueing 20% Above Self Paced CadenceCueing at 20% Above Self Paced Cadence Then Self Based Cadence
Started811
Completed811
Not completed00

Outcome measures

PrimaryStep 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.

Time frame:
Data was collected at a single time point for each condition. Conditions occurred within a two week time period.
Reported as:
Mean · cm
Step Length as Measured by the Gaitrite Walk-way System.
cmACSCAC20
Step Length as Measured by the Gaitrite Walk-way System.51.32 ± 6.4253.36 ± 8.07
SecondaryVelocity 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.

Time frame:
Data was collected at a single time point for each condition. Conditions occurred within a two week time period.
Reported as:
Mean · cm/s
Velocity as Measured by the Gaitrite Walk-way System.
cm/sACSCAC20
Velocity as Measured by the Gaitrite Walk-way System.98.62 ± 16.29101.77 ± 21.08
SecondaryStep 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.

Time frame:
Data was collected at a single time point for each condition. Conditions occurred within a two week time period.
Reported as:
Mean · seconds
Step Time as Measured by the Gaitrite Walk-way System.
secondsACSCAC20
Step Time as Measured by the Gaitrite Walk-way System.0.53 ± 0.090.52 ± 0.08
SecondaryCadence 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 frame:
Data was collected at a single time point for each condition. Conditions occurred within a two week time period.
Reported as:
Mean · steps per minute
Cadence as Measured by the Gaitrite Walk-way System.
steps per minuteACSCAC20
Cadence as Measured by the Gaitrite Walk-way System.115.27 ± 15.75117.09 ± 15.97
SecondaryTime 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 frame:
Data was collected at a single time point for each condition. Conditions occurred within a two week time period.
Reported as:
Mean · percentage of time
Time Spent in Double Support as Measured by the Gaitrite Walk-way System.
percentage of timeACSCAC20
Time Spent in Double Support as Measured by the Gaitrite Walk-way System.0.30 ± 0.910.29 ± 0.09
SecondaryTime 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 (%).

Time frame:
Data was collected at a single time point for each condition. Conditions occurred within a two week time period.
Reported as:
Mean · percentage of time
Time Spent in Single Support as Measured by the Gaitrite Walk-way System.
percentage of timeACSCAC20
Time Spent in Single Support as Measured by the Gaitrite Walk-way System.0.38 ± 0.050.39 ± 0.05

Adverse events

Collected over Two months on completion of the study. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Auditory Cueing at Self Paced Cadence—0/19 (0%)0/19 (0%)
Cueing at 20% Above Self Paced Cadence—0/19 (0%)0/19 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)All Study Participants
<=18 years19
Between 18 and 65 years0
>=65 years0
Age, Continuous
Age, Continuous(months)All Study Participants
Mean104.3 ± 25.5
Sex: Female, Male
Sex: Female, Male(Participants)All Study Participants
Female11
Male8
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • 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. PubMed 12234229 ↗
  • 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.
  • 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. PubMed 22142756 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02666560
Lead sponsor
Institute of Child Health
Collaborators
Gateshead Health NHS Foundation Trust
Responsible party
Sponsor
First posted
Jan 28, 2016
Start date
Apr 2015
Primary completion
May 2015
Completion
May 2015
Results posted
Aug 31, 2016
Last update
Aug 31, 2016

Study contacts

Melissa Walk-ley
principal investigator · University College, London
Ann Lyons, PHD
study chair · Northumberia University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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