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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02666560
Other study ID # 141A22
Secondary ID
Status Completed
Phase N/A
First received January 7, 2016
Last updated January 25, 2016
Start date April 2015
Est. completion date May 2015

Study information

Verified date January 2016
Source Institute of Child Health
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 11 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Auditory Cueing
Auditory cueing set at different frequency rates

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Institute of Child Health Gateshead Health NHS Foundation Trust

References & Publications (3)

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. — View 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.

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of auditory cueing on the gait temporal-spatial parameter of step length as measured by the Gaitrite walk-way system in children with cerebral palsy 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. 2weeks No
Secondary Effect of auditory cueing on the gait temporal-spatial parameter of velocity as measured by the Gaitrite walk-way system in children with cerebral palsy 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. 2weeks No
Secondary Effect of auditory cueing on the gait temporal-spatial parameter of step time as measured by the Gaitrite walk-way system in children with cerebral palsy 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. 2weeks No
Secondary Effect of auditory cueing on the gait temporal-spatial parameter of cadence as measured by the Gaitrite walk-way system in children with cerebral palsy 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. 2weeks No
Secondary Effect of auditory cueing on the gait temporal-spatial parameter of time spent in double support as measured by the Gaitrite walk-way system in children with cerebral palsy The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of time spent in double support was recorded in percentage. 2weeks No
Secondary Effect of auditory cueing on the gait temporal-spatial parameter of time spent in single support as measured by the Gaitrite walk-way system in children with cerebral palsy The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of time spent in single support was recorded in percentage. 2weeks No
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