Cerebral PalsyNCT02666560
Does Increasing Auditory Cueing Affect Gait Parameters in Children With Cerebral Palsy During a Functional Task?
A study testing Auditory Cueing in people with Cerebral Palsy and Children, run by Institute of Child Health.
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. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Cerebral Palsy, Children
- What is being tested?
- Auditory Cueing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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®.
About this study
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.
- Conditions
- Cerebral Palsy, Children
- Being tested
- Auditory Cueing
- Keywords
- Auditory Cueing, Gait
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory CueingDevice
Auditory cueing set at different frequency rates
| Study group | Role | What they receive |
|---|---|---|
| Auditory cueing at self paced cadence | Active comparator | Participants performed a functional task with auditory cueing set at self paced cadence. Receives: 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. Receives: Device: Auditory Cueing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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 (%).
Measured: 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.
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 (%).
Measured: Data was collected at a single time point for each condition. Conditions occurred within a two week time period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startApr 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Child Health
- Sponsor type
- University, hospital or other
- Collaborators
- Gateshead Health NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Melissa Walk-ley, Principal investigator, University College, LondonAnn Lyons, PHD, Study chair, Northumberia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666560
- Sponsor's protocol ID
- 141A22
- Status last verified
- Apr 2016
- First submitted
- 7 Jan 2016
- Last updated
- 31 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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 12234229Kwak, 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Increasing Auditory Cueing Affect Gait Parameters in Children With Cerebral Palsy During a Functional Task?
- ClinicalTrials.gov ID
- NCT02666560
- Acronym / sponsor ID
- 141A22
- Conditions
- Cerebral Palsy, Children
- Keywords
- Auditory Cueing, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Institute of Child HealthUniversity, hospital or other
- Collaborators
- Gateshead Health NHS Foundation Trust
- Study start
- Apr 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Posted 31 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auditory cueing at self paced cadence | Active comparator | Device: Auditory CueingParticipants performed a functional task with auditory cueing set at self paced cadence. |
| Cueing at 20% above self paced cadence | Experimental | Device: Auditory CueingParticipants performed a functional task with auditory cueing set at 20% above self paced cadence whilst performing a functional task. |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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®.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auditory CueingAuditory cueing set at different frequency rates | Device | Auditory cueing at self paced cadence, Cueing at 20% above self paced cadence |
Primary outcome
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.
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12234229Rosenbaum 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.
- BackgroundKwak, 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: PubMed 22142756Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Walk-ley principal investigator
University College, London
Ann Lyons, PHD study chair
Northumberia University
Questions about this trial
What is this clinical trial studying?
A study testing Auditory Cueing in people with Cerebral Palsy and Children, run by Institute of Child Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02666560, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2016.