Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-01-07 @ 4:30 AM
Study NCT ID:
NCT02666560
Status:
COMPLETED
Last Update Posted:
2016-08-31
First Post:
2016-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Does Increasing Auditory Cueing Affect Gait Parameters in Children With Cerebral Palsy During a Functional Task?
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joanne.lindop.12@ucl.ac.uk', 'phone': '07909116145', 'title': 'Joanne Lindop', 'organization': 'University College London'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Two months on completion of the study', 'description': 'All the participants were followed up during the routine physiotherapy review appointments upon completion of the study. No adverse events were reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Auditory Cueing at Self Paced Cadence', 'description': 'Participants performed a functional task with auditory cueing set at self paced cadence.\n\nAuditory Cueing: Auditory cueing set at different frequency rates', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cueing at 20% Above Self Paced Cadence', 'description': 'Participants performed a functional task with auditory cueing set at 20% above self paced cadence whilst performing a functional task.\n\nAuditory Cueing: Auditory cueing set at different frequency rates', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Step Length as Measured by the Gaitrite Walk-way System.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACSC', 'description': 'Auditory cueing at self paced cadence'}, {'id': 'OG001', 'title': 'AC20', 'description': 'Auditory cueing set at 20% above self paced cadence'}], 'classes': [{'categories': [{'measurements': [{'value': '51.32', 'spread': '6.42', 'groupId': 'OG000'}, {'value': '53.36', 'spread': '8.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data was collected at a single time point for each condition. Conditions occurred within a two week time period.', '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.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Velocity as Measured by the Gaitrite Walk-way System.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACSC', 'description': 'Auditory cueing at self paced cadence'}, {'id': 'OG001', 'title': 'AC20', 'description': 'Auditory cueing at 20% above self paced cadence'}], 'classes': [{'categories': [{'measurements': [{'value': '98.62', 'spread': '16.29', 'groupId': 'OG000'}, {'value': '101.77', 'spread': '21.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data was collected at a single time point for each condition. Conditions occurred within a two week time period.', '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.", 'unitOfMeasure': 'cm/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Step Time as Measured by the Gaitrite Walk-way System.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACSC', 'description': 'Auditory cueing at self paced cadence'}, {'id': 'OG001', 'title': 'AC20', 'description': 'Auditory cueing at 20% above self paced cadence'}], 'classes': [{'categories': [{'measurements': [{'value': '0.53', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data was collected at a single time point for each condition. Conditions occurred within a two week time period.', '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.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cadence as Measured by the Gaitrite Walk-way System.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACSC', 'description': 'Auditory cueing at self paced cadence'}, {'id': 'OG001', 'title': 'AC20', 'description': 'Auditory cueing at 20% above self paced cadence'}], 'classes': [{'categories': [{'measurements': [{'value': '115.27', 'spread': '15.75', 'groupId': 'OG000'}, {'value': '117.09', 'spread': '15.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data was collected at a single time point for each condition. Conditions occurred within a two week time period.', '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.', 'unitOfMeasure': 'steps per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time Spent in Double Support as Measured by the Gaitrite Walk-way System.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACSC', 'description': 'Auditory cueing at self paced cadence'}, {'id': 'OG001', 'title': 'AC20', 'description': 'Auditory cueing at 20% above self paced cadence'}], 'classes': [{'categories': [{'measurements': [{'value': '0.30', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data was collected at a single time point for each condition. Conditions occurred within a two week time period.', '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 (%).', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time Spent in Single Support as Measured by the Gaitrite Walk-way System.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACSC', 'description': 'Auditory cueing at self paced cadence'}, {'id': 'OG001', 'title': 'AC20', 'description': 'Auditory cueing at 20% above self paced cadence'}], 'classes': [{'categories': [{'measurements': [{'value': '0.38', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data was collected at a single time point for each condition. Conditions occurred within a two week time period.', '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 (%).', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cueing Self Paced Then Cueing 20% Above Self Paced Cadence', 'description': "Participants performed a functional task with auditory cueing set at self paced cadence. Five days following participants performed a functional task with auditory cueing set at 20% above self paced cadence.\n\nAuditory Cueing: This was was delivered by a metronome, which was set at a beat frequency rate that matched the participant's baseline cadence or 20% above baseline cadence."}, {'id': 'FG001', 'title': 'Cueing at 20% Above Self Paced Cadence Then Self Based Cadence', 'description': "Participants performed a functional task with auditory cueing set at 20% above self paced cadence. Five days following participants performed a functional task with auditory cueing set at self paced cadence.\n\nAuditory Cueing: This was delivered by a metronome, which was set at a beat frequency rate 20% above baseline cadence or that matched the participant's baseline cadence."}], 'periods': [{'title': 'Condition 1 (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Condition 2 (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': "Participants performed a functional task with auditory cueing set at self paced cadence and 20% above self paced cadence.\n\nAuditory Cueing: This was delivered by a metronome producing a beat which was set at the participant's baseline cadence or 20% above baseline cadence.\n\nThis was a crossover design where participants completed both arms in the trial."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '104.3', 'spread': '25.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-04', 'studyFirstSubmitDate': '2016-01-07', 'resultsFirstSubmitDate': '2016-04-18', 'studyFirstSubmitQcDate': '2016-01-25', 'lastUpdatePostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-08-04', 'studyFirstPostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Step Length as Measured by the Gaitrite Walk-way System.', 'timeFrame': 'Data was collected at a single time point for each condition. Conditions occurred within a two week time period.', '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.'}], 'secondaryOutcomes': [{'measure': 'Velocity as Measured by the Gaitrite Walk-way System.', 'timeFrame': 'Data was collected at a single time point for each condition. Conditions occurred within a two week time period.', '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."}, {'measure': 'Step Time as Measured by the Gaitrite Walk-way System.', 'timeFrame': 'Data was collected at a single time point for each condition. Conditions occurred within a two week time period.', '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.'}, {'measure': 'Cadence as Measured by the Gaitrite Walk-way System.', 'timeFrame': 'Data was collected at a single time point for each condition. Conditions occurred within a two week time period.', '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.'}, {'measure': 'Time Spent in Double Support as Measured by the Gaitrite Walk-way System.', 'timeFrame': 'Data was collected at a single time point for each condition. Conditions occurred within a two week time period.', '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 (%).'}, {'measure': 'Time Spent in Single Support as Measured by the Gaitrite Walk-way System.', 'timeFrame': 'Data was collected at a single time point for each condition. Conditions occurred within a two week time period.', '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 (%).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Auditory Cueing', 'Gait'], 'conditions': ['Cerebral Palsy', 'Children']}, 'referencesModule': {'references': [{'pmid': '12234229', 'type': 'BACKGROUND', '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.'}, {'type': '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.'}, {'pmid': '22142756', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAim: To explore if increasing auditory cueing frequency (AC20) affects gait during a functional task compared to auditory cueing at self-paced cadence (ACSC).\n\nMethod: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Cognitive status average or above on the Weschler Intelligence Scale for children.\n* Able to hear without the use of a hearing aid.\n\nExclusion Criteria:\n\n* Hearing impairment that results in the use of a hearing aid.\n* Walking with assistance of a mobility aid.\n* Cardiovascular problems or other associated health problems which limits the child waking multiple times over the GAITRite®.'}, 'identificationModule': {'nctId': 'NCT02666560', 'briefTitle': 'Does Increasing Auditory Cueing Affect Gait Parameters in Children With Cerebral Palsy During a Functional Task?', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Child Health'}, 'officialTitle': 'Does Increasing Auditory Cueing Affect Gait Parameters in Children With Cerebral Palsy During a Functional Task?', 'orgStudyIdInfo': {'id': '141A22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Auditory cueing at self paced cadence', 'description': 'Participants performed a functional task with auditory cueing set at self paced cadence.', 'interventionNames': ['Device: Auditory Cueing']}, {'type': 'EXPERIMENTAL', 'label': 'Cueing at 20% above self paced cadence', 'description': 'Participants performed a functional task with auditory cueing set at 20% above self paced cadence whilst performing a functional task.', 'interventionNames': ['Device: Auditory Cueing']}], 'interventions': [{'name': 'Auditory Cueing', 'type': 'DEVICE', 'description': 'Auditory cueing set at different frequency rates', 'armGroupLabels': ['Auditory cueing at self paced cadence', 'Cueing at 20% above self paced cadence']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Melissa Walk-ley', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College, London'}, {'name': 'Ann Lyons, PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'Northumberia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Child Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gateshead Health NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}