Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-01-27 @ 1:12 AM
Study NCT ID:
NCT07212205
Status:
COMPLETED
Last Update Posted:
2025-10-08
First Post:
2025-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Freezing in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': "Arm 1: PDF (Parkinson's Disease with Freezing of Gait)\n\nIntervention: Visual \\& Auditory Cueing Walker\n\nDescription: Participants were assessed under two within-subject conditions: walking without cues and walking with a visual \\& auditory cueing walker.\n\nArm 2: PDNF (Parkinson's Disease without Freezing of Gait)\n\nIntervention: Visual \\& Auditory Cueing Walker\n\nDescription: Participants were assessed under two within-subject conditions: walking without cues and walking with a visual \\& auditory cueing walker.\n\nThis is a non-randomized interventional study with two parallel groups (PDF and PDNF). Each participant was assessed under two within-subject conditions: walking without cues and walking with a visual and auditory cueing walker. The two conditions are repeated measures within each arm"}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2023-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2025-09-30', 'studyFirstSubmitQcDate': '2025-09-30', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gait Adaptation', 'timeFrame': 'Immediately after walking with the visual and auditory cueing walker test was completed', 'description': 'Dynamic Gait Index: Time taken by the participant to complete the 7-meter walking path under each condition (without cues and with visual \\& auditory cueing walker), measured using the Timed Up and Go Test (TUGT).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Auditory and Visual cue', 'Gait', "Parkinson's disease", 'Walker'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to investigate the effects of a visual and auditory cueing walker on freezing of gait during walking in patients with Parkinson\\'s disease (PDF), compared to Parkinson patients without freezing of gait (PDNF).Sample size was calculated to detect a difference of 0.37 m/sec on mean velocity, with a deviation of 0.3 m/sec, two-sided 5% significance level, and power of 90%. Considering the expected 10% dropout rate, twelve subjects were included.Researcher R1 determined whether the subject was eligible for inclusion in the trial and researcher R2 carried out the gait analysis. Both examiners were unaware of group allocation. An independent researcher (R3) performed the clinical evaluation before the procedures started. Participants walked back and forth on a 7-meter walking path under two different conditions: without cues and with a walker providing visual and auditory cues. To assess the risk of falls in both groups, the \\"Tinetti Balance and Gait Assessment\\" was conducted. Additionally, the \\"Dynamic Gait Index\\" was used to evaluate the ability to adapt walking to varying task demands, and the Timed Up and Go Test (TUGT) was employed to determine walking speed.', 'detailedDescription': 'This study suggests that a walker providing visual and auditory cues may improve daily walking in patients with Parkinson\\'s disease with freezing of gait (PDF) and reduce the risk of falls in patients with Parkinson\\'s disease without freezing of gait (PDNF) who exhibit hypokinetic gait patterns.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:Those with a Hoehn-Yahr classification between 2.5 and 4 were included in the study.\n\n\\-\n\nExclusion Criteria:Patients with secondary parkinsonism, severe systemic diseases, psychiatric illness, cognitive impairment (Mini-Mental State Examination score \\<24), hearing and vision loss, musculoskeletal problems, or symptoms suggestive of cerebellar dysfunction were excluded from the study.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07212205', 'acronym': 'parkinson', 'briefTitle': "Freezing in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Necmettin Erbakan University'}, 'officialTitle': "The Effect of Visual and Auditory Cueing Walker on Gait in Individuals With Parkinson's Disease Experiencing Freezing of Gait", 'orgStudyIdInfo': {'id': 'nezahat keleşoğlu'}, 'secondaryIdInfos': [{'id': 'Necmettin Erbakan university', 'type': 'OTHER', 'domain': 'The Scientific and Technological Research Council of Turkey'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "PDF (Parkinson's Disease with Freezing of Gait)", 'description': 'Intervention Name: Visual \\& Auditory Cueing Walker\n\nDescription:\n\n"Participants in this arm were assessed under two within-subject conditions: walking on a 7-meter path without cues (control condition) and walking on the same path using a visual and auditory cueing walker (intervention condition). Each participant completed both conditions in a single session. Pre- and post-walking evaluations were conducted for walking speed (Timed Up and Go Test), fall risk (Tinetti Balance and Gait Assessment), and gait adaptation (Dynamic Gait Index). The \'no cues\' condition represents a repeated-measures control within the same arm. Participants were included based on the presence of freezing of gait."\n\nPlanned Enrollment: 18', 'interventionNames': ['Other: Visual & Auditory Cueing Walker']}, {'type': 'EXPERIMENTAL', 'label': "PDNF (Parkinson's Disease without Freezing of Gait)", 'description': 'Intervention Name: Visual \\& Auditory Cueing Walker\n\nDescription:\n\n"Participants in this arm were assessed under two within-subject conditions: walking on a 7-meter path without cues (control condition) and walking on the same path using a visual and auditory cueing walker (intervention condition). Each participant completed both conditions in a single session. Pre- and post-walking evaluations were conducted for walking speed (Timed Up and Go Test), fall risk (Tinetti Balance and Gait Assessment), and gait adaptation (Dynamic Gait Index). The \'no cues\' condition represents a repeated-measures control within the same arm. Participants were included based on the absence of freezing of gait."\n\nPlanned Enrollment: 12', 'interventionNames': ['Other: Visual & Auditory Cueing Walker']}], 'interventions': [{'name': 'Visual & Auditory Cueing Walker', 'type': 'OTHER', 'description': 'Intervention Name:\n\nVisual \\& Auditory Cueing Walker\n\nOther Intervention Names (varsa):\n\nCueing Walker Walker with Visual \\& Auditory Cues\n\nIntervention Description:\n\n"Participants in this arm were assessed under two within-subject conditions: walking on a 7-meter path without cues (control condition) and walking on the same path using a visual and auditory cueing walker (intervention condition). Each participant completed both conditions in a single session. Pre- and post-walking evaluations were conducted for walking speed (Timed Up and Go Test), fall risk (Tinetti Balance and Gait Assessment), and gait adaptation (Dynamic Gait Index). The \'no cues\' condition represents a repeated-measures control within the same arm. Participants were included based on the presence of freezing of gait."\n\nPlanned Enrollment: 18', 'armGroupLabels': ["PDF (Parkinson's Disease with Freezing of Gait)", "PDNF (Parkinson's Disease without Freezing of Gait)"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '40336', 'city': 'Konya', 'state': 'Meram', 'country': 'Turkey (Türkiye)', 'facility': 'Nezahat Keleşoğlu Faculty of Health Sciences', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}, {'zip': '40690', 'city': 'Konya', 'state': 'Meram', 'country': 'Turkey (Türkiye)', 'facility': 'Necmettin Erbakan University', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared due to participant privacy and confidentiality concerns, as well as institutional regulations governing sensitive patient information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Necmettin Erbakan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst. Prof.', 'investigatorFullName': 'Neslihan Altuntas Yilmaz', 'investigatorAffiliation': 'Necmettin Erbakan University'}}}}