Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 5:38 AM
Study NCT ID:
NCT07281794
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-22
First Post:
2025-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Validity of the DANU Sports System for Gait and Balance Assessment 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-09-16', 'studyFirstSubmitQcDate': '2025-12-01', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Double Support Time', 'timeFrame': 'Outcomes will be obtained in one visit (Day 1).', 'description': '(s, mean ± standard deviation)'}, {'measure': 'Single Support Time', 'timeFrame': 'Outcomes will be obtained in one visit (Day 1).', 'description': '(s, mean ± standard deviation'}], 'primaryOutcomes': [{'measure': 'Stride Length', 'timeFrame': 'Outcomes will be obtained in one visit (Day 1).', 'description': '(m, mean ± standard deviation)'}, {'measure': 'Step Time', 'timeFrame': 'Outcomes will be obtained in one visit (Day 1).', 'description': '(s, mean ± standard deviation)'}, {'measure': 'Stride Time', 'timeFrame': 'Outcomes will be obtained in one visit (Day 1).', 'description': '(s, mean ± standard deviation)'}, {'measure': 'Cadence', 'timeFrame': 'Outcomes will be obtained in one visit (Day 1).', 'description': '(steps per minute, mean ± standard deviation)'}, {'measure': 'Ground Contact Time', 'timeFrame': 'Outcomes will be obtained in one visit (Day 1).', 'description': '(s, mean ± standard deviation)'}, {'measure': 'Swing Time', 'timeFrame': 'Outcomes will be obtained in one visit (Day 1).', 'description': '(s, mean ± standard deviation)'}, {'measure': 'Stride Velocity', 'timeFrame': 'Outcomes will be obtained in one visit (Day 1).', 'description': '(m/s, mean ± standard deviation)'}, {'measure': 'Gait Velocity', 'timeFrame': 'Outcomes will be obtained in one visit (Day 1).', 'description': '(m/s, mean ± standard deviation)'}, {'measure': 'Area of Ellipse', 'timeFrame': 'Outcomes will be obtained in one visit (Day 1).', 'description': '(mm², mean ± standard deviation)'}, {'measure': 'Length of Ellipse', 'timeFrame': 'Outcomes will be obtained in one visit (Day 1).', 'description': '(mm, mean ± standard deviation)'}, {'measure': 'Width of Ellipse', 'timeFrame': 'Outcomes will be obtained in one visit (Day 1).', 'description': '(mm, mean ± standard deviation)'}, {'measure': 'Total Displacement', 'timeFrame': 'Outcomes will be obtained in one visit (Day 1).', 'description': '(mm, mean ± standard deviation)'}, {'measure': 'Medio-Lateral Range', 'timeFrame': 'Outcomes will be obtained in one visit (Day 1).', 'description': '(mm, mean ± standard deviation)'}, {'measure': 'Anterior-Posterior Range', 'timeFrame': 'Outcomes will be obtained in one visit (Day 1).', 'description': '(mm, mean ± standard deviation)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DANU', 'Clinical Validation', 'Wearable Electronic Devices'], 'conditions': ['Parkinson Disease (PD)', 'Healthy (Controls)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.danumedical.com/', 'label': 'DANU Medical Website: Study Collaborator and Smart Sock System.'}]}, 'descriptionModule': {'briefSummary': "This observational study aims to explore the use of the DANU Smart Socks for gait and balance assessment in people with Parkinson's (PwP). The study will compare walking and balance outcomes produced by DANU from people with Parkinson's (PwP) and a group of healthy individuals of similar age. The project aims to investigate if the gait and balance data collected are linked to measures of Parkinson's symptoms such as disease progression and cognitive abilities. Gait and balance outcomes will be obtained through one observational laboratory visit.", 'detailedDescription': "Methods:\n\nInstitutional ethics have been obtained (Project ID: 8543). Utilising an observational design, participants will be asked to attend one visit to Northumbria University, Newcastle Upon Tyne.\n\nVisit 1: Participants will complete a series of clinical and cognitive measures including the Movement Disorders Society's-Unified Parkinson's Disease Rating Scale, Montreal Cognitive Assessment, Freezing of Gait Questionnaire and Falls Efficacy Scale to act as descriptive measures. Following this, the investigators will conduct a concurrent data collection throughout a battery of motor tasks. The DANU system will be used alongside APDM Mobility Lab throughout the full duration of data collection. Mobility assessments include a 2-Minute Walk Test, 3 walkway trials, a Timed Up and Go and a series of 2-Minute Balance tasks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be recruited if they fulfill the exclaimed participation criteria and are located within the North East of England. Participants will be recruited from our existing laboratory database, word of mouth and through visiting local groups.', 'healthyVolunteers': True, 'eligibilityCriteria': "Parkinson's Group Inclusion Criteria:- Clinical diagnosis of Parkinson's by a movement disorder specialist according to UK brain bank criteria.\n\n* PD stages I-III (Hoehn and Yahr Rating Scale)\n* Able to attend Northumbria University, Newcastle Upon Tyne for study visits.\n* Able to walk and stand unassisted for a minimum of 2-minutes.\n* Aged 50 years old or over\n\nParkinson's Group Exclusion Criteria:\n\n* History of neurological disorders other than PD (e.g., Huntington's disease, stroke, traumatic brain injury, multiple sclerosis, Alzheimer's disease etc.)\n* Unable to walk or stand unaided.\n* Montreal Cognitive Assessment (MoCA) score \\< 21\n* Significant issues unrelated to PD that may affect gait (e.g., musculoskeletal issues, back pain, recent surgery etc.)\n\nHealthy Control Inclusion Criteria:\n\n* Ability to attend Northumbria University, Newcastle Upon Tyne for study visits.\n* Aged 50 years old or over.\n* Able to walk and stand unassisted for a minimum of 2-minutes.\n\nHealthy Control Exclusion Criteria:\n\n* History of neurological disorders (e.g. Huntington's disease, stroke, traumatic brain injury, multiple sclerosis, Alzheimer's disease etc.)\n* Significant issues that may affect walking (e.g., musculoskeletal issues, back pain, recent surgery etc.)"}, 'identificationModule': {'nctId': 'NCT07281794', 'briefTitle': "Clinical Validity of the DANU Sports System for Gait and Balance Assessment in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Northumbria University'}, 'officialTitle': "Clinical Validity of the DANU Sports System for Gait and Balance Assessment in Parkinson's Disease", 'orgStudyIdInfo': {'id': '8543b'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Parkinson's Disease (PD)", 'description': "Participants with a clinical diagnosis of Parkinson's Disease meeting the described eligibility criteria will be recruited to take part within this study. The aim is to recruit 60 people with Parkinson's."}, {'label': 'Healthy Control (HC)', 'description': 'Aged-matched (over 50 years old) healthy controls who meet the described eligibility criteria will be recruited to participate in this study. The aim is to recruit 60 participants.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Northumbria University', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Rodrigo Vitorio, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northumbria University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northumbria University', 'class': 'OTHER'}, 'collaborators': [{'name': 'DANU Sports Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postgraduate Research Student', 'investigatorFullName': 'GabriellaGatti', 'investigatorAffiliation': 'Northumbria University'}}}}