Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-26 @ 1:49 PM
Study NCT ID:
NCT06385392
Status:
COMPLETED
Last Update Posted:
2025-06-22
First Post:
2024-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Wearable Monitor for the Detection and Release of Freezing of Gait.
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-19', 'studyFirstSubmitDate': '2024-04-22', 'studyFirstSubmitQcDate': '2024-04-22', 'lastUpdatePostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To validate the haptic module and insole device system and evaluate its efficacy with an in-community clinical trial.', 'timeFrame': '5 weeks', 'description': 'Change in duration of FOG events. Decreased duration of FOG events indicates higher efficacy of device system.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Freezing of Gait'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "The proposed system (haptic module and insole device) for daily in-community use that detects the occurrence of freezing of gait (FOG) in people with Parkinson's disease (PD). and triggers external cueing stimuli to unfreeze the individual. The purpose of the overall Phase II study is to: (1) Develop a production ready system, (2) Develop a companion mobile app for the proposed system and refine previously developed FOG detection algorithms, and (3) Validate the proper operation of the system and demonstrate its efficacy through lab and in-community testing. This study will focus on validating the system and demonstrating efficacy through in-community testing."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Participants aged 45-80 who have a diagnosis of Parkinson's disease with Freezing of Gait symptoms who live in the community.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to provide and provision of signed and dated informed consent form.\n* Age 45 or older\n* Diagnosis of idiopathic PD, as determined by a movement disorders neurologist in accordance with the PD Society Brain Bank diagnostic criteria.\n* Evidence of presence of freezing gait as a symptom. Determined from combination of clinical examination (observation of freezing) and New Freezing of Gait Questionnaire (NFOG).\n* Able to complete a 2-minute walk test at the pre-treatment visit.\n* Currently on a stable prescription medication regimen for PD and willing to adhere to the regimen during the study.\n* Ability to don and doff the insole and haptic module independently or have daily assistance during the study intervention.\n\nExclusion Criteria:\n\n* Non-English speaking\n* History of musculoskeletal disorders that significantly affect movement of lower limbs as determined at the time of enrollment.\n* Other significant neurological disorders that may affect participation or performance in the study.\n* Neuropathy at the ankle assessed at the pre-treatment visit using the haptic module.\n* Hallucinations\n* Non-ambulatory\n* Legally Blind\n* Symptomatic hypotension\n* Any condition which would limit sensation in the legs or requires use of wraps, bandages or other items which may limit sensation in the legs (e.g., lymphedema) that would interfere with the performance of the haptic device, in the opinion of the investigator.'}, 'identificationModule': {'nctId': 'NCT06385392', 'briefTitle': 'Continuous Wearable Monitor for the Detection and Release of Freezing of Gait.', 'organization': {'class': 'OTHER', 'fullName': 'HealthPartners Institute'}, 'officialTitle': 'Continuous Wearable Monitor for the Detection and Release of Freezing of Gait.', 'orgStudyIdInfo': {'id': 'A23-354'}}, 'armsInterventionsModule': {'armGroups': [{'label': "People with Parkinson's disease and Freezing of Gait using experimental insole and haptic module", 'interventionNames': ['Device: Haptic module and insole device']}], 'interventions': [{'name': 'Haptic module and insole device', 'type': 'DEVICE', 'description': 'System for use in daily in-community use that detects the occurrence of freezing of gait (FOG) and triggers external cueing stimuli to unfreeze the individual.', 'armGroupLabels': ["People with Parkinson's disease and Freezing of Gait using experimental insole and haptic module"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '55427', 'city': 'Golden Valley', 'state': 'Minnesota', 'country': 'United States', 'facility': "Struthers Parkinson's Center", 'geoPoint': {'lat': 45.00969, 'lon': -93.34912}}, {'zip': '55130', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'HealthPartners Neuroscience Center', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'Martha A Nance, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Struthers Parkinson's Center"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HealthPartners Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}