Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-25 @ 1:26 PM
Study NCT ID:
NCT04459559
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2020-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Usability of a Novel Cueing Device for Patients With 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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The proposed trial is designed as an explorative, open label, non-randomised, uncontrolled clinical trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-11', 'studyFirstSubmitDate': '2020-06-11', 'studyFirstSubmitQcDate': '2020-07-03', 'lastUpdatePostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Setup cueing device', 'timeFrame': '2 weeks', 'description': 'Time needed for the setup \\[in seconds\\] and the variations of the different setup parameters (cueing length \\[seconds\\], cueing strength \\[% of maximum\\], cueing cadence \\[count/minutes\\]) between the days of usage. Overall descriptive summary of the variation between the different setup parameters during the days of usage.'}, {'measure': 'System Usability Scale', 'timeFrame': '2 weeks', 'description': "Items defined by the System Usability Scale: 5-point Likert scale ('strongly disagree' to 'strongly agree')."}, {'measure': 'Usability', 'timeFrame': '2 weeks', 'description': 'Usability of the cueing device is measured by a self-developed questionnaire.'}, {'measure': 'Acceptance', 'timeFrame': '2 weeks', 'description': 'Acceptance is measured by a self-developed questionnaire.'}, {'measure': 'Frequency using the device', 'timeFrame': '2 weeks', 'description': 'How often the device is used (counts logging protocol).'}], 'secondaryOutcomes': [{'measure': 'Walking speed [meters/second]', 'timeFrame': '1 week', 'description': 'Calculated by the assessments 10 meter walk test and 2-minute walk test.'}, {'measure': 'Cadence [steps/minute]', 'timeFrame': '1 week', 'description': 'Number during 10 meter walk test. Also measured by a system of movement analysis (C-Mill MOTEK).'}, {'measure': 'Walking distance [in meters]', 'timeFrame': '1 week', 'description': 'Measured by a digital measuring wheel during 2-minute walk test. Also measured by a system of movement analysis (C-Mill MOTEK).'}, {'measure': 'Step length right/left [in meters]', 'timeFrame': '1 week', 'description': 'Measured by a system of movement analysis (C-Mill MOTEK).'}, {'measure': 'Initial step latency [in seconds]', 'timeFrame': '1 week', 'description': 'Extracted from video documentation by a blinded rater.'}, {'measure': 'Number of FOG', 'timeFrame': '1 week', 'description': 'Extracted from video documentation by a blinded rater.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Freezing of Gait', 'Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '19906597', 'type': 'BACKGROUND', 'citation': "Bachlin M, Plotnik M, Roggen D, Maidan I, Hausdorff JM, Giladi N, Troster G. Wearable assistant for Parkinson's disease patients with the freezing of gait symptom. IEEE Trans Inf Technol Biomed. 2010 Mar;14(2):436-46. doi: 10.1109/TITB.2009.2036165. Epub 2009 Nov 10."}, {'pmid': '17988925', 'type': 'BACKGROUND', 'citation': "Baker K, Rochester L, Nieuwboer A. The effect of cues on gait variability--reducing the attentional cost of walking in people with Parkinson's disease. Parkinsonism Relat Disord. 2008;14(4):314-20. doi: 10.1016/j.parkreldis.2007.09.008. Epub 2007 Nov 7."}, {'pmid': '18668629', 'type': 'BACKGROUND', 'citation': 'Giladi N, Nieuwboer A. Understanding and treating freezing of gait in parkinsonism, proposed working definition, and setting the stage. Mov Disord. 2008;23 Suppl 2:S423-5. doi: 10.1002/mds.21927. No abstract available.'}]}, 'descriptionModule': {'briefSummary': "Hypokinetic gait disorder and Freezing of Gait (FOG) are frequent symptoms in the advanced stage of Parkinson's disease (PD). These impair quality of life and significantly increase the risk of falls. External movement pacemakers have been developed to improve gait and avert FOG by cueing strategies. The investigators developed a smart, small and lightweight, easy-to-handle wearable tactile cueing device (TCD), consisting of a control unit, two pulse generators and a battery-driven power supply. The device is programmed via a Graphical User Interface (GUI)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Include patients who suffer from advanced PD. Characteristic symptoms of parkinsonian gait like hypokinetic movements and/or FOG have to be present.\n* Parkinsonian gait is measured by the following items of the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS): item 2.12, item 2.13, item 3.10 and item 3.11. The Hoehn and Yahr (HY) stage during ON is 1-4/5.\n* MoCA ≥ 22/30.\n* Participant has signed the informed consent.\n\nExclusion Criteria:\n\n* Inability of the participant to understand the IC or to follow the procedures of the study (as judged by the Qualified Physician).\n* Significantly, impaired cognitive skills render the participant unable to use the TCD.\n* Presence of severe motor fluctuations and severely impaired walking ability as defined by HY stage V during ON.\n* Clinically relevant skin lesions on the wrist or fixation points (usually the thighs).'}, 'identificationModule': {'nctId': 'NCT04459559', 'acronym': 'TCP', 'briefTitle': "Usability of a Novel Cueing Device for Patients With Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Swiss Federal Institute of Technology'}, 'officialTitle': "Usability Study of a Novel Tactile Cueing Device for Patients With Parkinson's Disease: A Monocentric Interventional Study", 'orgStudyIdInfo': {'id': 'RZS_01_2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Using the Tactile Cueing Device', 'interventionNames': ['Device: Tactile Cueing Device']}], 'interventions': [{'name': 'Tactile Cueing Device', 'type': 'DEVICE', 'description': "Each participant receives an individual training on how to use the Tactile Cueing Device and the set-up of the TCD will be done according to the results of a 10MWT and the participant's preferences. Gait assessments with an activated or deactivated TCD are executed using the Timed Up and Go test, the 2-Minute Waling test and a treadmill (C-Mill). Also a long-term test run of the TCD during one day is planned.", 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8588', 'city': 'Zihlschlacht', 'state': 'Thurgau', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Raoul Schweinfurther, M.A. Sport Science', 'role': 'CONTACT', 'email': 'R.Schweinfurther@rehaklinik-zihlschlacht.ch', 'phone': '+41 71 424 3118'}], 'facility': 'Rehaklinik Zihlschlacht AG', 'geoPoint': {'lat': 47.52065, 'lon': 9.25736}}], 'centralContacts': [{'name': 'Raoul Schweinfurther, M.A.', 'role': 'CONTACT', 'email': 'r.schweinfurther@rehaklinik-zihlschlacht.ch', 'phone': '+41 71 424 3118'}, {'name': 'Carsten Möller, Prof.', 'role': 'CONTACT', 'email': 'C.Moeller@rehaklinik-zihlschlacht.ch', 'phone': '+41 71 424 3021'}], 'overallOfficials': [{'name': 'Raoul Schweinfurther, M.A.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rehaklinik Zihlschlacht AG'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Federal Institute of Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rehaklinik Zihlschlacht AG', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}