Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-01 @ 12:38 AM
Study NCT ID:
NCT04440033
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2020-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Associated with Falling in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D013060', 'term': 'Speech'}], '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'}, {'id': 'D014705', 'term': 'Verbal Behavior'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Case-control'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-05', 'studyFirstSubmitDate': '2020-06-03', 'studyFirstSubmitQcDate': '2020-06-18', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Age', 'timeFrame': 'baseline', 'description': 'Years since birth'}, {'measure': 'Sex', 'timeFrame': 'baseline', 'description': 'Male or female'}, {'measure': 'Montreal Cognitive Assessment', 'timeFrame': 'baseline', 'description': 'A screening test to assess global cognition (0-30). Higher scores indicate better performance.'}, {'measure': 'Shortened Iconographical Falls Efficacy Scale', 'timeFrame': 'baseline', 'description': 'A 10-item scale to assess fear of falling. Each item is scored on a 4-point scale (1 = not at all concerned to 4 = very concerned).'}, {'measure': 'Fall history', 'timeFrame': 'baseline', 'description': 'Number of falls in the past month'}, {'measure': "Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I", 'timeFrame': 'baseline', 'description': 'A 13-item rating scale to assess non-motor experiences of daily living (0-52). Higher scores indicate a worse outcome.'}, {'measure': "Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III", 'timeFrame': 'baseline', 'description': 'An 18-item motor examination to assess motor symptoms (0-132). Higher scores indicate a worse outcome.'}, {'measure': "Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part IV", 'timeFrame': 'baseline', 'description': 'A 6-item rating scale to assess motor complications. Higher scores indicate a worse outcome.'}, {'measure': 'Hoehn and Yahr scale', 'timeFrame': 'baseline', 'description': 'A scale to assess disease severity/progression (0-5). Higher scores indicate more severe symptoms.'}, {'measure': 'New Freezing of Gait Questionnaire', 'timeFrame': 'baseline', 'description': 'A 9-item questionnaire to assess freezing of gait severity (0-28). Higher scores indicate more severe freezing of gait.'}, {'measure': 'Time since diagnosis', 'timeFrame': 'baseline', 'description': "The number of days since the diagnosis of Parkinson's Disease"}, {'measure': 'Blood pressure', 'timeFrame': 'baseline', 'description': 'The ratio of systolic over diastolic blood pressure (mm Hg)'}, {'measure': 'Medication', 'timeFrame': 'baseline', 'description': 'Number, type and dose (mg) of medication'}], 'primaryOutcomes': [{'measure': 'Fall events', 'timeFrame': 'baseline to 6 months after baseline', 'description': 'Number of accidental falls documented using a daily fall diary with monthly telephone follow-ups.'}], 'secondaryOutcomes': [{'measure': 'Walking speed', 'timeFrame': 'baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment', 'description': 'Walking speed (meters/second) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).'}, {'measure': 'Walking cadence', 'timeFrame': 'baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment', 'description': 'Walking cadence (steps/minute) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).'}, {'measure': 'Step length', 'timeFrame': 'baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment', 'description': 'Step length (meters) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).'}, {'measure': 'Hip, knee and ankle joint angle during walking', 'timeFrame': 'baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment', 'description': 'Hip, knee and ankle joint angle during walking (°) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).'}, {'measure': 'Hip, knee and ankle joint moment during walking', 'timeFrame': 'baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment', 'description': 'Hip, knee and ankle joint moment during walking (Nm/kg) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).'}, {'measure': 'Hip, knee and ankle joint power during walking', 'timeFrame': 'baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment', 'description': 'Hip, knee and ankle joint moment during power (W/kg) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).'}, {'measure': 'Freezing of gait', 'timeFrame': 'baseline during 6 min self-paced treadmill walking in a virtual environment', 'description': 'Number of freezing of gait events measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).'}, {'measure': 'Spontaneous speech production', 'timeFrame': 'baseline; baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment', 'description': 'Audio recordings analyzed using PRAAT software to assess spontaneous speech production'}, {'measure': 'Spontaneous speech production', 'timeFrame': 'baseline; baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment', 'description': 'Audio recordings analyzed using Motor Speech Profile software to assess spontaneous speech production'}, {'measure': 'Speech Handicap Index', 'timeFrame': 'baseline', 'description': 'A 15-item self-reported questionnaire based on the Parole Handicap Index to evaluate the physical, functional and psychosocial impact of dysarthria (0-60). Higher scores indicate a higher level of speech-related problems.'}, {'measure': 'Otoscopy', 'timeFrame': 'baseline', 'description': 'A otoscopic test to examine the external auditory canal and the tympanic membrane'}, {'measure': 'Tympanometry', 'timeFrame': 'baseline', 'description': 'An auditory test to assess the middle-ear function'}, {'measure': 'Pure tone audiometry', 'timeFrame': 'baseline', 'description': 'An auditory test to assess hearing threshold levels'}, {'measure': 'Otoacoustic Emissions Test', 'timeFrame': 'baseline', 'description': 'An auditory test to measure cochlear outer hair cell function'}, {'measure': 'Video Head Impuls Test', 'timeFrame': 'baseline', 'description': 'A vestibular function test to objectify high frequency function of the horizontal and vertical semicircular canals'}, {'measure': 'Cervical Vestibular Evoked Myogenic Potential Testing', 'timeFrame': 'baseline', 'description': 'A vestibular function test to assess the saccular and inferior vestibular nerve function'}, {'measure': 'Ocular Vestibular Evoked Myogenic Potential Testing', 'timeFrame': 'baseline', 'description': 'A vestibular function test to assess the utricular and superior vestibular nerve function'}, {'measure': 'Ocular Motor Testing', 'timeFrame': 'baseline', 'description': 'A vestibular function test to evaluate oculomotor function'}, {'measure': 'Dix-Hallpike Test', 'timeFrame': 'baseline', 'description': 'A diagnostic maneuver to identify benign paroxysmal positional vertigo'}, {'measure': 'Roll Test', 'timeFrame': 'baseline', 'description': 'A diagnostic maneuver to identify benign paroxysmal positional vertigo'}, {'measure': 'Static visual acuity', 'timeFrame': 'baseline', 'description': 'Static visual acuity measured using a Snellen chart (static logMAR)'}, {'measure': 'Dynamic visual acuity', 'timeFrame': 'baseline', 'description': 'Visual acuity during head movement measured using a Snellen chart relative to static visual acuity (static logMAR - dynamic logMAR)'}, {'measure': 'Dizziness Handicap Inventory', 'timeFrame': 'baseline', 'description': 'A 25-item self-assessment inventory to evaluate self-perceived handicapping effects of dizziness (0-100). Higher scores indicate a greater perceived handicap due to dizziness.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's Disease", 'Accidental Falls', 'Risk factor', 'Gait', 'Speech', 'Audiology'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "The objective of this study will be to identify multidisciplinary fall risk factors in persons with stage 3 idiopathic Parkinson's Disease compared to age and sex-matched healthy adults. Both the relative contribution of each independent factor, as well as the interaction between these factors, will be examined. The study will include multidisciplinary assessments, including locomotor, speech, auditory, vestibular and opthalmologic assessments."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Parkinson's Disease group\n\nInclusion criteria:\n\n* Persons with idiopathic PD diagnosed by a medical doctor according to the United Kingdom PD Brain Bank Criteria\n* Aged between 18 and 75 years-old\n* Stage 3 on the Hoehn and Yahr scale in the on-medication state\n* On a stable dose of PD medication (at least one week)\n* Able to stand and walk on a treadmill without support for at least 3 minutes\n* Able to give consent\n\nExclusion criteria:\n\n* Atypical parkinsonism\n* Unpredictable symptom fluctuations\n* Previous surgical management of PD (i.e., deep brain stimulation surgery; pallidotomy)\n* Duodopa pump therapy\n* Dementia (Montreal Cognitive Assessment (MoCA) \\< 21)\\[1\\]\n* Symptomatic orthostatic hypotension (e.g. frequent syncope episodes)\n* Concurrent neurological disorders (e.g. stroke)\n* Comorbidities that affect gait or balance (e.g. peripheral neuropathy)\n* Acute illness\n* Epilepsy or history of seizures\n* Depression (MDS-UPDRS item 1.3 ≥ 2)\n* Body weight over 120 kilograms\n* Pregnancy\n* Participation in other ongoing experimental trials\n\nHealthy control group\n\nInclusion criteria:\n\n* Age and sex-matched healthy adults\n\nExclusion criteria:\n\n* Symptomatic orthostatic hypotension (e.g. frequent syncope episodes)\n* Body weight over 120 kilograms\n* Pregnancy\n* Participation in other ongoing experimental trials"}, 'identificationModule': {'nctId': 'NCT04440033', 'briefTitle': "Factors Associated with Falling in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': "Factors Associated with Falling in Parkinson's Disease: a Multidisciplinary Prospective Study", 'orgStudyIdInfo': {'id': 'BC-07392'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Parkinson's Disease group", 'description': "Patients with stage 3 idiopathic Parkinson's Disease", 'interventionNames': ['Other: Baseline assessment of demographic, anthropometric and clinical characteristics', 'Other: Locomotor assessments', 'Other: Speech assessments', 'Other: Audiology assessments']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy control group', 'description': 'Age and sex-matched healthy adults', 'interventionNames': ['Other: Baseline assessment of demographic, anthropometric and clinical characteristics', 'Other: Locomotor assessments', 'Other: Speech assessments', 'Other: Audiology assessments']}], 'interventions': [{'name': 'Baseline assessment of demographic, anthropometric and clinical characteristics', 'type': 'OTHER', 'description': '* Age\n* Sex\n* Height\n* Body weight\n* Handedness\n* Medication use\n* Blood pressure\n* Global cognition (Montreal Cognitive Assessment)\n* Fear of falling (Shortened Iconographical Falls Efficacy Scale)\n* History of falls (number of falls in the past month)\n* Time since diagnosis and symptom onset\n* Disease severity (UPDRS part III, Hoehn and Yahr)\n* Non-motor symptoms (UPDRS part I)\n* Motor symptoms (UPDRS part III)\n* Motor complications (UPDRS part IV)\n* Disease-dominant side (UPDRS part III)\n* Freezing of gait (New Freezing of Gait Questionnaire)', 'armGroupLabels': ["Parkinson's Disease group"]}, {'name': 'Baseline assessment of demographic, anthropometric and clinical characteristics', 'type': 'OTHER', 'description': '* Age\n* Sex\n* Height\n* Body weight\n* Handedness\n* Medication use\n* Blood pressure\n* Global cognition (Montreal Cognitive Assessment)\n* Fear of falling (Shortened Iconographical Falls Efficacy Scale)\n* History of falls (number of falls in the past month)', 'armGroupLabels': ['Healthy control group']}, {'name': 'Locomotor assessments', 'type': 'OTHER', 'description': 'First, 9 anthropometric measurements will be taken, 39 reflective markers will be placed, and a 6-min practice walking session will be conducted to familiarize participants with self-paced treadmill walking (SPTW). Thereafter, participants will partake in 7 experimental conditions in a (semi-)randomized order:\n\n* 3 min standing\n* 3 min standing while answering semi-standardized questions\n* 3 min SPTW\n* 3 min SPTW while answering semi-standardized questions (SPTW-Q)\n* 3 min SPTW while verbally describing a VR environment (SPTW-VR1)\n* 6 min SPTW in a VR environment containing freezing of gait provoking elements (SPTW-VR2)', 'armGroupLabels': ['Healthy control group', "Parkinson's Disease group"]}, {'name': 'Speech assessments', 'type': 'OTHER', 'description': '* Acoustic analysis (including voice reports and formant analysis), video recording and motor speech profile (including analysis of diadochokinesis, voice, standard syllabic rate, intonation and second formant (F2)).\n* Spontaneous speech production will be assessed by answering semi-standardized questions based on the Aachen Aphasia Test and by describing a VR environment projected on a 180-degree cylindrical screen\n* The Speech Handicap Index (a 15-item self-reported questionnaire)', 'armGroupLabels': ['Healthy control group', "Parkinson's Disease group"]}, {'name': 'Audiology assessments', 'type': 'OTHER', 'description': '* Otoscopy\n* Tympanometry\n* Pure tone audiometry\n* Otoacoustic emissions\n* Video Head Impuls Test\n* Cervical Vestibular Evoked Myogenic Potentials\n* Ocular Vestibular Evoked Myogenic Potentials\n* Oculomotor function testing\n* Positional testing\n* Static visual acuity test\n* Dynamic visual acuity test\n* Dizziness Handicap Inventory (a 25-item self-assessment inventory)', 'armGroupLabels': ['Healthy control group', "Parkinson's Disease group"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Katie Bouche, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}, {'name': 'Leen Maes, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ghent'}, {'name': 'Anke Van Bladel, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ghent'}, {'name': 'Nina Lefeber, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Ghent', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}