Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT03479567
Status:
COMPLETED
Last Update Posted:
2023-12-18
First Post:
2018-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fine and Gross Motor Function and Relationship With Muscle Tone in Older Adults With and Without Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D009127', 'term': 'Muscle Rigidity'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'cross-sectional'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-12', 'studyFirstSubmitDate': '2018-03-13', 'studyFirstSubmitQcDate': '2018-03-20', 'lastUpdatePostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'walking speed', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'gait speed parameter'}, {'measure': 'step regularity', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'gait parameter representing regularity, autocorrelation (method Moe-Nilssen 2004), value between 0 and 1, with 1 representing perfect regularity'}, {'measure': 'mediolateral jerk', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'balance smoothness and coordination, lower jerk values correspond with better smoothness of balance'}, {'measure': 'anteroposterior jerk', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'balance smoothness and coordination, lower jerk values correspond with better smoothness of balance'}, {'measure': 'Fine motor function', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'score on the Purdue pegboard test, maximal amount of (pairs of) pegs placed in 30 seconds (max. 25)'}, {'measure': 'presence of paratonia', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'Paratonia Assessment Instrument, resistance against passive movements of the four limbs is evaluated (Hobbelen 2008)'}, {'measure': 'MyotonPRO measurement of muscle tone', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'MyotonPRO measurement'}], 'secondaryOutcomes': [{'measure': 'MyotonPRO measurement of elasticity', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'MyotonPRO measurement'}, {'measure': 'MyotonPRO measurement of mechanical stiffness', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'MyotonPRO measurement'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia', 'Gait', 'Balance', 'Muscle Tone', 'Fine Motor Function', 'Paratonia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was (1) to investigate changes in gait, balance, fine motor function, and muscle tone, and (2) to find out if there is a correlation between muscle tone/presence of paratonia and motor function (gross and fine) in mild and moderate dementia.Three groups of participants were included in the study: healthy elderly (n=60), participants with mild dementia (n=31) and participants with moderate dementia (n=31). Measurements of fine motor function, balance, gait, presence of paratonia and muscle tone measurements were performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>= 65 years\n* walk independently for at least 11 meters\n* HC: no cognitive deterioration, MiD: dementia, Global Deterioration Scale\\<5, MoD: dementia, Global Deterioration Scale 5 or 6\n\nExclusion Criteria:\n\n* recent (≤ 6 months) orthopedic surgery'}, 'identificationModule': {'nctId': 'NCT03479567', 'briefTitle': 'Fine and Gross Motor Function and Relationship With Muscle Tone in Older Adults With and Without Dementia', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'Fine and Gross Motor Function and Relationship With Muscle Tone in Older Adults With and Without Dementia', 'orgStudyIdInfo': {'id': 'EC/2014/1240'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'HC', 'description': 'Healthy controls, i.e. older adults without cognitive impairment', 'interventionNames': ['Other: Gait accelerometry', 'Other: balance accelerometry', 'Other: Fine motor skill test', 'Diagnostic Test: Paratonia Assessment Instrument (PAI)', 'Other: myotonometric measurement of muscle tone']}, {'type': 'OTHER', 'label': 'MiD', 'description': 'older adults with mild dementia', 'interventionNames': ['Other: Gait accelerometry', 'Other: balance accelerometry', 'Other: Fine motor skill test', 'Diagnostic Test: Paratonia Assessment Instrument (PAI)', 'Other: myotonometric measurement of muscle tone']}, {'type': 'OTHER', 'label': 'MoD', 'description': 'older adults with moderate dementia', 'interventionNames': ['Other: Gait accelerometry', 'Other: balance accelerometry', 'Other: Fine motor skill test', 'Other: myotonometric measurement of muscle tone']}], 'interventions': [{'name': 'Gait accelerometry', 'type': 'OTHER', 'description': 'accelerometric assessment of gait (Dynaport Hybrid): 7m walk in 3 conditions (normal pace, fast, double task)', 'armGroupLabels': ['HC', 'MiD', 'MoD']}, {'name': 'balance accelerometry', 'type': 'OTHER', 'description': 'accelerometric assessment of balance (Dynaport Hybrid) during 10 seconds trial in 3 conditions (side-by-side, semitandem, tandem)', 'armGroupLabels': ['HC', 'MiD', 'MoD']}, {'name': 'Fine motor skill test', 'type': 'OTHER', 'description': 'assessment of fine motor skills with Purdue Pegboard, with dominant hand, non-dominant hand and bimanual', 'armGroupLabels': ['HC', 'MiD', 'MoD']}, {'name': 'Paratonia Assessment Instrument (PAI)', 'type': 'DIAGNOSTIC_TEST', 'description': 'diagnosis of paratonia based on passive movement of the four limbs', 'armGroupLabels': ['HC', 'MiD']}, {'name': 'myotonometric measurement of muscle tone', 'type': 'OTHER', 'description': 'MyotonPRO measurement of muscle tone', 'armGroupLabels': ['HC', 'MiD', 'MoD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Vakgroep Revaki - Ghent University', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}