Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-18 @ 5:19 PM
Study NCT ID:
NCT01987557
Status:
COMPLETED
Last Update Posted:
2015-06-17
First Post:
2013-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Amplitude and Rate of Intrinsic Feedback During Treadmill Training for Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lass3260@mylaurier.ca', 'phone': '9056992087', 'title': 'Matthew Lasswell', 'organization': 'WilfridLU'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treadmill Intervention 1: Rate Group', 'description': 'Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.\n\nrate group: walking with a high cadence (steps per minute)', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Magnitude Treadmill Group', 'description': 'In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs\n\nmagnitude treadmill group', 'otherNumAtRisk': 16, 'otherNumAffected': 2, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Regular Treadmill Walking', 'description': 'participants will walk at a comfortable self-selected pace on a treadmill\n\nregular treadmill walking', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Muscle Strain', 'notes': 'Mild Hamstring strain.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'back muscle tightness', 'notes': 'minor back muscle discomfort leading the participant withdraw from the study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Motor Section of the Unified Parkinson's Disease Rating Scale (UPDRS-III)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treadmill Intervention 1: Rate Group', 'description': 'Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.\n\nrate group: walking with a high cadence (steps per minute)'}, {'id': 'OG001', 'title': 'Magnitude Treadmill Group', 'description': 'In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs\n\nmagnitude treadmill group'}, {'id': 'OG002', 'title': 'Regular Treadmill Walking', 'description': 'participants will walk at a comfortable self-selected pace on a treadmill\n\nregular treadmill walking'}], 'classes': [{'title': 'PRE', 'categories': [{'measurements': [{'value': '23.35', 'spread': '8.13', 'groupId': 'OG000'}, {'value': '22.96', 'spread': '6.93', 'groupId': 'OG001'}, {'value': '22.46', 'spread': '8.64', 'groupId': 'OG002'}]}]}, {'title': 'POST', 'categories': [{'measurements': [{'value': '18.81', 'spread': '7.17', 'groupId': 'OG000'}, {'value': '20.69', 'spread': '8.39', 'groupId': 'OG001'}, {'value': '20.92', 'spread': '6.14', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre assessments are conducted in the week prior to the treadmill program. Post are conducted during the week immediately following the program. Changes after the 6 week treadmill program are being examined', 'description': 'A measure of the motor symptom severity within Parkinsons. UPDRS III is a qualitative assessment performed by a trained clinician. Specifically, a change in UPDRS III from pre to post is the main outcome measure.\n\nThe UPDRS-III score is a summation of 27 tasks that are scored from 0-4. 0 meaning no impairment, and 4 representing extreme impairment, inability to complete task. Possible scores on the UPDRS-III range from 0 (no impairment) to 108 (extreme impairment).', 'unitOfMeasure': 'units on a scale (0-4)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Spatiotemporal Aspects of Gait', 'timeFrame': 'pre test occurs within the week prior to the start of the treadmill training program. Post testing will occur during the week immediately following the 6 week treadmill training program.', 'description': 'Participants will walk on a pressure sensitive GAITRite carpet (Sparta, NJ), at both comfortable and fast paced walking speeds. Changes in gait characteristics from pre to post are what is being examined.\n\nQuantitative measures of gait such as step time, step length, walking velocity, and others will be used in the analysis.\n\nSpotters are always present to ensure safety during this assessment.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Static Posturography (Balance/Postural Control)', 'timeFrame': 'pre test occurs within the week prior to the start of the treadmill training program. Post testing will occur during the week immediately following the 6 week treadmill training program.', 'description': 'A Balance SD system from BIODEX (Shirley, NY) will be used to assess postural control. Changes from pre to post are what is being examined.', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treadmill Intervention 1: Rate Group', 'description': 'Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.\n\nrate group: walking with a high cadence (steps per minute)'}, {'id': 'FG001', 'title': 'Magnitude Treadmill Group', 'description': 'In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs\n\nmagnitude treadmill group'}, {'id': 'FG002', 'title': 'Regular Treadmill Walking', 'description': 'participants will walk at a comfortable self-selected pace on a treadmill\n\nregular treadmill walking'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Treadmill Intervention 1: Rate Group', 'description': 'Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.\n\nrate group: walking with a high cadence (steps per minute)'}, {'id': 'BG001', 'title': 'Magnitude Treadmill Group', 'description': 'In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs\n\nmagnitude treadmill group'}, {'id': 'BG002', 'title': 'Regular Treadmill Walking', 'description': 'participants will walk at a comfortable self-selected pace on a treadmill\n\nregular treadmill walking'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.77', 'spread': '7.01', 'groupId': 'BG000'}, {'value': '70.46', 'spread': '9.52', 'groupId': 'BG001'}, {'value': '66.31', 'spread': '9.07', 'groupId': 'BG002'}, {'value': '66.85', 'spread': '8.83', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Unified Parkinsons Disease Rating Scale-Motor Subsection (UPDRS III)', 'classes': [{'categories': [{'measurements': [{'value': '23.35', 'spread': '8.13', 'groupId': 'BG000'}, {'value': '22.96', 'spread': '6.93', 'groupId': 'BG001'}, {'value': '22.46', 'spread': '8.64', 'groupId': 'BG002'}, {'value': '22.92', 'spread': '7.73', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-12', 'studyFirstSubmitDate': '2013-10-09', 'resultsFirstSubmitDate': '2015-02-18', 'studyFirstSubmitQcDate': '2013-11-12', 'lastUpdatePostDateStruct': {'date': '2015-06-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-12', 'studyFirstPostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Motor Section of the Unified Parkinson's Disease Rating Scale (UPDRS-III)", 'timeFrame': 'Pre assessments are conducted in the week prior to the treadmill program. Post are conducted during the week immediately following the program. Changes after the 6 week treadmill program are being examined', 'description': 'A measure of the motor symptom severity within Parkinsons. UPDRS III is a qualitative assessment performed by a trained clinician. Specifically, a change in UPDRS III from pre to post is the main outcome measure.\n\nThe UPDRS-III score is a summation of 27 tasks that are scored from 0-4. 0 meaning no impairment, and 4 representing extreme impairment, inability to complete task. Possible scores on the UPDRS-III range from 0 (no impairment) to 108 (extreme impairment).'}], 'secondaryOutcomes': [{'measure': 'Spatiotemporal Aspects of Gait', 'timeFrame': 'pre test occurs within the week prior to the start of the treadmill training program. Post testing will occur during the week immediately following the 6 week treadmill training program.', 'description': 'Participants will walk on a pressure sensitive GAITRite carpet (Sparta, NJ), at both comfortable and fast paced walking speeds. Changes in gait characteristics from pre to post are what is being examined.\n\nQuantitative measures of gait such as step time, step length, walking velocity, and others will be used in the analysis.\n\nSpotters are always present to ensure safety during this assessment.'}, {'measure': 'Static Posturography (Balance/Postural Control)', 'timeFrame': 'pre test occurs within the week prior to the start of the treadmill training program. Post testing will occur during the week immediately following the 6 week treadmill training program.', 'description': 'A Balance SD system from BIODEX (Shirley, NY) will be used to assess postural control. Changes from pre to post are what is being examined.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['treadmill', "parkinson's", 'proprioception', 'cadence', 'step length', 'intrinsic feedback'], 'conditions': ["Parkinson's Disease", 'Treadmill']}, 'descriptionModule': {'briefSummary': "Treadmill training has been shown to be beneficial for reducing motor symptoms of Parkinson's disease (PD). The mechanisms for the therapeutic effects of treadmill training remain unknown. However, specific types of intrinsic feedback generated from muscle spindles (detect changes in length of muscle) and golgi tendon organs (detect muscle force) seem to be an important factor for achieving the reductions in motor scores. This study will compare a treadmill program that generates a high rate of intrinsic feedback to a treadmill program focused on generating a high magnitude of intrinsic feedback."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* diagnosis of Parkinson's disease\n* must be able to walk unassisted for 10 metres\n\nExclusion Criteria:\n\n* cardiovascular disease/history of stroke\n* Dementia\n* lower body injury that would be worsened by repetitive walking"}, 'identificationModule': {'nctId': 'NCT01987557', 'briefTitle': "Amplitude and Rate of Intrinsic Feedback During Treadmill Training for Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Wilfrid Laurier University'}, 'officialTitle': "The Therapeutic Contributions of Somatosensory Feedback During Exercise in Parkinson's Disease; A Randomized, Controlled Trial.", 'orgStudyIdInfo': {'id': 'MDRC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treadmill Intervention 1: Rate Group', 'description': 'Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.', 'interventionNames': ['Behavioral: rate group']}, {'type': 'EXPERIMENTAL', 'label': 'Magnitude treadmill group', 'description': 'In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs', 'interventionNames': ['Behavioral: magnitude treadmill group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'regular treadmill walking', 'description': 'participants will walk at a comfortable self-selected pace on a treadmill', 'interventionNames': ['Behavioral: regular treadmill walking']}], 'interventions': [{'name': 'rate group', 'type': 'BEHAVIORAL', 'description': 'walking with a high cadence (steps per minute)', 'armGroupLabels': ['Treadmill Intervention 1: Rate Group']}, {'name': 'magnitude treadmill group', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Magnitude treadmill group']}, {'name': 'regular treadmill walking', 'type': 'BEHAVIORAL', 'armGroupLabels': ['regular treadmill walking']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wilfrid Laurier University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mr. Matthew Lasswell', 'investigatorFullName': 'Matthew Lasswell', 'investigatorAffiliation': 'Wilfrid Laurier University'}}}}