Ignite Creation Date:
2025-12-25 @ 1:37 AM
Ignite Modification Date:
2026-02-11 @ 7:45 PM
Study NCT ID:
NCT04169594
Status:
COMPLETED
Last Update Posted:
2021-10-22
First Post:
2019-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Statistical Parametric Mapping (SPM 1D) for Stroke and Trans-tibial Amputation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-20', 'studyFirstSubmitDate': '2019-11-10', 'studyFirstSubmitQcDate': '2019-11-17', 'lastUpdatePostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body movement assessed by a motion capture system', 'timeFrame': 'Assessed within 1 year after patient recruitment', 'description': 'Direction and magnitude of each body movement will be combined to provide graphical data on a motion capture system'}], 'secondaryOutcomes': [{'measure': 'Fugl Meyer Assessment', 'timeFrame': 'Assessed within 1 year after patient recruitment', 'description': 'Functional score for stroke patients. Minimum: 0, Maximum: 226, with higher score indicating better function'}, {'measure': 'Stroke Impact Scale', 'timeFrame': 'Assessed within 1 year after patient recruitment', 'description': 'Functional score for stroke patients. Minimum:1, Maximum: 5, with higher score indicating higher impairment'}, {'measure': 'Amputee Mobility Predictor with prosthesis', 'timeFrame': 'Assessed within 1 year after patient recruitment', 'description': 'Functional score for amputation patients. Minimum: 0, Maximum: 47, with higher score indicating better function.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Amputation']}, 'descriptionModule': {'briefSummary': 'Gait analysis is commonly performed in clinical practice. However, it is complex and requires an understanding of the activation of muscles in lower limbs, trunk, and upper limbs in a specific spatiotemporal pattern and the appropriate joint positions which support and advance the body weight in different phases of gait cycles.\n\nIn study, we plan to pilot the application of 3D gait analysis with statistical modelling in 2 common causes of gait deviation: unilateral hemiplegic stroke and unilateral lower limb amputation.', 'detailedDescription': 'This is a pilot study on the use of 3D gait analysis using motion capture in combination with Statistical Parametric Mapping in patients with unilateral hemiplegic stroke and unilateral lower limb amputation. Data collected will then be compared against a normative dataset.\n\nThe findings from this study will then be used to build a decision support tool in combination with clinical analysis which could focus clinical recommendations for gait training, physical therapy, exercise and orthotics prescription to reduce unnecessary joint forces in affected and unaffected segments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in outpatient clinics', 'eligibilityCriteria': 'Inclusion Criteria for stroke patients:\n\n* First ever chronic unilateral hemiparetic stroke subjects, with stroke diagnosed by a physician and confirmed via CT/MRI\n* \\>6 months post stroke\n* ambulant with at most contact guard/standby supervision with/without walking aid during the study\n* 10m Walk Test \\>/=0.2m/s and 6min Walking test walking distance of \\>/=50m without rest stop, with Functional Ambulation Category of \\>/=4 ((Holden et al, 1994)\n* AMT\\>6\n* able to understand study procedures and sign informed consent\n* able to attend a single 2.5h session of research data collection.\n\nInclusion Criteria for amputee patients:\n\n* First ever chronic unilateral transtibial amputee subjects\n* intact residual limb\n* \\> 6 months post amputation\n* ambulant with at most contact guard/standby supervision with/without walking aid during the study\n* 10m Walk Test \\>/=0.2m/s and 6min Walking test walking distance of \\>/=50m without rest stop\n* with Medicare K level of \\>1\n* AMT\\>6\n* able to understand study procedures and sign informed consent\n* able to attend a single 2.5h session of research data collection.\n\nExclusion Criteria:\n\n* Unstable recent cardiorespiratory conditions including uncontrolled hypertension/ hypotension, angina pectoris, myocardial infarction, active congestive cardiac failure, untreated cardiac arrhythmias (e.g. atrial fibrillation), untreated pulmonary embolism or deep vein thrombosis, presence of cardiac pacemaker.\n* Functional status: severe aphasia or neglect (inability to obey 1 steps command), communication disorder precluding understanding of instructions, cognitive impairment, dementia, untreated depression or psychiatric disorder.\n* End stage conditions such as medical instability or orthostatic insufficiency, organ, renal, liver, heart failure and life expectancy \\<6 months or on haemodialysis.\n* Pregnancy.\n* Local limb conditions which could be exacerbated by research interventions such as open wounds, ulcers, stump pain or stump wounds/ulcers, neuromas in amputees, active arthritis or joint or limb pain.\n* Skin conditions which could be worsened by application of adhesive skin markers such as uncontrolled eczema, psoriasis, fungal or bacterial infections etc.'}, 'identificationModule': {'nctId': 'NCT04169594', 'briefTitle': 'Statistical Parametric Mapping (SPM 1D) for Stroke and Trans-tibial Amputation', 'organization': {'class': 'OTHER', 'fullName': 'Tan Tock Seng Hospital'}, 'officialTitle': 'Guiding Best Practice Clinical Care With In-Silico Rehabilitation and Statistical Parametric Mapping (SPM 1D) for Unilateral Chronic Hemiparetic Stroke and Trans-tibial Amputation: An Exploratory Clinical Study', 'orgStudyIdInfo': {'id': 'DSRB_2019_99879'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stroke', 'description': 'Unilateral hemiplegic stroke patients', 'interventionNames': ['Diagnostic Test: 3D Gait Analysis with Statistical Parametric Mapping']}, {'label': 'Amputee', 'description': 'Unilateral transtibial amputee patients', 'interventionNames': ['Diagnostic Test: 3D Gait Analysis with Statistical Parametric Mapping']}], 'interventions': [{'name': '3D Gait Analysis with Statistical Parametric Mapping', 'type': 'DIAGNOSTIC_TEST', 'description': 'A 3D motion capture system will be used for gait analysis. Vector field statistics will be used to simplify the clinical interpretation of time varying movement patterns.', 'armGroupLabels': ['Amputee', 'Stroke']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'country': 'Singapore', 'facility': 'Tan Tock Seng Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Karen Chua', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tan Tock Seng Hospital'}, {'name': 'Cyril Donnelly', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rehabilitation Research Institute of Singapore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tan Tock Seng Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nanyang Technological University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}