Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-01-02 @ 11:53 AM
Study NCT ID:
NCT02031835
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2014-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Body Weight Supported Treadmill Training as Physical Therapy Treatment to Spinal Cord Injury Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-02', 'studyFirstSubmitDate': '2014-01-07', 'studyFirstSubmitQcDate': '2014-01-07', 'lastUpdatePostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WISCI II', 'timeFrame': 'At the time of Admittance to the rehabilitation department (at baseline) and after six weeks', 'description': 'Change of walking independence at six weeks'}], 'secondaryOutcomes': [{'measure': 'ASIA standard neurological classification for spinal cord injury patients working sheet', 'timeFrame': 'At the time of Admittance to the rehabilitation department (at baseline) and after six weeks', 'description': 'Change of neurological impairment status at six weeks'}, {'measure': 'Modified Ashworth scale', 'timeFrame': 'At the time of Admittance to the rehabilitation department (at baseline) and after six weeks', 'description': 'Change of spasticity of leg muscles at six weeks'}, {'measure': 'WHOQOL-BREF', 'timeFrame': 'At the time of Admittance to the rehabilitation department (at baseline) and after six weeks', 'description': "Change of patients' perspective of life quality at six weeks"}, {'measure': '10-item Modified Barthel Index', 'timeFrame': 'At the time of Admittance to the rehabilitation department (at baseline) and after six weeks', 'description': 'Change of function at six weeks'}, {'measure': 'DXA scan', 'timeFrame': 'At the time of Admittance to the rehabilitation department (at baseline) and after six weeks', 'description': 'Change of BMD of hip and spine at six weeks'}, {'measure': 'Full Body DXA scan', 'timeFrame': 'At the time of Admittance to the rehabilitation department (at baseline) and after six weeks', 'description': 'Change of body tissue consistency at six weeks'}, {'measure': 'Hematological analysis', 'timeFrame': 'At the time of Admittance to the rehabilitation department (at baseline) and after six weeks', 'description': "Change of blood's calcitonin, osteocalcin, 25 OH vitamin D, 1,25- (OH)2 vitamin D, ostase and parathyroid hormone concentrations at six weeks"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spinal Cord Injury/Damage']}, 'descriptionModule': {'briefSummary': "The purpose of this current prospective study is to assess the effects of body weight support treadmill training (BWSTT) in individuals with spinal cord injury (SCI). Training intervention aim at improving: quality of life, walking capability, spasticity, functions in every day life, bone mass density and related hematological factors. The examination consisted of (1) neurological classification by ASIA standard neurological classification of spinal cord injury working sheet, (2) spasticity evaluation of lower limbs by Modified Ashworth Scale, (3) walking independence evaluation by Walking Index for Spinal Cord Injury II (WISCI II), (4) patient's quality of life perspective by World Health Quality of Life- BREF (WHOQOL-BREF), (5) the functional status by 10-item Modified Barthel Index, (6) bone mass density (BMD) by Dual-energy X-ray absorptiometry (DXA) scan, (7) body tissue consistency by full body DXA scan, (8) skeletal system health associated blood factors (calcitonin, osteocalcin, 25 OH vitamin D, 1,25- (OH)2 vitamin D, ostase and parathyroid hormone) by hematological tests. The results will be collected and evaluated using statistical software (i.e. SPSS)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '88 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* SCI\n* ASIA classification B, C or D\n* clinical stable\n\nExclusion Criteria:\n\n* unstable cardiac conditions\n* epilepsy\n* autonomic dysreflexia\n* significant musculoskeletal problems in lower extremities other than SCI\n* Parkinson's disease"}, 'identificationModule': {'nctId': 'NCT02031835', 'briefTitle': 'Body Weight Supported Treadmill Training as Physical Therapy Treatment to Spinal Cord Injury Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Ioannina'}, 'officialTitle': 'Body Weight Supported Treadmill Training as Physical Therapy Treatment to Spinal Cord Injury Patients', 'orgStudyIdInfo': {'id': 'UIoannina612014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'BWSTT (3 days a week for maximum of 20 minutes session)', 'description': 'BWSTT (20 minutes of treadmill training (velocity (≥0.1km/h) and body weight support (≤40% of patients weight) according to patients capability and comfort', 'interventionNames': ['Procedure: BWSTT (3 days a week for maximum of 20 minutes session)']}], 'interventions': [{'name': 'BWSTT (3 days a week for maximum of 20 minutes session)', 'type': 'PROCEDURE', 'armGroupLabels': ['BWSTT (3 days a week for maximum of 20 minutes session)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ioannina', 'country': 'Greece', 'facility': 'University Hospital of Ioannina', 'geoPoint': {'lat': 39.66341, 'lon': 20.85187}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ioannina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Invastigator', 'investigatorFullName': 'Avraam Ploumis', 'investigatorAffiliation': 'University of Ioannina'}}}}