Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT05095805
Status:
COMPLETED
Last Update Posted:
2022-01-27
First Post:
2021-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Weight-bearing Exercise for Trans-tibial Amputees
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-26', 'studyFirstSubmitDate': '2021-10-14', 'studyFirstSubmitQcDate': '2021-10-14', 'lastUpdatePostDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in centre of pressure (COP) from baseline', 'timeFrame': 'Assessment at baseline and after two weeks', 'description': 'Calculation of COP (transversal plane, symmetry index, lateral, sagittal directions) from 4 pressure sensors built into the balance board'}, {'measure': 'Change in weight distribution in quiet standing', 'timeFrame': 'Assessment at baseline and after two weeks', 'description': 'COP assessment for 20s of quiet standing'}], 'secondaryOutcomes': [{'measure': 'Change in 10m walk test', 'timeFrame': 'Assessment at baseline and after two weeks'}, {'measure': 'Change in L-test', 'timeFrame': 'Assessment at baseline and after two weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['trans-tibial prosthesis', 'weight-bearing', 'balance', 'centre of pressure'], 'conditions': ['Amputation']}, 'descriptionModule': {'briefSummary': 'A simple weight-bearing exercise has been designed using off-the-shelves devices (Nintendo Wii Balance Board) and centre of pressure (COP) analysis software (Python) for trans-tibial amputees receiving their first prosthesis. A pilot randomised control study will be conducted to check the progress with weight-bearing training using COP-based objective measures. Additionally, gait and functional task performance will be assessed by means of clinical test. Participants will be divided into 2 groups: test group (performing additional weight-bearing exercises) and control group (receiving only conventional training for fitting of initial prosthesis).', 'detailedDescription': 'Each patient meeting the inclusion criteria will be randomised to either the test group or the control group. The patients will perform ten training sessions with the initial prosthesis, each session lasting for about 30 minutes, within the period of two weeks. They will be assessed at baseline and after the training program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* trans-tibial amputation,\n* fitted with first trans-tibial prosthesis,\n* independent mobility for 50m with or without assistive aid,\n* Functional Independence Measure (FIM) Stairs locomotion scale ≥ 5,\n* ability to follow the instructions, Mini Mental State Examination (MMSE) \\> 25,\n* no severe visual problems, ble to see computer screen,\n* willing to participate.\n\nExclusion Criteria:\n\n* bilateral lower limb amputation or any other level of unilateral lower limb amputation,\n* not candidates for prosthetic fitting.'}, 'identificationModule': {'nctId': 'NCT05095805', 'acronym': 'Prototest', 'briefTitle': 'Weight-bearing Exercise for Trans-tibial Amputees', 'organization': {'class': 'OTHER', 'fullName': 'University Rehabilitation Institute, Republic of Slovenia'}, 'officialTitle': 'Weight-bearing Training Exercise May Improve Loading of Trans-tibial Prosthesis and Functional Gait', 'orgStudyIdInfo': {'id': 'URIS202102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test group', 'description': 'additional weight-bearing exercise', 'interventionNames': ['Behavioral: additional weight-bearing exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'standard weight-bearing exercise', 'interventionNames': ['Behavioral: standard weight-bearing exercise']}], 'interventions': [{'name': 'additional weight-bearing exercise', 'type': 'BEHAVIORAL', 'description': 'Nintendo Wii Balance Board, real-time visual feedback, weight-bearing assessment by center of pressure', 'armGroupLabels': ['Test group']}, {'name': 'standard weight-bearing exercise', 'type': 'BEHAVIORAL', 'description': 'conventional training for fitting of initial prosthesis', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'University Rehabilitation Institute, Republic of Slovenia', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Helena Burger, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Rehabilitation Institute, Republic of Slovenia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Rehabilitation Institute, Republic of Slovenia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Slovenian Research Agency', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}