Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-29 @ 10:33 PM
Study NCT ID:
NCT04904003
Status:
COMPLETED
Last Update Posted:
2022-10-12
First Post:
2021-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prosthetic Use, Mobility and Daily Functioning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-07-03', 'releaseDate': '2025-06-17'}], 'estimatedResultsFirstSubmitDate': '2025-06-17'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'One explorative group, one intervention group and one control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-10', 'studyFirstSubmitDate': '2021-05-05', 'studyFirstSubmitQcDate': '2021-05-21', 'lastUpdatePostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Trinity Amputation and Prosthesis Experience Scale-Revised (TAPES-R) - psychosocial adjustment', 'timeFrame': '4-8 weeks', 'description': 'The questionnaire examines psychosocial processes involved in adapting to the prosthesis as well as specific needs when using prosthesis.\n\nPsychosocial adjustment - general subscale, provide a score range from 1.0-4.0. High scores indicative of positive adjustment.\n\nPsychosocial adjustment - social subscale, provide a score range from 1.0-4.0. High scores indicative of positive adjustment.\n\nPsychosocial adjustment - adjustment to limitation subscale, provide a score range from 1.0-4.0. High scores indicative of positive adjustment.'}, {'measure': 'Trinity Amputation and Prosthesis Experience Scale-Revised (TAPES-R) - activity restriction scale', 'timeFrame': '4-8 weeks', 'description': 'The questionnaire examines psychosocial processes involved in adapting to the prosthesis as well as specific needs when using prosthesis.\n\nActivity restriction scale, provide a score range from 0.0-2.0. High scores is indicative of activity restriction.'}, {'measure': 'Trinity Amputation and Prosthesis Experience Scale-Revised (TAPES-R) - satisfaction with prosthesis', 'timeFrame': '4-8 weeks', 'description': 'The questionnaire examines psychosocial processes involved in adapting to the prosthesis as well as specific needs when using prosthesis.\n\nSatisfaction with prosthesis - aesthetic satisfaction subscale, provide a score range from 3-9. High scores is indicative of satisfaction with prosthesis.\n\nSatisfaction with prosthesis - functional satisfaction subscale, provide a score range from 5-15. High scores is indicative of satisfaction with prosthesis.'}, {'measure': 'Activities-Specific Balance Confidence scale (ABC)', 'timeFrame': '4-8 weeks', 'description': 'The questionnaire measures how confident LLA are in performing ADL without losing balance or becoming unsteady. ABC provide a score range from 0-64. High scores indicate better outcome.'}, {'measure': 'EuroQoL 5L - health-related quality of life (EQ-5D-5L)', 'timeFrame': '4-8 weeks', 'description': 'Standardized generic instrument used to measure health outcomes and health-related quality of life. Each question provide a score range from 1-5. High scores indicate worse outcome.'}, {'measure': 'Two-minute walk test (2WT)', 'timeFrame': '4-8 weeks', 'description': 'The test measures functional mobility and the distance covered in two minutes.'}, {'measure': 'The L-Test of Functional Mobility (L-test)', 'timeFrame': '4-8 weeks', 'description': 'The test measures functional mobility and is designed specifically for LLA. The LLA walks as fast as possible in a 3 x 7 meter L-shaped walkway that requires change of direction both ways.'}, {'measure': 'General Perceived Self-Efficacy Scale (GSE)', 'timeFrame': '4-8 weeks', 'description': 'Assesses self-efficacy when coping with challenging demands in life. GSE provide a score range from 10-40. High scores indicate better outcome.'}, {'measure': 'Grip strength', 'timeFrame': '4-8 weeks', 'description': 'Grip strength as measured by hand dynamometer'}, {'measure': 'Balance', 'timeFrame': '4-8 weeks', 'description': 'Postural balance measured as center of pressure excursion by insoles with pressure sensors and a gyroscope sensor.'}, {'measure': 'Activity level', 'timeFrame': '4-8 weeks', 'description': 'Number of steps measured by an accelerometer'}, {'measure': 'Gait characteristics - temporal parameters', 'timeFrame': '4-8 weeks', 'description': 'Gait characteristics measured in seconds by insoles with pressure sensors and gyroscope sensor'}, {'measure': 'Gait characteristics - spatial parameters', 'timeFrame': '4-8 weeks', 'description': 'Gait characteristics measured in meters by insoles with pressure sensors and gyroscope sensor'}, {'measure': 'Gait characteristics - ground reaction force Gait characteristics - ground reaction force', 'timeFrame': '4-8 weeks', 'description': 'Gait characteristics measured in Newton by insoles with pressure sensors and gyroscope sensor'}], 'primaryOutcomes': [{'measure': 'Prosthetic Limb Users Survey of Mobility (Plus-M) Short form - 12 items', 'timeFrame': '4-8 weeks', 'description': 'A questionnaire that measures different aspects of mobility in lower-limb amputees (LLA) using prosthesis. PLUS-M provide a score range from 17.5 to 76.6. High scores indicate better outcome.'}, {'measure': 'The Amputee Mobility Predictor (AMP).', 'timeFrame': '4-8 weeks', 'description': 'The test is designed to measure mobility and ability to move with prosthesis (AMPPro) and without prosthesis (AMPNoPro). AMPPro provide a score range from 0-47. AMPNoPro provide a score range from 0-43. High scores indicate better outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rehabilitation', 'Prosthetic mobility', 'Outcome measures'], 'conditions': ['Lower Leg Amputations']}, 'descriptionModule': {'briefSummary': 'The goal of the project is to explore which elements of rehabilitation that influence mobility in new and experienced unilateral lower-limb amputees.', 'detailedDescription': 'Both new and experienced unilateral lower limb amputees (LLA) describe difficulties when ambulating intentionally and independently from one place to another using prosthesis. In LLA, this decreased ability to mobilize affect daily functioning and may result in low activity-levels, impeded social participation and reduced health-related quality of life.\n\nBoth primary and secondary rehabilitation of LLA have implications for functional mobility. The consensus among health professionals is that LLA should train to improve their ability to ambulate. However, knowledge from research regarding which elements that constitute effective training and how systematic exercise affects body structures, functions, activity and participation in lower limb amputees, is limited.\n\nThere also is a lack of knowledge of how prosthetic users endure and process the challenges regarding mobility, how they adapt to the use of their prosthesis, how safe they are ambulating using the prosthesis, and how pain and psychosocial issues affect their perceived health and mobility.\n\nThe aim of this Ph.D.-project is to explore how a period of semi-standardized individualized rehabilitation originating from an evidence-based approach, affect the functional mobility of both new and experienced LLA, and how LLA process the loss of a limb and challenges during ambulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria for experienced users of prosthesis - intervention group:\n\n* Unilaterally amputated (above the ankle joint / under the hip joint)\n* Minimum 12 months since amputation\n* Have a well-adapted prosthesis before baseline measurements\n* Not attended an organized, regular training program for the last 6 months\n* Uses the prosthesis on a daily basis\n* Participation approved by physician\n\nInclusion Criteria for experienced users of prosthesis - control group:\n\n* Unilaterally amputated (above the ankle joint / under the hip joint)\n* Minimum 12 months since amputation\n* Have a well-adapted prosthesis before baseline measurements\n* Daily use of the prosthesis\n* Not attended an organized, regular training program in the last 6 months\n* No participation in regular and systematic training between pre- and post-testing\n\nInclusion Criteria for new users of prosthesis:\n\n* Unilaterally amputated (above the ankle joint / under the hip joint)\n* No prior record of use of prosthesis\n* Participation approved by physician\n\nExclusion Criteria:\n\n* Bilaterally amputated over ankle joint\n* Lack of understanding of Norwegian language (oral, written)\n* Neurological disorders affecting gait function\n* Skin lesion or abrasion on the stump or remaining extremity affecting mobility and function\n* Other issues that complicate participation in a rehabilitation intervention'}, 'identificationModule': {'nctId': 'NCT04904003', 'acronym': 'ProMob', 'briefTitle': 'Prosthetic Use, Mobility and Daily Functioning', 'organization': {'class': 'OTHER', 'fullName': 'Oslo Metropolitan University'}, 'officialTitle': 'Prosthetic Use, Mobility and Daily Functioning', 'orgStudyIdInfo': {'id': '2018/2577'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experienced LLA - intervention', 'description': 'Experienced lower-limb amputees that complete a 4-week semi-structured individualized rehabilitation regime with extensive testing before and after the intervention.', 'interventionNames': ['Other: Rehabilitation Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Experienced LLA - controls', 'description': 'Experienced lower-limb amputees that will be tested with a 4-week interval. No intervention. This group will be matched to the group of experienced lower-limb amputees.', 'interventionNames': ['Other: Rehabilitation Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'New LLA learning to use prosthesis', 'description': 'New lower-limb amputees that complete a 8-11 weeks semi-structured individualized rehabilitation regime with extensive testing before and after the intervention.', 'interventionNames': ['Other: Rehabilitation Intervention']}], 'interventions': [{'name': 'Rehabilitation Intervention', 'type': 'OTHER', 'description': 'Strength, flexibility, endurance, balance, mobility, (self-efficacy)', 'armGroupLabels': ['Experienced LLA - controls', 'Experienced LLA - intervention', 'New LLA learning to use prosthesis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1765', 'city': 'Halden', 'state': 'Akershus', 'country': 'Norway', 'facility': 'Unicare Bakke'}, {'zip': '0130', 'city': 'Oslo', 'country': 'Norway', 'facility': 'OsloMet', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Terje Gjøvaag, PhD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Associate professor and Head of research group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not a plan to make IPD available. The GDPR-regulations make sharing of research data both time-consuming and difficult.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo Metropolitan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sophies Minde Ortopedi', 'class': 'INDUSTRY'}, {'name': 'UniCare Bakke AS', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-06-17', 'type': 'RELEASE'}, {'date': '2025-07-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Oslo Metropolitan University'}}}}