Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-30 @ 7:39 AM
Study NCT ID:
NCT07067203
Status:
COMPLETED
Last Update Posted:
2025-07-16
First Post:
2025-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship of Quadriceps and Hamstring Strength on Timed up and go Scores in Transtibial Amputees
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-05', 'studyFirstSubmitDate': '2025-07-05', 'studyFirstSubmitQcDate': '2025-07-05', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between the effect of quadriceps and hamstring strength by using Lafayette hand held dynamometer on the average of timed up and go scores in adults with tarns - tibial amputation', 'timeFrame': '6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transtibial amputation', 'transtibial amputee', 'Timed up and go', 'Hamstring muscle strength', 'quadriceps muscle strength', 'Transtibial amputation - unilateral'], 'conditions': ['Amputation', 'Transtibial Amputation - Unilateral', 'Quadriceps Muscle Strength', 'Hamstring Muscle Strength', 'Timed Up and Go']}, 'descriptionModule': {'briefSummary': 'To investigate the correlation between the effect of quadriceps and hamstring strength on timed up and go scores in adults with tarns - tibial amputation', 'detailedDescription': 'Lower limb amputation (LLA) has a significant socioeconomic and psychological impact on both individuals and communities. Despite these effects, major lower limb amputations remain relatively common worldwide. The causes of amputation vary by region, with the majority being non-traumatic in nature-most commonly linked to conditions such as diabetes mellitus, peripheral vascular disease, and cancer.\n\nIndividuals with lower limb amputation often experience musculoskeletal limitations, including reduced strength in the residual limb, limited range of motion (particularly in prosthetic joints), and challenges with postural control. As a result, they face a higher risk of falls compared to their able-bodied peers.\n\nThere has been limited research over the past two decades examining the use of the Timed Up and Go (TUG) test in adults with LLA. Since muscle strength plays a critical role in functional mobility, assessing the biomechanical and muscular conditions of individuals with amputation is essential for restoring daily function.\n\nUnilateral amputation causes biomechanical asymmetries, making it important to monitor strength development in both the residual and intact limbs during prosthetic rehabilitation. Strength assessments can support balance recovery, improve movement confidence, and enhance gait performance.\n\nStudy Aim This study aims to explore the relationship between quadriceps strength in the amputated limb and Timed Up and Go (TUG) scores in adults with unilateral lower limb amputation. It will also investigate the association between hamstring strength and TUG scores in the same population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All participants age 50 years or older, with the reason for amputation either peripheral vascular disease or diabetic complications (Nadollek \\& Brauer, 2002).\n2. Unilateral transtibial amputation only (Wood, 2022).\n3. K-level (2 to 4) (Gailey et al., 2002).\n4. Normal Body mass index ranged from 18.5 to 30.0 (Nuttall, 2015).\n\nExclusion Criteria:\n\n1. Residual limb revision in the past six months (Wood, 2022).\n2. Open wounds or sores on the residual limb limiting the ability to don/doff prosthesis (Wood, 2022).\n3. Uncontrolled comorbidities such as cardiovascular disease, active cancer treatment, and uncontrolled Diabetes Mellitus (Wood, 2022).'}, 'identificationModule': {'nctId': 'NCT07067203', 'briefTitle': 'The Relationship of Quadriceps and Hamstring Strength on Timed up and go Scores in Transtibial Amputees', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Correlation Between The Effect Of Quadriceps And Hamstring Strength On Timed Up And Go Scores In Adults With Tarns - Tibial Amputation', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004809'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adults with Unilateral Transtibial Amputation', 'description': 'Participants in this arm are adults aged 50 years or older with a unilateral transtibial amputation resulting from peripheral vascular disease or diabetic complications. All participants will have a K-level classification of 3 or 4 and a BMI within the normal range (18.5-29.9).\n\nEach participant will undergo two primary assessments:\n\n1. Muscle Strength Measurement\n2. Timed Up and Go (TUG) Test', 'interventionNames': ['Device: Lafayette hand held dynamometer', 'Diagnostic Test: Timed up and Go test']}], 'interventions': [{'name': 'Lafayette hand held dynamometer', 'type': 'DEVICE', 'description': 'Muscle Strength Measurement:\n\nThe strength of the quadriceps (knee extensors) and hamstrings (knee flexors) of the amputated limb will be measured using a handheld digital dynamometer (Nicholas MMT, Lafayette Instruments). Measurements will be taken with the prosthesis in place. Quadriceps strength will be assessed in a supine position with the knee at 30° flexion, while hamstring strength will be assessed in a prone position with the knee at 20° flexion. Each participant will perform three maximal effort trials after a practice attempt. The highest value will be scaled to body mass for analysis.', 'armGroupLabels': ['Adults with Unilateral Transtibial Amputation']}, {'name': 'Timed up and Go test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Timed Up and Go (TUG) Test:\n\nParticipants will complete a standardized 3-meter TUG assessment to evaluate functional mobility. The test will be broken down into five components: standing, walking, turning, returning, and sitting. After one practice run, two timed trials will be conducted, and the average of both will be used for analysis. All procedures will be conducted by trained physical therapists following a standardized protocol.', 'armGroupLabels': ['Adults with Unilateral Transtibial Amputation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'facility': 'Physical Therapy College Cairo University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yasmeen Essam Mohamed Abdelhafez', 'investigatorAffiliation': 'Cairo University'}}}}