Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-26 @ 1:49 PM
Study NCT ID:
NCT06457659
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Early Prosthetic Fitting in Patients With Below-knee Amputation
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': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-10', 'studyFirstSubmitDate': '2024-06-10', 'studyFirstSubmitQcDate': '2024-06-10', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'World Health Organization Quality of life (WHO QOL)', 'timeFrame': '12 Months', 'description': "Questionnaire was used to measure the impact in both groups on quality of life. The WHOQOL is a quality-of-life assessment developed by the WHOQOL Group with fifteen international field centers, simultaneously, in an attempt to develop a quality-of-life assessment that would be applicable cross-culturally. The patient's physical, psychological, social, and environmental state of health is assessed separately in WHO\\_QOL known as the 4 domains of the questionnaire. 0 points represent the worst possible state of health, while 100 points represent the best possible state of health about the respective domain."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Amputation Stump']}, 'descriptionModule': {'briefSummary': 'A randomized control trial of 50 patients to identify the effect of early prosthetic fitting and physical rehabilitation. Previous studies show a significant impact of early induction of prosthetic rehabilitation of amputation. Delayed rehabilitation may cause severe physical complications like joint contracture, and muscle strength loss.', 'detailedDescription': 'Along with physical complications delays in rehabilitation may also significantly affect psychological, economic, and quality of daily life. Pakistan is a low-income developed country and the major cause of amputation here is traumatic amputation, which affects mostly younger age people. After missing a precious body part if the amputee comes along with such kind of physical and Psychological complications, his/her whole daily life will be affected. There is a keen need for the implementation of global rules for physical rehabilitation of amputees and disabled including the duration of induction of prosthetics as well as overall physical rehabilitation after surgical and traumatic removal of limbs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female below-knee amputees due to trauma and diabetes were included\n\nExclusion Criteria:\n\n* patients with comorbidities and old users of prostheses were excluded'}, 'identificationModule': {'nctId': 'NCT06457659', 'briefTitle': 'Effect of Early Prosthetic Fitting in Patients With Below-knee Amputation', 'organization': {'class': 'OTHER', 'fullName': 'Superior University'}, 'officialTitle': 'Effect of Early Prosthetic Fitting in Patients With Below Knee Amputation', 'orgStudyIdInfo': {'id': 'MSRSW/Batch-Fall22/728'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early Rehab Group', 'interventionNames': ['Behavioral: Early Rehab Group']}, {'type': 'OTHER', 'label': 'Delayed Rehab Group', 'interventionNames': ['Other: Delayed Rehab Group']}], 'interventions': [{'name': 'Early Rehab Group', 'type': 'BEHAVIORAL', 'description': 'The first group of 25 Patients was fitted with Prosthesis with in 6months of duration after amputation. The basic theme was to check the physical psychological and QOL in early prostheic-fitted patients through WHO\\_QOL.', 'armGroupLabels': ['Early Rehab Group']}, {'name': 'Delayed Rehab Group', 'type': 'OTHER', 'description': 'The 2nd group of 25 patients was fitted with Prosthesis after 6 months after amputation. No physical rehab was done during this period including physiotherapy and prosthetic treatment. The main aim was to check the significant impact of delayed rehabilitation.', 'armGroupLabels': ['Delayed Rehab Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dera Ismail Khan', 'state': 'Khyber Pakhtunkhwa', 'country': 'Pakistan', 'facility': 'Mobility Rehab care, Islamabad Medical Center', 'geoPoint': {'lat': 31.83129, 'lon': 70.9017}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Superior University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammad Naveed Babur', 'investigatorAffiliation': 'Superior University'}}}}