Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-01-02 @ 1:34 PM
Study NCT ID:
NCT06896032
Status:
RECRUITING
Last Update Posted:
2025-04-16
First Post:
2025-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retro-walking Versus Forward-walking Training Using Underwater Treadmill in Patients With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-03', 'releaseDate': '2025-11-16'}, {'releaseDate': '2025-12-04', 'unreleaseDate': '2025-12-04'}], 'estimatedResultsFirstSubmitDate': '2025-11-16'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000088543', 'term': 'Aquatic Therapy'}], 'ancestors': [{'id': 'D006875', 'term': 'Hydrotherapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Opaque sealed envelope'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Retro walking and forward walking training exercise'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-07-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-13', 'studyFirstSubmitDate': '2025-02-22', 'studyFirstSubmitQcDate': '2025-03-19', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'up to three monthes', 'description': 'Pain intensity will be measured by visual analog scale (VAS. ). It is line with worst pain at one end and no pain at the other end'}, {'measure': 'knee disability', 'timeFrame': 'up to three months', 'description': 'knee disablity will be measured by The Western Ontario and McMaster Universities osteoarthritis index. The WOMAC is a self-administered instrument containing 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items).Scores range from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status.'}], 'secondaryOutcomes': [{'measure': 'knee range of motion', 'timeFrame': 'up to three months', 'description': 'knee joint rang of motion will be measured by goniometer'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee Osteoarthritis'], 'conditions': ['Knee Osteoarthritis (Knee OA)', 'Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study Will investigate and compare the effects of retro-walking and forward-walking underwater treadmill training on pain, function and ROM in subjects with chronic knee OA', 'detailedDescription': 'In the current study, Sixty subjects from both genders, the dominant side only will be involved. They will be divided in to three equal groups: group A (experimental1), group B (experimental 2), group C (control), they will be signed a consent form to share in this study which aimed to investigate the effects of retro-walking and forward-walking underwater treadmill training on pain, function and ROM in subjects with chronic knee OA'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 60 patients with chronic knee OA.\n2. Age ranges from 40-60 years old of both genders.\n3. body mass index (BMI) 25- 35kg/m2.\n4. The degree of osteoarthritis was mild or moderate and have a Kellgren- Lawrence radiographic grade of of1-3.\n5. unilateral knee osteoarthritis involvement.\n\nExclusion Criteria:\n\n1. hydrophobia.\n2. pregnancy.\n3. infection.\n4. psychiatric disorder.\n5. haemorrhagic diathesis.\n6. cardiac pacemaker.\n7. all Subjects with deformity of hip, knee \\& ankle.\n8. any CNS or PNS involvement.\n9. recent steroidal or intraarticular injections (3 months).\n10. systemic inflammatory disease and bone malignancy.'}, 'identificationModule': {'nctId': 'NCT06896032', 'briefTitle': 'Retro-walking Versus Forward-walking Training Using Underwater Treadmill in Patients With Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Retro-walking Versus Forward-walking Training Using Underwater Treadmill on Pain and Function in Patients With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005428'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group A (experimental1)', 'description': 'forward walking group', 'interventionNames': ['Other: physical therapy intervention']}, {'type': 'EXPERIMENTAL', 'label': 'group B (experimental 2)', 'description': 'retro walking group', 'interventionNames': ['Other: physical therapy intervention']}, {'type': 'OTHER', 'label': 'group c', 'description': 'control group', 'interventionNames': ['Other: physical therapy intervention']}], 'interventions': [{'name': 'physical therapy intervention', 'type': 'OTHER', 'otherNames': ['hydro therapy', 'aquatic therapy'], 'description': 'retro-walking and forward-walking underwater treadmill training', 'armGroupLabels': ['group A (experimental1)', 'group B (experimental 2)', 'group c']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02', 'city': 'Cairo', 'state': 'Cairo Governorate', 'status': 'ENROLLING_BY_INVITATION', 'country': 'Egypt', 'facility': 'cairo U', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '02', 'city': 'Cairo', 'state': 'Cairo Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'role': 'CONTACT', 'email': 'eslamsawilm@gmail.com', 'phone': '01023770486'}, {'name': 'Eslam Sawilm', 'role': 'CONTACT'}], 'facility': 'cairo U', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'nourhan atwa said, bacalora', 'role': 'CONTACT', 'email': 'nourhan.atwa@icloud.com', 'phone': '+201005074315', 'phoneExt': '+201023770486'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nourhan Atwa Said', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'physical therapist', 'investigatorFullName': 'Nourhan Atwa Said', 'investigatorAffiliation': 'Cairo University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-11-16', 'type': 'RELEASE'}, {'date': '2025-12-03', 'type': 'RESET'}, {'date': '2025-12-04', 'type': 'RELEASE'}, {'date': '2025-12-04', 'type': 'UNRELEASE'}], 'unpostedResponsibleParty': 'Nourhan Atwa Said, physical therapist, Cairo University'}}}}