Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT06563258
Status:
RECRUITING
Last Update Posted:
2024-08-20
First Post:
2024-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Biodex Balance Training Versus Whole Body Vibration Training in Patients With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Prospective parallel group single-blind randomized control trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-18', 'studyFirstSubmitDate': '2024-08-18', 'studyFirstSubmitQcDate': '2024-08-18', 'lastUpdatePostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'one month', 'description': 'Pain intensity will be measured by visual analogue scale (VAS).'}, {'measure': 'static balance', 'timeFrame': 'one month', 'description': 'static balance will be measured by Postural stability test by Biodex balance SD.'}, {'measure': 'Dynamic balance', 'timeFrame': 'one month', 'description': 'Dynamic balance will be measured by Limit of stability Test by biodex balance SD.'}, {'measure': '.Functional abilities', 'timeFrame': 'one month', 'description': 'Functional abilities will be measured by Arabic- language version of knee injury and osteoarthritis outcome score physical function short form (KOOS-PS).'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to answer the research question:\n\nAre there differences between the effect of Biodex balance training and Whole-body vibration training on Knee osteoarthritis?', 'detailedDescription': 'The purpose of this study is to compare the effects of biodex training balance versus whole body vibration training on Knee osteoarthritis on:\n\n* Pain intensity\n* static balance\n* dynamic balance\n* Functional ability level'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Subjects age between (40-60) years old.\n2. Radiologic findings had to be compatible with knee OA grade 2 in a simple X ray.\n3. Tenderness on medial tibial plateau\n4. Intensity of pain: visual analogue scale equal to 5 or greater\n5. Failure of two or more types of previous conservative treatment (medication, anti-inflammatory drugs, physical therapy, stretching, acupuncture, orthotics and others) in the last three months\n\nExclusion Criteria:\n\n1. Neurological and vestibular system disorder, systematic inflammatory disease, steroid injections in the last six months\n2. Subjects with diabetes mellitus.\n3. acute symptomatic arthritis\n4. other conditions (such as osteomyelitis, tuberculosis, and tumor) that affect their walking function; had a contraindication to exercise; and exhibited cognitive impairment'}, 'identificationModule': {'nctId': 'NCT06563258', 'briefTitle': 'Efficacy of Biodex Balance Training Versus Whole Body Vibration Training in Patients With Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Efficacy of Biodex Balance Training Versus Whole Body Vibration Training in Patients With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005293'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Whole Body Vibration Training in Patients With Knee Osteoarthritis', 'description': 'Group A Will receive WBV Training with frequency of 35 Hz, peak-to-peak amplitude of 4- to 6-mm Vertical sinusoidal vibration, and the total exposure time of 30 minutes (vibration 60 seconds, interval rest 60 seconds) in addition to traditional exercises,3 sessions per week for four weeks.', 'interventionNames': ['Device: A vibration device', 'Other: traditional exercises']}, {'type': 'EXPERIMENTAL', 'label': 'Biodex Balance Training in Patients With Knee Osteoarthritis', 'description': 'Group B will receive Biobex training, Total time of training was 10 minutes each set is 3 minutes with 20-second rest intervals in addition to traditional exercises,3 sessions per week for four weeks.\n\n\\-', 'interventionNames': ['Device: Biodex Balance Training']}, {'type': 'EXPERIMENTAL', 'label': 'traditional exercises in Patients With Knee Osteoarthritis', 'description': 'Group C Patients will receive only traditional exercises, 3 sessions per week for four weeks. a good general guideline is 2-3 sets of 10-15 repetitions for each exercise.', 'interventionNames': ['Other: traditional exercises']}], 'interventions': [{'name': 'Biodex Balance Training', 'type': 'DEVICE', 'description': 'Sixty Subjects of both genders aged 40-60 years old with grade 2 knee osteoarthritis years will diagnosed by orthopedists they will assigned randomly into three groups:\n\n* Group A Will receive WBV Training with frequency of 35 Hz, peak-to-peak amplitude of 4- to 6-mm Vertical sinusoidal vibration, and the total exposure time of 30 minutes (vibration 60 seconds, interval rest 60 seconds) in addition to traditional exercises,3 sessions per week for four weeks. , A vibration device (My7™ model Personal Plate, Power Plate, Northbrook, IL, USA) will used in all WBVT sessions.\n* Group B will receive Biobex training and traditional exercises Total time of training was 10 minutes each set is 3 minutes with 20-second rest intervals\n* Group C Patients will receive only traditional exercises, 3 sessions per week for four weeks. a good general guideline is 2-3 sets of 10-15 repetitions for each exercise.', 'armGroupLabels': ['Biodex Balance Training in Patients With Knee Osteoarthritis']}, {'name': 'A vibration device', 'type': 'DEVICE', 'description': 'WBV Training with frequency of 35 Hz, peak-to-peak amplitude of 4- to 6-mm Vertical sinusoidal vibration, and the total exposure time of 30 minutes (vibration 60 seconds, interval rest 60 seconds) in addition to traditional exercises,3 sessions per week for four weeks. , A vibration device (My7™ model Personal Plate, Power Plate, Northbrook, IL, USA) will used in all WBVT sessions.', 'armGroupLabels': ['Whole Body Vibration Training in Patients With Knee Osteoarthritis']}, {'name': 'traditional exercises', 'type': 'OTHER', 'description': '1. Stretch exercises (flexibility exercise) Rectus femoris, Iliotibial band, Hamstring and self-stretch for calf muscle (3sets, each stretch 30 sec hold, between each set 5sec rests).\n2. Strengthen exercises(resistance exercise)\n\n 1. Isometric Exercises for quadriceps (10 rep,3sets)\n 2. Hip abductors strengthening 45 degree (10 rep,3sets)\n 3. Hip extensor strengthening 15 degree (10 rep,3sets)\n 4. Straight leg raising 45-70 degree (10 rep,3sets)\n 5. Short arc knee extension (10 rep,3sets)', 'armGroupLabels': ['Whole Body Vibration Training in Patients With Knee Osteoarthritis', 'traditional exercises in Patients With Knee Osteoarthritis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Mti University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'WALAA W.M MOHAMED, master', 'role': 'CONTACT', 'email': 'dr-walaamohamed@hotmail.com', 'phone': '01024098806'}, {'name': 'WALAA MOHAMED, master', 'role': 'CONTACT', 'email': 'dr-walaamohamed@hotmail.com', 'phone': '01024098806'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'walaa', 'investigatorAffiliation': 'Cairo University'}}}}