Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT04782167
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2021-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Proprioception and BRACE Training in Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001915', 'term': 'Braces'}], 'ancestors': [{'id': 'D009989', 'term': 'Orthotic Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-08', 'studyFirstSubmitDate': '2021-03-01', 'studyFirstSubmitQcDate': '2021-03-01', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Berg balance scale', 'timeFrame': '20 minutes', 'description': 'it is measure of dynamic and static balance'}, {'measure': 'Time up and go test', 'timeFrame': 'less than 3 minutes', 'description': 'it is also measure of static and dynamic balance'}, {'measure': 'clinical test of sensory interaction on balance', 'timeFrame': '20 minutes', 'description': 'test for balance'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['proprioception training, balance, BBS,'], 'conditions': ['Osteoarthritis Knees Both']}, 'descriptionModule': {'briefSummary': 'Knee osteoarthritis is common joint disorder in older adults. The prevalence of osteoarthritis is increasing in the elderly population and due to obesity.The aim of this study to compare improvement in balance between BRACE and proprioceptive training in knee osteoarthritis and to compare mobility level between proprioceptive and BRACE in knee osteoarthritis', 'detailedDescription': 'Knee osteoarthritis is common joint disorder in older adults. The prevalence of osteoarthritis is increasing in the elderly population and due to obesity. Balance disorder generally disturbed equilibrium and increase risk of fall. There is lack of proprioceptive sensation in patients with knee osteoarthritis. The aim of this study to compare improvement in balance between BRACE and proprioceptive training in knee osteoarthritis and to compare mobility level between proprioceptive and BRACE in knee osteoarthritis. Randomized control trial study of 8 week follows up. Sample size will be 22. The patients will be divided into 2 groups BRACE and proprioceptive training. The patients will get training section for 3 days per week for 8 weeks. The measurement will be taken at base line, after 8 weeks. Study duration will be 6 months. Individuals of age 50-70 year, Mini-mental state examination (MMSE) 20 or higher, Berg Balance Scale (BBS) 30-45 points, Experience of at least one fall during the previous 12 months, both Males and Females will be include. Patients will be excluded if they exhibited history of cardiovascular or musculoskeletal diseases, previously used medication for the central nervous system, occurrence of lower limbs lesions or fractures in last six months. Assessment tools will be MMSE, Berg balance scale, TUG, CTSIB, 6 minute walk test. Data will be analyzed through SPSS 20. Data will be check for its normality, within groups comparison paired sample T-test, between groups independent sample T-test will be used'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 50-70 years.\n* Both Males and Females\n* Knee osteoarthritis unilateral and bilateral (12).\n* American College of Rheumatology (ACR) criteria for diagnosing osteoarthritis of knee joint is presence of pain in knee joint plus any three of six factors listed below (13).\n* Age more than 50 y\n* Presence of crepitus on active motion\n* Less than 30 min of morning stiffness\n* Bony tenderness\n* Bony overgrowth\n* No palpable warmth of synovium\n* Mini-mental state examination (MMSE) 23 or higher (14).\n* Berg Balance Scale (BBS) 30-45 points (4)\n\nExclusion Criteria:\n\n* History of stroke during the previous 12 months\n* History of cardiovascular or musculoskeletal diseases,\n\n * Previously used medication for the central nervous system.\n* Presence of lower limb lesions or fractures in the last six months'}, 'identificationModule': {'nctId': 'NCT04782167', 'briefTitle': 'Proprioception and BRACE Training in Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Comparison Of Brace (Balance, Resistance, Aerobic, Cognitive Exercise) And Proprioceptive Training On Balance And Mobility In Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'Riphah IU Ali'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Proprioception training', 'description': 'Researcher give proprioception protocol to one group', 'interventionNames': ['Behavioral: Propirioceptive training']}, {'type': 'EXPERIMENTAL', 'label': 'Brace', 'description': 'Researcher give BRace training to one group', 'interventionNames': ['Behavioral: BRACE']}], 'interventions': [{'name': 'BRACE', 'type': 'BEHAVIORAL', 'description': 'Balance training,Static balance:\n\n1. Romberg with eye open \\& eye close \\[30 sec repeat 3 times\\]\n2. Tandem standing with eye open then with eye close. Right foot front first, then left foot front \\[10 Sec repeat 3 times\\]\n3. Single leg stance 5 repetition with sec.\n\nStatic/Dynamic/Anti-cipatory Postural Control:\n\n1. Sit to stand: 5 repetition\n2. Functional reach test: forward, sideways \\& cross reach, practice 1 min for each\n3. TUG test: with distance of 10 feet \\& time 10 sec. practice 2 min Cognitive exercises\n\n1\\) Count reverse from 50 Repeat with eyes open and close Reps of 30s for each 2) Push wall and reverse count from 20 3) Remember 5 words, Name 5 animals, Repeat 5 words', 'armGroupLabels': ['Brace']}, {'name': 'Propirioceptive training', 'type': 'BEHAVIORAL', 'description': '1st Phase - Steady phase (1st set: Eyes Open, 2nd set: Eyes Close) Preserve standup position Equally heels up and down Preserve standup on one leg by turns', 'armGroupLabels': ['Proprioception training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Faisalābad', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Independent University Hospital, faisalabad'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'khadija liaquat', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Lecturer', 'investigatorFullName': 'khadija liaquat', 'investigatorAffiliation': 'Riphah International University'}}}}