Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-04 @ 3:32 AM
Study NCT ID:
NCT04019366
Status:
COMPLETED
Last Update Posted:
2019-07-15
First Post:
2019-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Balance Training Using Biodex Stability System in Knee Osteoarthritis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Patients were masked from the treatment procedure by Sealed envelope methods. Patients were randomly distributed into two groups.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment of patients into two groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-12', 'studyFirstSubmitDate': '2019-07-10', 'studyFirstSubmitQcDate': '2019-07-12', 'lastUpdatePostDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time up and Go test (TUG)', 'timeFrame': 'Baseline', 'description': 'Patients were asked to perform test at usual walking speed. Initial testing standardized verbal instructions given to the participant regarding procedure. For performing TUG participants were instructed to walk three meter and then, walk back to sit down. Note time on stopwatch. The average of tests trail was measured as the mean of TUG.'}, {'measure': 'Time up and Go test (TUG)', 'timeFrame': 'Post 4th Week', 'description': 'Patients were asked to perform test at usual walking speed. Initial testing standardized verbal instructions given to the participant regarding procedure. For performing TUG participants were instructed to walk three meter and then, walk back to sit down. Note time on stopwatch. The average of tests trail was measured as the mean of TUG.'}, {'measure': 'overall stability index (OSI)', 'timeFrame': 'Baseline', 'description': 'Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .94'}, {'measure': 'overall stability index (OSI)', 'timeFrame': 'Post 4th Week', 'description': 'Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .94'}, {'measure': 'Anterior-posterior stability index (APSI)', 'timeFrame': 'Baseline', 'description': 'Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .95'}, {'measure': 'Anterior-posterior stability index (APSI)', 'timeFrame': 'Post 4th Week', 'description': 'Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .95'}, {'measure': 'Medial-lateral stability index (MLSI)', 'timeFrame': 'Baseline', 'description': 'Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .93'}, {'measure': 'Medial-lateral stability index (MLSI)', 'timeFrame': 'Post 4th Week', 'description': 'Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .93'}], 'secondaryOutcomes': [{'measure': 'Numeric Pain Rating Scale (NPRS)', 'timeFrame': 'Baseline', 'description': 'Numeric Pain Rating Scale (NPRS) is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.'}, {'measure': 'Numeric Pain Rating Scale (NPRS)', 'timeFrame': 'post 4th week', 'description': 'Numeric Pain Rating Scale (NPRS) is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.'}, {'measure': 'Western Ontario and McMaster Universities Arthritis Index (WOMAC)', 'timeFrame': 'Baseline', 'description': 'It is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items):Stiffness (2 items): Physical Function (17 items). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score.Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.'}, {'measure': 'Western Ontario and McMaster Universities Arthritis Index (WOMAC)', 'timeFrame': 'Post 4th week', 'description': 'It is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items):Stiffness (2 items): Physical Function (17 items). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score.Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Balance Training', 'Biodex stability system', 'Osteoarthrosis', 'Degenerative', 'Stability exercises'], 'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '26542683', 'type': 'BACKGROUND', 'citation': "Baldwin SL, Das JP. Atmospheric Ar and Ne returned from mantle depths to the Earth's surface by forearc recycling. Proc Natl Acad Sci U S A. 2015 Nov 17;112(46):14174-9. doi: 10.1073/pnas.1424122112. Epub 2015 Nov 5."}, {'pmid': '12833248', 'type': 'BACKGROUND', 'citation': 'Huang MH, Lin YS, Yang RC, Lee CL. A comparison of various therapeutic exercises on the functional status of patients with knee osteoarthritis. Semin Arthritis Rheum. 2003 Jun;32(6):398-406. doi: 10.1053/sarh.2003.50021.'}, {'pmid': '17666307', 'type': 'BACKGROUND', 'citation': 'Chuang SH, Huang MH, Chen TW, Weng MC, Liu CW, Chen CH. Effect of knee sleeve on static and dynamic balance in patients with knee osteoarthritis. Kaohsiung J Med Sci. 2007 Aug;23(8):405-11. doi: 10.1016/S0257-5655(07)70004-4.'}, {'pmid': '26445646', 'type': 'BACKGROUND', 'citation': 'Eftekhar-Sadat B, Azizi R, Aliasgharzadeh A, Toopchizadeh V, Ghojazadeh M. Effect of balance training with Biodex Stability System on balance in diabetic neuropathy. Ther Adv Endocrinol Metab. 2015 Oct;6(5):233-40. doi: 10.1177/2042018815595566.'}]}, 'descriptionModule': {'briefSummary': 'This was a randomized control Trial, conducted with two group of patients, one has received Balance and stability training on Biodex stability system along with conservative protocol of traditional exercises. the other group has received only conservative protocol of traditional exercises', 'detailedDescription': 'Patients with Symptomatic Knee Osteoarthritis have balance and stability deficits. In routine such patients are not evaluated and treated on balance and stability parameters. So this study was conducted with objectives to determine the effects of Balance training using Biodex stability system in patients with symptomatic knee osteoarthritis.\n\nExperimental group has received Balance and stability training on Biodex stability system along with conservative protocol of traditional exercises.\n\nControl group has received only conservative protocol of traditional exercises.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bilateral knee pain\n* Age 35-65, Both genders\n* Grade 2 or 3 on Kellgren classification for Knee Arthritis\n\nExclusion Criteria:\n\n* Past history of total knee artthroplasty\n* Intra articular steroid injection\n* Rheumatoid Arthritis\n* Use of Assistive devices e.g. canes, walkers and braces\n* Knee injury'}, 'identificationModule': {'nctId': 'NCT04019366', 'briefTitle': 'Balance Training Using Biodex Stability System in Knee Osteoarthritis.', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Balance Training Using Biodex Stability System in Patients With Symptomatic Knee Osteoarthritis.', 'orgStudyIdInfo': {'id': 'RiphahIU Samina Javed'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I', 'description': 'The experimental group was treated with Balance Training on Biodex Stability System along with traditional exercises.', 'interventionNames': ['Other: Balance Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II', 'description': 'The Control group was treated with Traditional exercises only for Symptomatic knee osteoarthritis.', 'interventionNames': ['Other: Conventional Training']}], 'interventions': [{'name': 'Balance Training', 'type': 'OTHER', 'description': 'Experimental group received balance training on Biodex stability System along with traditional exercise program. During balance training on Biodex, patients were instructed to stand on the platform with bare feet with open eyes and both legs supported. Patients were looking forward to screen having hands hang by the sides. The patients were instructed not to change their feet position and balance the body. The handles were accessible for safety point. But touching the handles cancelled the trail. Total time of training was 10 minutes each set is of 3 minutes with 20 sec rest intervals.', 'armGroupLabels': ['Group I']}, {'name': 'Conventional Training', 'type': 'OTHER', 'description': 'Control group has received traditional exercises i.e Quadriceps strength exercises, Hamstrings flexibility exercises and Balance exercises.', 'armGroupLabels': ['Group II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Islamabad', 'country': 'Pakistan', 'facility': 'Armed forces Institute of Rehabilitation Medicine (AFIRM)', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}], 'overallOfficials': [{'name': 'Huma Riaz, PHD*', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}