Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-01-01 @ 1:14 AM
Study NCT ID:
NCT04232995
Status:
COMPLETED
Last Update Posted:
2021-08-19
First Post:
2020-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Balance Training in Diabetic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-18', 'studyFirstSubmitDate': '2020-01-11', 'studyFirstSubmitQcDate': '2020-01-15', 'lastUpdatePostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Berg Balance Scale', 'timeFrame': 'Baseline (Pre treatment)', 'description': 'The Berg Balance Scale (BBS) is a 56-point scale that evaluates 14 tasks. Katherine Berg developed this test to assess the level of function and balance in various patient populations. Minimum score is 0 (means severe balance deficit) and Maximum score is 56 (means No balance deficit)'}, {'measure': 'Berg Balance Scale', 'timeFrame': 'At 4th week of treatment', 'description': 'The Berg Balance Scale (BBS) is a 56-point scale that evaluates 14 tasks. Katherine Berg developed this test to assess the level of function and balance in various patient populations. Minimum score is 0 (means severe balance deficit) and Maximum score is 56 (means No balance deficit)'}, {'measure': 'Berg Balance Scale', 'timeFrame': 'At 8th week of treatment (Post treatment )', 'description': 'The Berg Balance Scale (BBS) is a 56-point scale that evaluates 14 tasks. Katherine Berg developed this test to assess the level of function and balance in various patient populations. Minimum score is 0 (means severe balance deficit) and Maximum score is 56 (means No balance deficit)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus type 2', 'Diabetic neuropathy', 'Rehabilitation', 'Balance exercises', 'Berg Balance Scale'], 'conditions': ['Diabetic Neuropathy With Neurologic Complication']}, 'descriptionModule': {'briefSummary': 'This study evaluates the efficacy of balance training in Diabetic Neuropathy. Control group will receive general exercises while Eperimental/ Interventional group will receive Balance exercises along with general exercises.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age group: 30-60 years\n* Diabetes type II patients diagnosed with peripheral neuropathy by medical doctor for at least 5 years\n* Neuropathy present (on the basis of Michigan Neuropathy Screening Instrument\n* Have balance impairment ( evaluation on Berg Balance Scale)\n\nExclusion Criteria:\n\n* Neuropathy due to other medical conditions like Vitamin deficiency, Hypothyroidism, Auto-immune/ demyelinating diseases\n* Foot ulcers\n* Lower limb amputee\n* Vestibular diseases\n* Retinopathy\n* Cardiac problems\n* Hemiplegia/ Stroke'}, 'identificationModule': {'nctId': 'NCT04232995', 'briefTitle': 'Balance Training in Diabetic Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Dow University of Health Sciences'}, 'officialTitle': 'Efficacy of Balance Training in Comparison to General Exercises Alone in Diabetic Neuropathy', 'orgStudyIdInfo': {'id': 'RTazeem'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Balance training by 9 positions with 1 min hold, repeated twice\n\n1. Stand with feet together, eyes remain open\n2. Stand with together, eyes closed\n3. \\& 4) Tandem Standing with Right and Left in front alternately\n\n5\\) Forward Reaching 6) \\& 7) Single Leg Standing, with Right and Left foot alternately 8) \\& 9) Step up, with Right and Left foot alternately\n\nGeneral Exercises for 25 min\n\n* Active Range of Motion Exercises and Foot Care Education-5 min\n* Treadmill- 15 min\n* Cycling -5 min\n\nNo. Of Sessions 24, thrice a week for 8 weeks', 'interventionNames': ['Other: Balance Training', 'Other: General Exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'General Exercises for 25 min\n\n* Active Range of Motion Exercises and Foot Care Education-5 min\n* Treadmill- 15 min\n* Cycling -5 min\n\nNo. Of Sessions 24, thrice a week for 8 weeks', 'interventionNames': ['Other: General Exercises']}], 'interventions': [{'name': 'Balance Training', 'type': 'OTHER', 'description': 'Balance enhancing exercises', 'armGroupLabels': ['Experimental Group']}, {'name': 'General Exercises', 'type': 'OTHER', 'description': 'General Exercises', 'armGroupLabels': ['Control Group', 'Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74200', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Institute of Physical Medicine and Rehabilitation, Dow University of Health Sciences', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dow University of Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rabeiya Tazeem', 'investigatorAffiliation': 'Dow University of Health Sciences'}}}}