Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-02-04 @ 9:05 PM
Study NCT ID:
NCT05915195
Status:
COMPLETED
Last Update Posted:
2023-12-05
First Post:
2023-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Postural and Kinesthetic Awareness on Static Standing Balance in Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-03', 'studyFirstSubmitDate': '2023-04-14', 'studyFirstSubmitQcDate': '2023-06-13', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Static Component of Berg Balance Scale', 'timeFrame': '6 months', 'description': 'Static component of Berg Balance Scale was used to measure static standing balance. Total score of berg balance scale is 56. A score of 56 indicates functional balance.A score of \\< 45 indicates individuals may be at greater risk of falling.'}, {'measure': 'PoData Stabiliometric Plate', 'timeFrame': '6 months', 'description': 'PoData stabiliometric plate was used for the static plantar pressure evaluation. It recorded statistics of plantar pressure.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'static balance', 'plantar pressure', 'postural and kinestetic awareness', 'PoData Stabiliometeric plate'], 'conditions': ['Chronic Stroke']}, 'referencesModule': {'references': [{'pmid': '39407366', 'type': 'DERIVED', 'citation': 'Rauf W, Sarmad S, Liaqat S, Saleem S, Jawad M, Ahad M. Effects of postural and kinesthetic awareness on static standing balance and plantar pressure in chronic stroke: a randomized controlled trial. J Pak Med Assoc. 2024 Oct;74(10):1755-1760. doi: 10.47391/JPMA.10538.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this randomized controlled trial is to check the effects of postural and kinesthetic awareness on static standing balance in chronic stoke patients. Participants will be divided into two equal groups. One group will receive routine physical therapy while other group will receive postural and kinesthetic awareness in addition to routine physical therapy.', 'detailedDescription': 'To determine effects of Postural and kinesthetic awareness on plantar pressure and static standing balance in chronic stroke patients. The study was conducted at the University of Lahore Teaching Hospital in the Department of Pediatric Physical Therapy \\& Neuro Rehabilitation Center. Total 62 stroke patients with visual spatial neglect were enrolled in this study, patients were equally assigned into control and experimental group. Control group received routine physical therapy while experimental group received routine physical therapy and postural and kinesthetic awareness program. Static component of berg balance scale and PoData Stabiliometeric plate was used for measurement of balance and plantar pressure respectively'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic stroke patient\n* Both genders\n* Age: 45-60 years\n* 9 score or higher on static part of Berg Balance Scale\n* Level 1 and 2 of Modified Ashworth Scale\n* 24 or more score on Mini mental state scale\n\nExclusion Criteria:\n\n* Patients with\n\n * Psychological diseases\n * Dementia\n * Orthopedic disorders\n * Any insufficiency that can influence balance'}, 'identificationModule': {'nctId': 'NCT05915195', 'briefTitle': 'Effects of Postural and Kinesthetic Awareness on Static Standing Balance in Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University of Lahore'}, 'officialTitle': 'Effects of Postural and Kinesthetic Awareness on Static Standing Balance and Planter Pressure by Using PoData Stabiliometric Plate in Stroke', 'orgStudyIdInfo': {'id': 'REC-UOL-70-02-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Routine Physical Therapy', 'description': 'routine physical therapy including range of motion exercises (Active assisted), stretching exercises, strengthening and positioning. Daily session was of 1 hour, 5 times weekly for 6 weeks.', 'interventionNames': ['Other: Routine Physical Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Routine Physical Therapy and Postural and Kinesthetic Awareness', 'description': 'routine physical therapy and additionally postural and kinesthetic Awareness in front of mirror by emphasizing proper body positioning, movements \\& balance in sitting and standing position by using interoceptive and exteroceptive reinforcement (verbal, tactile \\& visual).', 'interventionNames': ['Other: Postural and Kinesthetic Awarness']}], 'interventions': [{'name': 'Postural and Kinesthetic Awarness', 'type': 'OTHER', 'otherNames': ['Experimental Group'], 'description': 'Firstly, patient performed therapeutic activities/exercise to achieve balance in sitting position using chair with arm rest and with planted feet then progressed to sitting on chair without arm rest with proper feet placement. Once the patient achieved balance in sitting on chair then shifted to sitting on the stool and later standing in parallel bar that leads to balance training in independent standing.', 'armGroupLabels': ['Routine Physical Therapy and Postural and Kinesthetic Awareness']}, {'name': 'Routine Physical Therapy', 'type': 'OTHER', 'otherNames': ['Control Group'], 'description': 'Range of motion exercises (Active assisted), stretching exercises, strengthening and positioning.', 'armGroupLabels': ['Routine Physical Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'The University of Lahore Teaching Hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Sameed Liaquat, MSPTN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Lahore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lahore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prinicipal Investigator', 'investigatorFullName': 'Safa Saleem', 'investigatorAffiliation': 'University of Lahore'}}}}