Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-01-04 @ 7:16 PM
Study NCT ID:
NCT06478069
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postural Assessment of Stroke Patients by Pose Estimation and Effects of Dynamic Core Postural Chain Stabilization
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': 'D002900', 'term': 'Chromosomes, Human, 1-3'}], 'ancestors': [{'id': 'D002877', 'term': 'Chromosomes, Human'}, {'id': 'D033481', 'term': 'Chromosomes, Mammalian'}, {'id': 'D002875', 'term': 'Chromosomes'}, {'id': 'D040342', 'term': 'Genetic Structures'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2024-06-10', 'studyFirstSubmitQcDate': '2024-06-26', 'lastUpdatePostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Berg Balance Scale', 'timeFrame': '12 Months', 'description': "For evaluating balance in a variety of functional tasks, the BBS is a commonly used and validated test. After the intervention period, the BBS scores of the control group and the intervention group (who received DCS techniques) can be compared. The efficacy of DCS in enhancing postural control would be strongly supported by a statistically significant increase in the intervention group's BBS score."}, {'measure': 'Trunk Impairment Scale (TIS) Score', 'timeFrame': '12 months', 'description': 'The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance. In a recent version of the TIS (version 2.0) for adults, the static subscale was removed because of a ceiling effect, total score ranges between 0 and 16 points'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'This study focuses on a two-pronged strategy to enhance the rehabilitation of stroke patients. It first investigates the application of pose estimating technologies to objectively measure posture.', 'detailedDescription': "This can entail capturing a patient's body position with cameras or other sensors in order to detect any imbalances or variations from normal posture brought on by the stroke. The study also looks at how well dynamic core postural chain stabilization (DCS) methods work for stroke recovery. The goal of DCS exercises is to increase stability and strength in the core, which can help with general postural control. This research aims to optimize stroke patient rehabilitation by combining a precise evaluation approach with a focused intervention strategy, which may result in improved balance, movement, and functional abilities."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stroke, either ischemic or hemorrhagic\n* Standing ability and ability to perform basic movements with assistance\n* Willingness to take part in the intervention and evaluations\n\nExclusion Criteria:\n\n* Severe cognitive impairment hindering participation\n* Unstable medical conditions affecting rehabilitation\n* History of other neurological disorders affecting posture'}, 'identificationModule': {'nctId': 'NCT06478069', 'briefTitle': 'Postural Assessment of Stroke Patients by Pose Estimation and Effects of Dynamic Core Postural Chain Stabilization', 'organization': {'class': 'OTHER', 'fullName': 'Superior University'}, 'officialTitle': 'Postural Assessment of Stroke Patients by Pose Estimation and Effects of Dynamic Core Postural Chain Stabilization Techniques', 'orgStudyIdInfo': {'id': 'MSRSW/Batch-Fall22/722'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group A', 'interventionNames': ['Diagnostic Test: Group A']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'interventionNames': ['Behavioral: Group B']}], 'interventions': [{'name': 'Group A', 'type': 'DIAGNOSTIC_TEST', 'description': 'Group A was treated with Ibuprofen Dosage After breakfast and after dinner for 6 weeks.', 'armGroupLabels': ['Group A']}, {'name': 'Group B', 'type': 'BEHAVIORAL', 'description': 'Group B was treated with physical therapy; (Upper limb: The stroke patient warmed up with some gentle stretches for the wrist and fingers to get the muscles ready. They subsequently engaged in resistance training using dumbbells or resistance bands to increase the strength of their upper limbs. Bicep curls, tricep extensions, and shoulder presses were some of these exercises. They tried to complete two to three sets of ten to fifteen repetitions for each exercise, progressively increasing the resistance as their strength increased. Then, to improve dexterity and coordination in daily tasks, functional exercises were included.', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Sevices Hospital Shadman 1', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Superior University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammad Naveed Babur', 'investigatorAffiliation': 'Superior University'}}}}