Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-26 @ 5:11 PM
Study NCT ID:
NCT06905457
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-01
First Post:
2025-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effect of Vojta Therapy and Bobath Therapy on Lower Limb Spasticity and Motorcity Among HS
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2025-03-25', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer Assessment scale(FMA)', 'timeFrame': '12 Months', 'description': 'The total possible scale score is 226. Points are divided among the domains as follows: Motor score: ranges from 0 (hemiplegia) to 100 points (normal motor performance). Divided into 66 points for upper extremity and 34 points for the lower extremity.'}, {'measure': 'Modified ashworth scale( MAS)', 'timeFrame': '12 Months', 'description': "The Modified Ashworth Scale (MAS) is a clinical tool used to measure spasticity, a velocity-dependent increase in muscle stretch reflexes, by assessing the resistance to passive movement. It's a six-level ordinal scale, ranging from 0 (no increase in tone) to 4 (affected part rigid)"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Background: Stroke is clinical defined as a neurological syndrome characterized by acute disruption of blood flow to an area of brain and corresponding onset of neurological defects related to the concerned area of brain. Hemiplegic patient primarily affects the upper limb and lower limb of one side and typically results in flaccidity and difficulties with motor control and function.', 'detailedDescription': "The aim of this study will compare the Effect of Vojta therapy and Bobath therapy on lower limb spasticity and motorcity among hemiparetic stroke patients. Methodology: Randomize clinical trials will be carried out on lower limb spasticity and motorcity among hemiparetic stroke patients. This study will include adult's stroke (1-4 months post- onset). Inclusion criteria in which diagnosed with hemiplegic patients, aged 25-75 years and willingness to participants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with Hemiparetic stroke.\n* adult\'s stroke (1-4 months post- onset)\n* Ability to follow instructions and participate in testing\n* Aged 25-75 years.\n\nExclusion Criteria:\n\n* Previous history of brain surgery.\n* Pregnant women.\n* Limitation in cognitive skills like Aphasia, deteriorated consciousness or dementia.\n* Severe cardiovascular disease (unstable hypertension)"'}, 'identificationModule': {'nctId': 'NCT06905457', 'briefTitle': 'Comparative Effect of Vojta Therapy and Bobath Therapy on Lower Limb Spasticity and Motorcity Among HS', 'organization': {'class': 'OTHER', 'fullName': 'Superior University'}, 'officialTitle': 'Comparative Effect of Vojta Therapy and Bobath Therapy on Lower Limb Spasticity and Motorcity Among Hemiparetic Stroke Patients', 'orgStudyIdInfo': {'id': 'MSRSW/Batch-Fall23/786'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vojta therapy', 'interventionNames': ['Combination Product: Vojta therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Bobath therapy', 'interventionNames': ['Combination Product: Bobath therapy']}], 'interventions': [{'name': 'Vojta therapy', 'type': 'COMBINATION_PRODUCT', 'description': 'Vojta therapy, also known as Reflex Locomotion Therapy, is a specialized physiotherapy technique developed by Czech neurologist Václav Vojta, using sensory stimulation to activate innate movement patterns and improve motor skills, posture, and overall function', 'armGroupLabels': ['Vojta therapy']}, {'name': 'Bobath therapy', 'type': 'COMBINATION_PRODUCT', 'description': 'Bobath therapy, also known as Neurodevelopmental Treatment (NDT), is a problem-solving approach to neurological rehabilitation, focusing on motor learning and efficient motor control to improve function and participation in daily activities', 'armGroupLabels': ['Bobath therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Faisalābad', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Aqsa physiotherapy clinic, Main Sheikhupura road near Sitara Velly'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Superior University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammad Naveed Babur', 'investigatorAffiliation': 'Superior University'}}}}