Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-03 @ 6:45 PM
Study NCT ID:
NCT06749002
Status:
RECRUITING
Last Update Posted:
2024-12-27
First Post:
2024-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Additional Effects of Functional Muscle Training With Turning Based Specific Training During Turning in Post Stroke Patients
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-01-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2024-12-19', 'studyFirstSubmitQcDate': '2024-12-19', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Turning performance.', 'timeFrame': '6 weeks', 'description': 'Standing turn test will be used for turning performance'}, {'measure': 'turning ability', 'timeFrame': '6 weeks', 'description': 'Figure of 8 test will be used for turning ability'}, {'measure': 'Balance', 'timeFrame': '6 weeks', 'description': 'Berg Balance Scale will be used to assess balance'}, {'measure': 'Balance', 'timeFrame': '6 weeks', 'description': 'Four square stand test will be used for this'}], 'secondaryOutcomes': [{'measure': 'Balance', 'timeFrame': '6 weeks', 'description': 'Timed up and go test will be used for this'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'chronic stroke', 'functional muscle training', 'Turning based specific training', 'Turning in Gait'], 'conditions': ['Subacute Stroke', 'Chronic Stroke', 'Balance']}, 'descriptionModule': {'briefSummary': 'Stroke is the leading cause of disability leading to Gait and balance dysfunction leading to decreased Quality of Life. Difficulty in turning is a major target in Gait Rehabilitation. Task specific exercises has proven to be effective in all stages of stroke rehabilitation, therefore Turning based specific training is to be used in order to improve turning and balance in post stroke patients moreover functional strength training of lower extremities prove to be more effective than traditional training.', 'detailedDescription': 'The objectives of this study are:\n\n1. To determine the additional effects of functional muscle training with turning based specific training on turning in Gait among post stroke patients.\n2. To the determine the additional effects of functional muscle training with turning based specific training on balance in post stroke patients.\n3. To determine the additional effects of functional muscle training with turning based specific training on Quality of LIfe aming post stroke patients.\n\nHYPOTHESIS:\n\nAlternate hypothesis 1.1HA-There will be a statistically significant difference of muscle training in addition with turning based specific training in turning among post stroke patients (p\\<0.05).\n\n2\\. 2HA- There will be statistically significant difference between muscle training in addition with turning based specific training on balance in post stroke patients (p\\<0.05).\n\nNull hypothesis:\n\n1.1H0 -There will be statistically no significant difference of muscle training with turning based specific training on turning in Gait among post-stroke patients (p\\>0.05) 2 .2HO-There will be statistically no significant difference of muscle training with turning specific training on balance in post stroke patients (p\\>0.05)Research Design: Experimental study. Randomized Control Trial\n\nClinical setting: Rehabilitation department, Fauji Foundation Hospital.\n\nSelection Criteria:\n\nInclusion Criteria\n\n* Age group: 45-60 years onwards\n* Both males and females\n* Patients with subacute and chronic stroke (MCA \\>6months)\n* MMSE- 25 or higher, Functional ambulatory capacity-3\n\nExclusion Criteria\n\n* Hemorrhagic stroke.\n* Patients with epilepsy\n* Patients with other neurological conditions loke Alzheimer, parkinsons and dementias.\n\nSampling technique: non-probability purposive sampling.\n\nOutcome Measures:\n\nTURNING: 1) Standing Turn Test, 2) Figure of 8 Test. BALANCE: 1) Berg Balance Scale, 2) Timed up and Go Test, 3) Modified 4 square step Test.\n\nOutcome measures will be evaluated at baseline and then after 6 weeks of intervention.\n\nExperimental Group (A) = This group will recieve Turning based specific training along with Functional muscle training for 6 weeks.\n\nControl group (B) = This group will recieive Turning Based Specific Training only for 6 weeks\n\nData analysis techniques:\n\nThe data will be analyzed through SPSS 21 and Data would be analyzed based on the study design chosen that is random control experimental study.\n\nSignificance of the study:\n\nTurning is a major component of ambulation. Difficulty in turning results in increased risk of fall. Stroke results in step asymmetry which increases difficulty in changing direction.\n\nThere is sufficient evidence available for normal gait training but limited protocols for targetting turning in Gait.\n\nThe current study aims to fill this gap by providing research data and developing a treatment protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age group: 45-60 years onwards\n* Both males and females\n* Subacute and chronic stroke (MCA \\>6months)\n* MMSE score 25 or higher.\n* FAC -3\n\nExclusion Criteria:\n\n* Hemorrhagic stroke.\n* Patients with Epilepsy.\n* Patients with other neurological conditions like Alzheimer, Parkinson and other Dementias.'}, 'identificationModule': {'nctId': 'NCT06749002', 'briefTitle': 'Additional Effects of Functional Muscle Training With Turning Based Specific Training During Turning in Post Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Foundation University Islamabad'}, 'officialTitle': 'Additional Effects of Functional Muscle Training With Turning Based Specific Training During Turning in Post Stroke Patients', 'orgStudyIdInfo': {'id': 'FUI/CTR/2024/61'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'It includes participants receiving Functional muscle training along with Turning based specific training over a period of 6 weeks.', 'interventionNames': ['Procedure: Turning based specific training along with functional Muscle training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'It includes participants recieving Turning based specific training only for 6 weeks.', 'interventionNames': ['Procedure: turning based specific training.']}], 'interventions': [{'name': 'Turning based specific training along with functional Muscle training', 'type': 'PROCEDURE', 'description': 'Experimental group will receive Turning based specific training protocol for 6 weeks along with functional muscle training, training will be done on alternate days.\n\nFunctional muscle training:\n\nDetails: Week 1-6: 3 days a week on alternate days.\n\nHip Abductors:\n\nSide lying leg raises Single leg squatting Standing leg wall press Progressing to Adding resistance bands\n\nHip adductors:\n\nSide lying adduction Standing Adduction Progress to adding resistance bands\n\nHip Flexors:\n\nStanding leg lift Straight leg raises Progress to adding resistance bands\n\nHip Extensors:\n\nProne lying raises Standing single leg extension Progress to adding resistance bands\n\nPlantarflexors/ DorsiFlexors:\n\nPlantarflexors:\n\nPlantarflexion against resistance Toe raises\n\nDorsiflexors:\n\nDorsiflexion against resistance Heel raises\n\nHip external rotators:\n\nSitting-externally rotate hip 0-30° Add resistance bands\n\nHip Internal rotators:\n\nSitting-internally rotate the hip 0-30° Add resistance bands.', 'armGroupLabels': ['Experimental group']}, {'name': 'turning based specific training.', 'type': 'PROCEDURE', 'description': 'Week 1:\n\n90 Degrees turns on the spot\n\nVisual cues to follow\n\nWeek 2-3:\n\n90 degrees turns on the spot\n\nFigure of 8 walking\n\nVisual cues to follow\n\nWeek 4-5:\n\n90 Degrees turns on the spot\n\nFigure of 8 walking\n\nStep across body\n\nBraiding\n\nWeek 6:\n\n90 degree turns on the spot\n\nFigure of 8 walking\n\nStep across body\n\nBraiding\n\nVisual cues to follow\n\nObstacle avoidance', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Islamabad', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Sana Khalid, MS-NMPT', 'role': 'CONTACT', 'email': 'sana.khalid@fui.edu.pk', 'phone': '+92 3444218174'}], 'facility': 'Foundation University College of Physical Therapy', 'geoPoint': {'lat': 29.7426, 'lon': 73.14353}}], 'centralContacts': [{'name': 'Mahnoor Khan, DPT', 'role': 'CONTACT', 'email': 'imahnoorphysio28@gmail.com', 'phone': '+92 3331979569'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation University Islamabad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}