Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-25 @ 4:14 PM
Study NCT ID:
NCT06674057
Status:
RECRUITING
Last Update Posted:
2024-11-05
First Post:
2024-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Additional Effects of Kinesio-Taping Along with Conservative Physical Therapy on Upper Limb Function, Range of Motion and Spasticity in the Patients with Subacute Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009128', 'term': 'Muscle Spasticity'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central 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': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-01-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-04', 'studyFirstSubmitDate': '2024-11-04', 'studyFirstSubmitQcDate': '2024-11-04', 'lastUpdatePostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spasticity', 'timeFrame': '6 weeks', 'description': 'velocity dependant passive resistance to stretch will be assesed using the modified ashworth scale.'}, {'measure': 'Upper limb function', 'timeFrame': '6 weeks', 'description': 'Upper limb function will be assessed using the wolf motor function test for upper limb.'}], 'secondaryOutcomes': [{'measure': 'Range of motion', 'timeFrame': '6 weeks', 'description': 'range of motion of Wrist, Elbow and shoulder joint will be assessed using a goiniometer.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke.', 'subacute stroke', 'kinesio taping', 'proprioceptive neuromuscular facilitation', 'Upper limb function.', 'range of motion'], 'conditions': ['Subacute Stroke', 'Upper Limb', 'Range of Motion', 'Spasticity', 'CVA (Cerebrovascular Accident)', 'KINESIOTAPING', 'Stroke', 'Function']}, 'descriptionModule': {'briefSummary': 'A randomized control trial will be done on diagnosed stroke patients of subacute stage in Fauji Foundation Hospital Rawalpindi and leading edge physical therapy and rehabilitation clinic.The purpose of the study is to determine Additional Effects of Kinesio-Taping along with conservative Physical Therapy on upper limb function, Range of motion and Spasticity in the patients with Subacute Stroke. The conservational physical therapy includes Passive and active ROMs 25 repetitions each, 3 times per week. PNF stretching (hold relax) for spastic muscles for 20 repetitions with a 10 second hold and 10 second relaxation of the muscle group 3 times per week.\n\nD1 flexion and extension for 20 repetitions 3 times per week. Kinesio tape 3 times per week. (Anchor opposed to effected compartment to provide facilitation and sustained stretch). with srtrngth training included in week 3-6 with a resistance band of medium resistance.\n\ntreatment time will be 30 minutes on alternate days for six weeks.', 'detailedDescription': 'OBJECTIVES:\n\nThe objectives of this study are:\n\n1. To determine the additional effects of kinesio taping in combination with physical therapy on ROM of upper limb shoulder, elbow and wrist joint in subacute stroke patients\n2. To determine the additional effects of kinesio taping in combination with physical therapy on upper limb spasticity in subacute stroke patients\n3. To determine the effects of kinesio taping on upper limb function in subacute stroke patients.\n\nHYPOTHESIS:\n\nAlternate Hypothesis:\n\nThere is a statistically significant difference between kinesio taping combined with physical therapy on ROM, spacticity and function of upper limb Shoulder, elbow and wrist joints in patients with subacute stroke compared to conventional physical therapy.\n\nNull Hypothesis:\n\nThere is no statistically significant difference between kinesio taping combined with physical therapy on ROM, spacticity and function of upper limb Shoulder, elbow and wrist joints in patients with subacute stroke compared to conventional physical therapy.\n\nResearch Design: Experimental study. Randomized Control Trial\n\nClinical setting: Rehabilitation department, Fauji Foundation Hospital , leading edge physical therapy and rehabilitation islamabad.\n\nStudy duration: 6 months.\n\nSelection Criteria:\n\nInclusion Criteria\n\n* Age group: 40-65 years onwards\n* Both males and females\n* Patients with history of diagnosed stroke and lie within subacute stage of stroke\n* MAS scale score of 1\\_2\n\nExclusion Criteria\n\n* Any congenital deformities\n* cognitive deficits\n* Fractures\n* Upper limb surgery\n\nSampling technique: Convenience sampling\n\nOutcome Measures:\n\nData will be collected on Demographics and general information Goniometer will be used to assess the range of motion of shoulder, elbow and wrist joint Modified Ashworth scale will be used to determine the level of spasticity in the participants.\n\nWolf motor function test scale for upper limb will be used to assess upper limb function.\n\nExperimental Group (A) = This group will receive kinesio taping every alternate day for six weeks combined with conservational physical therapy which includes AROMs, PROMs, PNF D1 flexion and extension, resistance raining using resistance band of medium resistane.\n\nand their outcomes will be measured at baseline and at 3rd week and at the end of 6th week treatment.\n\nControl group (B) =this group will not receieve kinesio taping , only conservationall Physical therapy will be given and their outcomes will be observed at the baseline, at third week and then after treatment of 06 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\nA printed questionnaire will be provided to the participents after obtaining written consent and providing adequate explanation regarding the study, after which the data will be presented in the form of graphs or tables.\n\nSignificance of the study:\n\nThis study will add data to the literature. Providing evidence-based data and aiding healthcare providers to incorporate kinesio taping as an adjunct intervention.\n\nThis study will also provide a feasible and cost-effective treatment to the patient diagnosed with subacute stroke.\n\nKinesio taping is easy to apply, potentially beneficial treatment options for patients with subacute stroke upper limb dysfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age group: 40-65 years onwards\n* Both males and females\n* Patients with history of diagnosed stroke and lie within subacute stage of stroke\n* MAS scale score of 1\\_2\n\nExclusion Criteria:\n\n* Any congenital deformities\n* cognitive deficits\n* Fractures\n* Upper limb surgery'}, 'identificationModule': {'nctId': 'NCT06674057', 'briefTitle': 'Additional Effects of Kinesio-Taping Along with Conservative Physical Therapy on Upper Limb Function, Range of Motion and Spasticity in the Patients with Subacute Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Foundation University Islamabad'}, 'officialTitle': 'Additional Effects of Kinesio-Taping Along with Conservative Physical Therapy on Upper Limb Function, Range of Motion and Spasticity in the Patients with Subacute Stroke', 'orgStudyIdInfo': {'id': 'FUI/CTR/2024/42'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': "It includes participants receiving kinesio taping in addition to conservational physical therapy for subacute stroke patient's upper limb ROM/spasticity/function. for a period of 6 weeks.", 'interventionNames': ['Procedure: KinesioTaping']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': "It includes participants receiving conservational physical therapy for subacute stroke patient's upper limb ROM/spasticity/function. for a period of 6 weeks.", 'interventionNames': ['Procedure: Control']}], 'interventions': [{'name': 'KinesioTaping', 'type': 'PROCEDURE', 'description': 'The experimental group will receive the following treatment for week 1-3 (3 days on alternate days):\n\n* Passive and active ROMs 25 repetitions each, 3 times per week.\n* PNF stretching (hold relax) for spastic muscles for 20 repetitions with a 10 second hold and 10 second relaxation of the muscle group 3 times per week.\n* D1 flexion and extension for 20 repetitions 3 times per week.\n* Kinesio tape 3 times per week. (Anchor opposed to effected compartment to provide facilitation and sustained stretch).\n\nFor week 3-6 the treatment will include:\n\n* Passive and active ROMs 25 repetitions each, 3 times per week.\n* PNF stretching (hold relax) for spastic muscles for 20 repetitions with a 10 second hold and 10 second relaxation of the muscle group 3 times per week.\n* D1 flexion and extension for 20 repetitions 3 times per week.\n* Strengthening affected muscle groups by resistance training, 3 times per week (using a resistance band of mediu', 'armGroupLabels': ['experimental group']}, {'name': 'Control', 'type': 'PROCEDURE', 'description': 'The control group will receive the following treatment for week 1-3 on alternate days:\n\n* Passive and active ROMs 25 repetitions each, 3 times per week.\n* PNF stretching (hold relax) for spastic muscles for 20 repetitions with a 10 second hold and 10 second relaxation of the muscle group 3 times per week.\n* D1 flexion and extension for 20 repetitions 3 times per week.\n\nFor week 3-6 the treatment will include:\n\n* Passive and active ROMs 25 repetitions each, 3 times per week.\n* PNF stretching (hold relax) for spastic muscles for 20 repetitions with a 10 second hold and 10 second relaxation of the muscle group 3 times per week.\n* D1 flexion and extension for 20 repetitions 3 times per week.\n* Strengthening affected muscle groups by resistance training, 3 times per week (using a resistance band of medium resistance).', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Islamabad', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Sana Bashir, MS-CPT, PhD*', 'role': 'CONTACT', 'email': 'drsana.bashir@fui.edu.pk', 'phone': '003218529475'}], 'facility': 'Foundation University College of Physical Thrapy', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}], 'centralContacts': [{'name': 'SOHAIB AHMAD, DPT', 'role': 'CONTACT', 'email': 'sohaib3636@gmail.com', 'phone': '+923158054156'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation University Islamabad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}