Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-01 @ 1:44 PM
Study NCT ID:
NCT05059704
Status:
COMPLETED
Last Update Posted:
2023-01-17
First Post:
2021-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Circuit Class Training vs. Individual, Task Specific Training in Chronic Stroke Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009128', 'term': 'Muscle Spasticity'}], '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'}, {'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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-13', 'studyFirstSubmitDate': '2021-09-17', 'studyFirstSubmitQcDate': '2021-09-17', 'lastUpdatePostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer Assessment Scale', 'timeFrame': '8 weeks', 'description': 'The Fugl-Meyer Assessment is the gold standard to assess motor function of post-stroke hemiparesis. The Fugl-Meyer Upper Extremity (FMUE) Scale is a widely used and highly recommended stroke-specific, performance-based measure of impairment. It is designed to assess reflex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia.'}], 'secondaryOutcomes': [{'measure': 'Modified Ashworth Scale', 'timeFrame': '8 weeks', 'description': 'The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone. The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion, which does not require any instrumentation and is quick to perform'}, {'measure': 'Stroke Specific-Quality of Life Urdu Version (SS-QOL)', 'timeFrame': '8 weeks', 'description': 'The SS-QOL scale is a health-related outcome measure that comprises 49 items in 12 areas of vision, mobility, thinking, social roles, self-care, language, personality, family roles, work/productivity, upper limb function, mood and energy. It covers a more extensive inclusion of capacities ordinarily influenced by stroke.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spasticity', 'Motor function'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': "Due to minimal volitional activation of the impaired arm, these individuals are less able to engage in activities of daily living (ADL's). Moreover, simultaneous use of the hand and arm are needed throughout ADL's. The effects of these two approaches (circuit class training and individual task-specific training) on upper extremity function and activities of daily living (ADL's) have not yet been clearly identified, and studies on its effects on chronic stroke patients are limited.", 'detailedDescription': 'several research found that circuit training improved various functional parameters after stroke. And most of the circuit based tasks from the published studies were focused on the leg strength, walking speed, distance and balance etc. Previous literature found that circuit class training is effective in improving upper extremity function in chronic stroke patients disregarding the type of stroke and the results of that study are not generalized for chronic stroke patients with upper extremity deficit. Secondly, circuit class training and task-specific training are effective for improving upper limb function following a stroke but in the acute stage. In fact, there is no evidence in which comparison of these two approaches has been done in chronic stroke patients and thirdly, between these two approaches which approach is more effective towards improving upper limb function in chronic stage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mini-Mental State Examination score more than 24\n* Chronic stage (i.e. post-stroke duration of 6 months)\n* Single episode of stroke\n* MAS of 1 to 3 at upper extremity.\n* MRS of ≤ 3 at lower extremity.\n* MCA stroke\n* Scores 32 to 47 on Fugl-Meyer Upper Extremity Scale (FMA-UE)\n\nExclusion Criteria:\n\n* Orthopedic conditions that affect the UE function.\n* Other neurological conditions, like PD, MS etc.'}, 'identificationModule': {'nctId': 'NCT05059704', 'briefTitle': 'Circuit Class Training vs. Individual, Task Specific Training in Chronic Stroke Patient', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Circuit Class Training vs. Individual, Task Specific Training on Upper Extremity Function in Chronic Stroke Patient', 'orgStudyIdInfo': {'id': 'REC/01036 Farwa Azmat'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Circuit Class Training', 'description': "Patients will participate in a total of 1.5hour/day for 8 weeks with a 1:3 (therapist to patient). The circuit will be divided into 5 specific stations, 5 to 10 minutes for warm-up tasks and 15 to 20 minutes on each station as tailored to the patient's activity level", 'interventionNames': ['Other: Circuit Class Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Individual Task specific training', 'description': 'Patients will participate in a total of 1.5hour/day for 8 weeks with 1:1 (therapist to patient) ratio. During each session, all patients will perform 5 to 10 minutes warm-up tasks, then practiced the selected tasks for the rest of the time.', 'interventionNames': ['Other: Individual Task specific training']}], 'interventions': [{'name': 'Circuit Class Training', 'type': 'OTHER', 'description': "Station 1 will include tasks for warm-up specific for upper extremity, station 2 will include shoulder exercises, station 3 will include elbow exercises, station 4 will include wrist exercises and station 5 will include hand activities and functional training. Variables such as speed, or/and resistance will progressively increase in difficulty according to each patient's ability.", 'armGroupLabels': ['Circuit Class Training']}, {'name': 'Individual Task specific training', 'type': 'OTHER', 'description': "Variables such as speed, or/and resistance will progressively increase in difficulty according to each patient's ability.", 'armGroupLabels': ['Individual Task specific training']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dhok Gujra', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Al Mustafa Trust Medical and Physiotherapy Centre', 'geoPoint': {'lat': 32.98068, 'lon': 73.51354}}], 'overallOfficials': [{'name': 'Mirza Obaid Baig, MSPT(NMR)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}