Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
Study NCT ID:
NCT07283133
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Task Specific Circuit Training on Gross Motor Function, Balance, and Quality of Life in Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-01-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-12-02', 'studyFirstSubmitQcDate': '2025-12-02', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gross motor function', 'timeFrame': '8 week', 'description': 'Gross motor function is measured by GMFM-88. These are the gold-standard tools for evaluating changes in gross motor abilities in CP children. It helps to evaluate changes in motor skills over time or after intervention.\n\nAssesses gross motor functions such as lying, rolling, sitting, crawling, standing, walking, running, and jumping. 80-100% Near-normal motor function / mild CP 40-80% Moderate motor impairment \\< 40% Severe motor impairment'}, {'measure': 'Balance', 'timeFrame': '8 week', 'description': 'Balance is measured by the Pediatric Balance Scale (PBS). Contains 14 tasks such as standing, reaching, turning, and transferring. Scores range from 0 to 5. 50-56 Normal or near-normal balance 33-49 Moderate balance impairment 0-32 Poor balance / high fall risk'}, {'measure': 'Cerebral Palsy Quality of Life', 'timeFrame': '8 week', 'description': 'Quality of life is measured by CP QOL (Cerebral Palsy Quality of Life Questionnaire). It measures domains such as: Social well-being, Emotional well-being, Participation, Pain and disability, Access to services, Family health. Scores range 0-100 \\> 70 High QOL 50-70 Moderate QOL \\< 50 Low QOL'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Balance', 'Gross motor function', 'task-specific circuit training', 'hemiplegic cp'], 'conditions': ['Cerebral Palsy (CP)', 'Quality of Life (QOL)']}, 'descriptionModule': {'briefSummary': 'This study investigates how Task-Specific Circuit Training (TSCT) affects gross motor function, balance, and quality of life in children with Cerebral Palsy. Two groups will be compared: one receiving TSCT and the other receiving conventional physiotherapy. Outcome measures, such as the GMFM, Pediatric Balance Scale, and CP-QoL questionnaire, will be recorded before and after a 8-week intervention (40-50 minutes, 3 sessions per week). Participants will be screened using GMFCS levels I-III. The study aims to determine whether TSCT provides greater improvements in functional mobility, postural control, and overall well-being compared to standard therapy.', 'detailedDescription': 'Cerebral Palsy (CP) is recognized as one of the most common motor disabilities in childhood, significantly affecting movement, balance, and functional independence. Children with CP, particularly those with often experience impairments in gross motor function and postural control, which may limit their participation in daily activities and influence overall quality of life.\n\nThis study will involve two groups, one receiving Task-Specific Circuit Training (TSCT) and the other receiving conventional physiotherapy interventions. This study aims to evaluate the additional effects of task-specific, repetitive, goal-oriented circuit training on gross motor function, balance, and health-related quality of life in children with Cerebral Palsy.\n\nKey outcome measures, including the Gross Motor Function Measure (GMFM-88), Pediatric Balance Scale, and CP-quality of life questionnaire (CP-QoL) will be used to assess improvements in functional mobility, postural stability, and social/psychological well-being. Participants will be screened using the Gross Motor Function Classification System (GMFCS I-III) for inclusion criteria. Outcome measures will be recorded on the first day of intervention, after 4 weeks and again at the completion of the training period.\n\nThe intervention will be administered for 40-50 minutes per session, 3 sessions per week for 6 consecutive weeks, with the TSCT group performing structured, task-oriented functional stations designed to mimic daily life activities, while the control group performs standard physiotherapy exercises. Data will be collected again after 8 weeks to determine the effectiveness of task-specific circuit training in enhancing gross motor function, improving balance, and elevating the overall quality of life in children with Cerebral Palsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of Spastic Hemiplegic Cerebral Palsy.\n* Age range 5-12 years.\n* GMFCS Levels I-III, indicating the ability to walk independently or with assistance.\n* Modified Ashworth Scale score 0 to ≤ 2.\n* Sufficient cognitive ability to participate in training and follow instructions.\n\nExclusion Criteria:\n\n* Modified Ashworth Scale (MAS) score greater than 2 in key muscle groups.\n* GMFCS Levels IV-V, indicating inability to walk.\n* History of frequent seizures.\n* Inability to follow verbal or visual instructions, or presence of severe cognitive impairment.\n* Recent orthopedic surgery or Botulinum Toxin (Botox) injections.\n* Severe musculoskeletal abnormalities such as spinal deformities, hip dislocation, or significant contractures limiting movement.\n* Any respiratory, metabolic, or cardiovascular condition that may limit safe participation.'}, 'identificationModule': {'nctId': 'NCT07283133', 'briefTitle': 'Effects of Task Specific Circuit Training on Gross Motor Function, Balance, and Quality of Life in Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Foundation University Islamabad'}, 'officialTitle': 'Effects of Task Specific Circuit Training on Gross Motor Function, Balance, and Quality of Life in Cerebral Palsy', 'orgStudyIdInfo': {'id': 'FUI/CTR/2025/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Task-specific circuit training (TSCT)', 'description': 'Task-specific circuit training (TSCT) is a high-intensity, progressive programme aimed at improving functional movement through real-life tasks. It consists of 14 workstations, each performing for 1.5 minutes, with a 3-minute rest after completing the full circuit (total \\~21 minutes). Activities include standing and reaching, sit-to-stand, stepping, heel/toe raises, squats, stair climbing, balance exercises, core strengthening, and cycling. This structured circuit enhances gross motor skills, balance, coordination, and overall functional performance.', 'interventionNames': ['Procedure: Experimental Group']}, {'type': 'OTHER', 'label': 'Conventional physical therapy', 'description': 'Conventional physical therapy for both groups will include stretching exercises, strengthening exercises, and positioning techniques.\n\nEach spastic muscle will be stretched to the point of mild discomfort, held for 20 seconds, and repeated five times.\n\nEvery child with CP will be assessed individually to identify spastic muscle groups. Each weak muscle will be trained to contract against resistance, with 10 repetitions performed in each session.\n\nParents will be advised to make their child sit with legs open on a bench or block, ensuring the heels touch the ground. They will also be instructed to have their child stand against a wall with the legs in moderate abduction and external rotation for 15 minutes daily after exercises.', 'interventionNames': ['Procedure: Control Group']}], 'interventions': [{'name': 'Experimental Group', 'type': 'PROCEDURE', 'description': "Task-specific circuit training program consisting of 14 workstations designed to improve gross motor skills, balance, strength, and functional mobility. Each station includes a specific functional task-such as reaching, sit-to-stand, stepping in different directions, heel-to-toe raises, squatting, straight-leg raises, stair climbing, backward walking, balance-beam walking, core exercises, bridges, opposite-arm/leg raises, side-bridge exercises, and stationary cycling. Progression at each station is achieved by increasing difficulty through adjustments such as varying distances or heights, increasing repetitions, adding weights, altering surfaces (firm/soft), increasing movement speed, reducing squat depth, carrying objects during tasks, or increasing resistance (for cycling). Overall, the program gradually challenges the child's balance, strength, coordination, and motor control by systematically modifying task demands.", 'armGroupLabels': ['Task-specific circuit training (TSCT)']}, {'name': 'Control Group', 'type': 'PROCEDURE', 'description': 'Conventional physical therapy will include stretching, strengthening, and positioning exercises. Spastic muscles will be stretched to mild discomfort, held for 20 seconds, and repeated five times. Weak muscles will be strengthened with 10 resisted contractions per session. Parents will be advised to seat the child with legs apart on a bench/block with heels supported and to practice wall-standing with legs moderately abducted and externally rotated for 15 minutes daily after exercises.', 'armGroupLabels': ['Conventional physical therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Islamabad', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Kiran Khushnood, MS-NMPT', 'role': 'CONTACT', 'email': 'kiran.khushnood@fui.edu.pk', 'phone': '+92 3335993417'}], 'facility': 'Foundation University College of Physical Therapy', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}], 'centralContacts': [{'name': 'Kiran Khan, DPT', 'role': 'CONTACT', 'email': 'kirankhere94@gmail.com', 'phone': '+92 3315070129'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation University Islamabad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}