Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-05 @ 7:56 AM
Study NCT ID:
NCT07474818
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Loaded and Task Specific Training in Spastic Diaplegic CP to Improve Gait and Functional Mobility.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537945', 'term': 'Cerebral palsy, spastic, diplegic'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Not Needed'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-14', 'studyFirstSubmitDate': '2026-03-08', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Gait Parameter: Cadence', 'timeFrame': 'Baseline and after 6 weeks', 'description': 'Cadence, defined as the step rate or rhythm of the walk, will be measured in steps per minute. This data will be collected and analyzed using the Jakcs Observational Gait Analysis, a 66-item clinical evaluation checklist designed to systematically observe, identify, and document abnormalities or deviations in patient walking patterns.'}, {'measure': 'Change in Gait Parameter: Velocity', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Walking velocity (speed) will be measured in meters per minute. This parameter will be assessed and documented using the abbreviated 66-item Jakcs Observational Gait Analysis checklist.'}, {'measure': 'Change in Gait Parameter: Stride Length', 'timeFrame': 'Baseline and after 6 weeks', 'description': 'Stride length, which is the measurement of the forward distance covered during two successive points of contact made by the same foot, will be measured in meters. This will be recorded using the Jakcs Observational Gait Analysis tool.'}, {'measure': 'Change in Functional Mobility', 'timeFrame': 'Baseline and after 6 weeks', 'description': 'Functional mobility will be assessed using Dimension E (Walking, Running \\& Jumping) of the Gross Motor Function Measure-88 (GMFM-88). The GMFM-88 is a standardized observational instrument designed to assess functional mobility in children with cerebral palsy. It has five dimensions. The items in Dimension E are scored, and the total is calculated by averaging these percentages, where a higher percentage indicates better functional mobility and independence.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spastic Cerebral Palsy', 'Gait Training', 'Functional Mobility', 'Loaded Treadmill Training', 'Task Specific Training', 'Gross Motor Function'], 'conditions': ['Spastic Diplegia Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'Cerebral Palsy is a non-progressive condition caused by early brain injury that affects movement, posture, and muscle tone. Spastic diplegia mainly involves the lower limbs, leading to stiffness, weakness, and abnormal gait patterns.\n\nThese impairments reduce functional independence and increase caregiver burden. Loaded Treadmill Training and Task Specific Training are two rehabilitation approaches used to improve strength and Gait function.\n\nThis study compares their effectiveness in improving gait and functional mobility in children with spastic diplegic CP.', 'detailedDescription': 'Cerebral Palsy (CP) is the most common non-progressive neurological disorder of childhood, resulting from injury to the developing brain. It is characterized by impaired posture, abnormal movement patterns, and increased muscle tone. Globally, CP affects 2-3.5 per 1000 live births, with an estimated prevalence of 2.5 per 1000 live births in Pakistan. Major risk factors include prematurity, low birth weight, multiple gestations, neonatal jaundice, fetal trauma, hypoxic brain injury, and exposure to toxic substances. Spastic CP is the most common type, frequently affecting the lower limbs. Spasticity, defined as velocity-dependent increase in muscle tone, interferes with voluntary control and increases energy expenditure, leading to muscle weakness, contractures, and skeletal deformities. It results from impaired regulation of motor pathways, particularly corticospinal, reticulospinal, and vestibulospinal tracts. In children with spastic diplegia, altered neural signaling affects muscle growth and morphology, reducing muscle volume, length, and strength. Studies report a 18-50% reduction in muscle size, contributing significantly to muscle weakness around the knee and ankle joints. Spastic diplegia primarily affects the lower extremities, producing gait abnormalities such as toe walking, crouch gait, scissoring, persistent knee flexion, reduced dorsiflexion, decreased stride length, slower walking velocity, and prolonged double limb support. These impairments limit functional independence, restrict participation in daily activities, and reduce quality of life, while also increasing caregiver burden. Improving gait is therefore a major goal of pediatric rehabilitation. Strengthening of lower limb muscles has shown a positive relationship with ambulatory function. Loaded Treadmill Training (LTT) is a resisted strength training approach in which external loads (e.g., ankle weights) are applied during treadmill walking to enhance muscle effort, motor learning, sensory feedback, and walking performance. Resistance is progressively increased, typically around 60% of lower limb weight, according to tolerance. Task-Specific Training (TST) is based on principles of neuroplasticity and motor learning. It involves repetitive practice of functional tasks such as standing, walking, and balance activities in real-life environments. TST enhances muscle strength, coordination, balance, and participation by progressively increasing task difficulty. Two scales are used, Gross Motor Function Measure -88; The interrater and intra-rater reliability of the GMFM-88 total score, assessed with the intra-class correlation coefficient (ICC), are both 0.99. Validity was confirmed by a correlation of 0.82, Jakes Analysis; Observational gait analysis has high validity of 0.94. Inter observer reliability is moderately high and is 0.76 while the intra observer reliability is also high that is 0.89. Both interventions are commonly combined with routine physiotherapy and neurodevelopmental treatment (NDT) approaches to improve motor control. Although both LTT and TST demonstrate beneficial effects on gait and functional mobility in children with spastic diplegic CP, there is limited evidence directly comparing their effectiveness. Therefore, this study aims to determine and compare the effects of Loaded Treadmill Training and Task-Specific Training on gait parameters and functional mobility in children with spastic diplegic cerebral palsy, with the goal of enhancing independence and reducing caregiver burden.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of Spastic Diplegic Cerebral Palsy\n* 6 to 12 years\n* Gross Motor Function Classification System Level I to III\n* Stand independently or with support\n\nExclusion Criteria:\n\n* Diagnosed with any type other then Spastic Diplegic\n* Presence of Comorbidities\n* Severe Cognitive and Communicative impairments\n* Classified as Gross Motor Function Classification System Level IV and V'}, 'identificationModule': {'nctId': 'NCT07474818', 'acronym': 'ELTTS-GFM-SDCP', 'briefTitle': 'Loaded and Task Specific Training in Spastic Diaplegic CP to Improve Gait and Functional Mobility.', 'organization': {'class': 'OTHER', 'fullName': 'Lahore University of Biological and Applied Sciences'}, 'officialTitle': 'Effects of Loaded Treadmill and Task Specific Training on Gait and Functional Mobility in Children With Spastic Diplegic Cerebral Palsy', 'orgStudyIdInfo': {'id': 'DPT/ERB/34'}, 'secondaryIdInfos': [{'id': 'U1111-1335-7052', 'type': 'REGISTRY', 'domain': 'Laiba Nadeem'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Loaded Treadmil Training + Conventional Therapy', 'description': "Participants in the intervention will receive Loaded Treadmill Training for 40 minutes, 3 times per week, for 6 weeks. The session consists of three bouts of treadmill training with two 5-minute breaks. The treadmill's walking speed will be increased gradually. Additionally, conventional therapy will be given for 40 minutes 3 times per week, for 6 weeks", 'interventionNames': ['Device: Loaded Treadmill Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Task-Specific Training + Conventional Therapy', 'description': 'Participants in this arm will receive Task-Specific Training (TST) for 40 minutes per session, 3 times per week, for 6 weeks.\n\nThe sessions will include a 5-minute warm-up, 30 minutes of functional activities (progressing in difficulty every two weeks), and a 5-minute cool-down.\n\nAdditionally, participants will receive 40 minutes of Conventional Physical Therapy per session, 3 times per week for 6 weeks.', 'interventionNames': ['Other: Task specific Training']}], 'interventions': [{'name': 'Loaded Treadmill Training', 'type': 'DEVICE', 'description': 'loaded treadmill training is a gait rehabilitation approach in which children walk on a treadmill while external loads (such as ankle weights) are applied to the lower limbs. The load is gradually increased to enhance muscle strength, motor learning, and walking performance. This intervention helps improve stride length, cadence, gait velocity, and overall functional mobility in children with spastic diplegic cerebral palsy.', 'armGroupLabels': ['Loaded Treadmil Training + Conventional Therapy']}, {'name': 'Task specific Training', 'type': 'OTHER', 'description': 'Task-specific training is a rehabilitation approach based on repetitive practice of functional activities. Children perform tasks such as standing, walking, stepping, and balance activities in a structured therapy program. This approach aims to enhance coordination, strength, motor control, and functional mobility in children with spastic diplegic cerebral palsy.', 'armGroupLabels': ['Task-Specific Training + Conventional Therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Lahore University of Biological Applied Health Sciences', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'Misha Zahid Zahid, Doctor of Physicall Therapy', 'role': 'CONTACT', 'email': 'misha.zahid@ubas.edu.pk', 'phone': '03277866777'}], 'overallOfficials': [{'name': 'Najam Zia Zia ul Haq, Doctor of Physical therapy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lahore College of physical therapy'}, {'name': 'Laiba Nadeem Nadeem, Doctor of Physical Therapy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lahore College of Physical Therapy'}, {'name': 'Ayesha Fatima, Doctor of Physical Therapy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lahore College of physical therapy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lahore University of Biological and Applied Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Demonstrator Study chair', 'investigatorFullName': 'Dr. Misha Zahid', 'investigatorAffiliation': 'Lahore University of Biological and Applied Sciences'}}}}