Effects of Loaded Treadmill and Task Specific Training on Gait and Functional Mobility in Children With Spastic Diplegic Cerebral Palsy
| Registry | NCT07474818, acronym ELTTS-GFM-SDCP |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 54 (Estimated) |
| Sponsor | Lahore University of Biological and Applied Sciences (Other) |
| Conditions | Spastic Diplegia Cerebral Palsy |
| Interventions | Loaded Treadmill Training, Task specific Training (Device, other) |
| Dates | start 2026-04-01 (estimated), primary completion 2026-04-23 (estimated), completion 2026-07-31 (estimated), first posted 2026-03-16, last updated 2026-03-17 |
| Locations | 1 site in Pakistan |
Related Papers Related Patents Related Grants Related Experts
All trials for Spastic Diplegia Cerebral Palsy All trials of Loaded Treadmill Training All trials of Task specific Training
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.
These 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.
This study compares their effectiveness in improving gait and functional mobility in children with spastic diplegic CP.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Loaded Treadmil Training + Conventional Therapy | Experimental | Device: Loaded Treadmill Training | 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 |
| Task-Specific Training + Conventional Therapy | Active comparator | Other: Task specific Training | Participants in this arm will receive Task-Specific Training (TST) for 40 minutes per session, 3 times per week, for 6 weeks. The 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. Additionally, participants will receive 40 minutes of Conventional Physical Therapy per session, 3 times per week for 6 weeks. |
Sex: All, ages: 6 Years to 12 Years
Inclusion Criteria: * Confirmed diagnosis of Spastic Diplegic Cerebral Palsy * 6 to 12 years * Gross Motor Function Classification System Level I to III * Stand independently or with support Exclusion Criteria: * Diagnosed with any type other then Spastic Diplegic * Presence of Comorbidities * Severe Cognitive and Communicative impairments * Classified as Gross Motor Function Classification System Level IV and V
| Facility | City | Country | Status |
|---|---|---|---|
| Lahore University of Biological Applied Health Sciences | Lahore, Punjab Province | Pakistan |