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Not yet recruiting NCT07474818

Loaded and Task Specific Training in Spastic Diaplegic CP to Improve Gait and Functional Mobility.

No phase Interventional Spastic Diplegia Cerebral Palsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Loaded Treadmill Training, Task specific Training.
Who it may be relevant to
Registry conditions: Spastic Diplegia Cerebral Palsy. Basic parameters: 6 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Loaded Treadmill and Task Specific Training on Gait and Functional Mobility in Children With Spastic Diplegic Cerebral Palsy

Overview

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.

Detailed description

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.

Interventions

  • Device Loaded Treadmill Training
    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.
  • Other Task specific Training
    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.

Primary outcome measures

  • Change in Gait Parameter: Cadence [Time frame: Baseline and after 6 weeks]
  • Change in Gait Parameter: Velocity [Time frame: Baseline and 6 weeks]
  • Change in Gait Parameter: Stride Length [Time frame: Baseline and after 6 weeks]
  • Change in Functional Mobility [Time frame: Baseline and after 6 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Lahore University of Biological Applied Health Sciences — Lahore

Identifiers

NCT: NCT07474818 · DPT/ERB/34 · U1111-1335-7052

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗