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临床试验/NCT07474818
NCT07474818尚未招募不适用

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

Lahore University of Biological and Applied Sciences1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2026年4月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
54
试验地点
1
主要终点
Change in Gait Parameter: Cadence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Loaded Treadmil Training + Conventional Therapy

Experimental

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

干预措施: Loaded Treadmill Training (Device)

Task-Specific Training + Conventional Therapy

Active Comparator

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.

干预措施: Task specific Training (Other)

结局指标

主要结局

Change in Gait Parameter: Cadence

时间窗: Baseline and after 6 weeks

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.

Change in Gait Parameter: Velocity

时间窗: Baseline and 6 weeks

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.

Change in Gait Parameter: Stride Length

时间窗: Baseline and after 6 weeks

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.

Change in Functional Mobility

时间窗: Baseline and after 6 weeks

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.

次要结局

未报告次要终点

研究者

发起方
Lahore University of Biological and Applied Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Misha Zahid

Demonstrator Study chair

Lahore University of Biological and Applied Sciences

研究点 (1)

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