Effect of Treadmill Gait Training Combined With Conventional Physiotherapy on Gait Performance and Functional Mobility in Children With Bilateral Spastic Cerebral Palsy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
Cerebral palsy is a neurological condition that affects movement, muscle control, and walking ability in children. Children with bilateral spastic cerebral palsy often experience increased muscle stiffness, difficulty with walking, reduced balance, and limited functional mobility. This randomized controlled trial aims to evaluate whether treadmill gait training combined with conventional physiotherapy can improve walking ability, gross motor function, balance, and mobility compared with conventional physiotherapy alone. Children with bilateral spastic cerebral palsy will receive a 12-week rehabilitation program, and changes in motor function, gait performance, spasticity, and walking endurance will be assessed before and after treatment.
详细描述
Bilateral spastic cerebral palsy (CP) is associated with lower-limb spasticity, impaired motor control, abnormal gait patterns, reduced walking speed, and limitations in functional mobility. Task-specific repetitive locomotor training is an important component of pediatric neurorehabilitation, and treadmill gait training may enhance stepping practice and improve gait-related outcomes.
This assessor-blinded, parallel-group randomized controlled trial aims to evaluate the effect of treadmill gait training combined with conventional physiotherapy compared with conventional physiotherapy alone in children with bilateral spastic CP. Children aged 6-16 years with GMFCS Level I-III will be recruited from Syeda Khatoon e Jannat Trust Hospital.
Participants will be randomly allocated into two groups. The intervention group will receive treadmill gait training (30 minutes/session, 3 sessions/week for 12 weeks) in addition to conventional physiotherapy, including stretching, strengthening, balance training, and functional activities. The control group will receive conventional physiotherapy alone.
Outcomes will be assessed at baseline and after intervention using the Gross Motor Function Measure (GMFM-66) as the primary outcome, along with the 10 Meter Walk Test, Timed Up and Go Test, Pediatric Balance Scale, Modified Ashworth Scale, and 6 Minute Walk Test to evaluate gait performance, functional mobility, balance, spasticity, and walking endurance.
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)
盲法说明
Outcome assessors will be blinded to group allocation to reduce measurement bias. Participants and care providers will not be blinded due to the nature of the rehabilitation intervention.
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically confirmed diagnosis of bilateral spastic cerebral palsy.
- •Aged 6 to 16 years.
- •Classified as GMFCS Levels I-III.
- •Able to stand independently, with or without support.
- •Presence of clinically significant lower-limb spasticity, defined as Modified Ashworth Scale (MAS) score ≥
- •Demonstrated ambulatory ability with Timed Up and Go (TUG) ≤10 seconds.
- •Demonstrated walking ability with 6-Minute Walk Test (6MWT) distance of 50-500 meters at baseline.
- •Able to understand simple verbal commands and participate in structured therapy sessions.
- •Parent or legal guardian willing to provide written informed consent.
- •Willing and able to attend the complete 12-week intervention protocol.
排除标准
- •Botulinum toxin injection within the previous 6 months.
- •Recent pharmacological intervention significantly affecting spasticity.
- •Lower-limb orthopedic surgery within the previous 12 months.
- •Severe intellectual disability (IQ <70) or inability to follow simple instructions required for therapy participation.
- •Uncontrolled seizures, epilepsy, or other neurological conditions that could interfere with participation.
- •Fixed musculoskeletal contractures limiting standing, stepping, or gait training.
- •Cardiopulmonary, medical, or orthopedic conditions that contraindicate treadmill-based exercise.
- •Current participation in another gait-training or rehabilitation research study.
研究组 & 干预措施
Treadmill Gait Training + Conventional Physiotherapy
Participants will receive treadmill gait training combined with conventional physiotherapy for 12 weeks. Treadmill training will be provided for 30 minutes per session, 3 sessions per week (total 36 sessions). Treadmill speed, assistance level, and progression will be individually adjusted according to participant tolerance, gait quality, and safety. Sessions will be supervised by a qualified physiotherapist.
The conventional physiotherapy program will include stretching exercises, strengthening exercises, balance training, and functional task-oriented activities including sit-to-stand practice, stair training, and obstacle negotiation.
干预措施: Treadmill Gait Training (Other)
Treadmill Gait Training + Conventional Physiotherapy
Participants will receive treadmill gait training combined with conventional physiotherapy for 12 weeks. Treadmill training will be provided for 30 minutes per session, 3 sessions per week (total 36 sessions). Treadmill speed, assistance level, and progression will be individually adjusted according to participant tolerance, gait quality, and safety. Sessions will be supervised by a qualified physiotherapist.
The conventional physiotherapy program will include stretching exercises, strengthening exercises, balance training, and functional task-oriented activities including sit-to-stand practice, stair training, and obstacle negotiation.
干预措施: Conventional Physiotherapy (Other)
Conventional Physiotherapy
Participants will receive conventional physiotherapy for 12 weeks, 3 sessions per week. The rehabilitation program will include stretching exercises, strengthening exercises, balance training, and functional task-oriented activities. The intervention will follow the same duration and frequency as the experimental group but without treadmill gait training.
干预措施: Conventional Physiotherapy (Other)
结局指标
主要结局
Pain intensity
时间窗: Baseline, 6 weeks and 12 weeks (60 treatment sessions)
Pain intensity was measured using the Visual Analogue Scale (VAS), a 100-mm horizontal line anchored with "no pain" and "worst imaginable pain." Participants marked their perceived pain intensity, and scores were recorded in millimetres (0-100 mm), where higher scores indicate greater pain intensity.
Change in Gross Motor Function Measure-66 (GMFM-66) Score
时间窗: Baseline and Week 12
The Gross Motor Function Measure-66 (GMFM-66) is a standardized and validated observational assessment used to evaluate changes in gross motor function in children with cerebral palsy. This study will assess changes in the Standing (Dimension D) and Walking, Running, and Jumping (Dimension E) domains to evaluate improvements in functional mobility and gait-related abilities.
次要结局
- Neuropathic pain assessment(Baseline, 6 weeks and 12 weeks)
- Neuropathic pain and sensory function(Baseline, 6 weeks and 12 weeks)
- MAS(Baseline and Week 12)
- Change in 10 Meter Walk Test (10MWT) Walking Velocity(Baseline and Week 12)
- Change in Timed Up and Go Test (TUG) Performance(Baseline and Week 12)
- Change in Pediatric Balance Scale (PBS) Score(Baseline and Week 12)
- Change in Modified Ashworth Scale (MAS) Score(Baseline and Week 12)
- Change in 6 Minute Walk Test (6MWT) Distance(Baseline and Week 12)
研究者
Dr. Tehreem Jameel
Principal Investigator and Clinical Research Coordinator
Syeda Khatoon e Jannat Welfare Foundation