Effect of Neural Mobilization, Compared to Conventional Physical Therapy, in Children Diagnosed With Cerebral Palsy. A Pragmatic Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Range of motion
研究概览
简要总结
Objective: To assess the effect of neural mobilization applied to the lower limbs, compared to conventional physical therapy, in children diagnosed with Cerebral Palsy. Using the International Classification of Functioning, Disability and Health, the investigators will try to evaluate the impact of the intervention in aspects related with structure, activity, and participation.This project will mainly focus on the structure dimension. More specifically, the investigators aim to observe if a treatment protocol designed to modify the structure (e.g.,the sciatic nerve using neural mobilization techniques), will evoke changes not only in the structural dimension, but also will be able to modify the activity and participation dimensions.
Design: A single blinded randomized clinical trial (the evaluator will remain blinded to treatment allocation group) will be conducted. The experimental group will receive an intervention consisting on the use of neurodynamic mobilization procedures of the lower limb and participants in the control group will undergo a conventional physical therapy intervention (stretching, mobilization), without the use of neural mobilization.
Subjects: Participants will be aged between 5 and 18 years, and with a confirmed diagnosed of Cerebral Palsy with the presence of spasticity in the lower limbs.
Methods: Participants will be randomly allocated into two groups: experimental or control group. The primary outcome will be the range of motion (flexion and extension) of the hip, knee and ankle. Secondary outcomes will include gross motor function, pain intensity, muscle stiffness, muscle tension, and functional measures.
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
Sealed opaque envelopes will be used for treatment allocation. The research in charge of collecting the outcome measures will remained unaware of treatment allocation group
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents diagnosed with Cerebral Palsy or presence of spasticity and aged between 5 and 18 years.
- •Level I to IV in the Gross Motor Function Classification System, which denotes that the participant should be able to walk with or without using assistive devices.
- •Increased muscle tone in the lower extremities, represented by a score greater than 0 on the Tardieu clinical scale and a positive response in the Duncan Ely test.
- •Ability to communicate pain.
- •Ability to follow simple commands.
排除标准
- •Have ankle joint arthrodesis or any surgical operation that prevents joint mobilization of the lower limb to some degree.
- •Any significant change in medication treatment during the study period that may influence (increase or decrease) muscle tone.
- •Experience uncontrolled epileptic seizures despite medication.
- •Have received botulinum toxin treatment in the lower limb within the 3 months prior to the study.
- •Undergo a different physical therapy treatment parallel to that developed in the study.
研究组 & 干预措施
Neural mobilization of the lower limb
Several neural mobilization techniques will be performed for the lower limb, with a special focus on the sciatic nerve. First, three different passive techniques will be used. These will consist of two sets of ten repetitions each with one minute rest between sets. This will last approximately 5 minutes. Then, three dynamic neural mobilization techniques will be performed, with each exercise lasting for 5 minutes per set, including two different sets (one minute rest between them), with a total of 10 minutes of mobilization and one minute of rest per exercise. Therefore the complete approach will last for 30 minutes approximately. Following this set of dynamic neural mobilization exercises, static neural mobilizations of the sciatic nerve will be performed again following the same order and duration than in the beginning.
干预措施: Neural mobilization of the lower limb (Procedure)
Conventional physiotherapy treatment
A conventional treatment will be performed, consisting of passive and active mobilizations, active stretching, and techniques aimed at improving daily life activities
干预措施: Conventional physical therapy (Procedure)
结局指标
主要结局
Range of motion
时间窗: From baseline to up to 8 weeks, with a 3-month and a 6-month follow up
Passive range of motion will be assessed for flexion and extension of the hip, knee, and ankle. Using a handheld goniometer, each joint will be measured three times, using the average of the three measures for subsequent analysis.
次要结局
- Self-reported pain intensity(From Baseline to up to 8 weeks, with a 3-month and a 6- month follow up)
- Activity and Participation(From Baseline to up to 8 weeks.,with a 3-month and a 6- month follow up)
- Spasticity(From Baseline to up to 8 weeks, with a 3-month and a 6- month follow up)
- Myotonometry(From Baseline to up to 8 weeks, with a 3-month and a 6- month follow up)
- Health-related quality of life(From Baseline to up to 8 weeks, with a 3-month and a 6- month follow up)
研究者
Alberto Marcos Heredia-Rizo
University Full Professor
University of Seville