Effects of High-Velocity Passive Stretching Protocol on Spasticity, Functional Status, and Muscle Architecture in Children With Spastic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Fascicle length measured via ultrasound in maximum dorsiflexion and resting positions.
研究概览
简要总结
One of the traditional exercises applied to cerebral palsy (CP) is passive stretching exercises. Passive stretching exercises can be applied to these patients at various speeds. A recent study has shown that high-speed passive stretching in children with CP can increase muscle bundle length in spastic muscles. Therefore, high-speed stretching exercises may potentiate the positive effects of BoNT-A treatment on spasticity and muscle fascicle in patients with CP.
This study aims to investigate whether fast stretching exercises administered to children with CP following BoNT-A injection are more effective than standard stretching in improving spasticity, functional status, and muscle architecture.
详细描述
Cerebral palsy (CP) is characterized as a neurodevelopmental disorder resulting in enduring deficits in mobility and posture owing to non-progressive injury to the infant or developing brain. CP is the predominant etiology of physical impairment observed in children. Research indicates a global prevalence of 1.6 per 1,000 live births in developing nations and 3.4 per 1,000 in low- and middle-income countries. Ninety percent of all CP patients demonstrate spasticity as a symptom. Spasticity is characterized by a speed-dependent augmentation of excessive stretch reflexes, stemming from the hyperexcitability of these reflexes due to upper motor neuron injury. Management of spasticity includes physical therapy techniques, antispasmodic medication, botulinum toxin administration, orthotic devices, therapeutic exercises, and surgical interventions. Stretching exercises constitute one of the initial therapeutic interventions and have been employed for numerous years. Certain studies indicate that the impact of conventional stretching on joint range of motion and spasticity is constrained. If spasticity is not appropriately managed, it may hinder motor learning and the development of movement abilities, leading to various functional impairments such as joint contractures and gait issues over time, while also causing changes in muscle architecture. Muscle architecture denotes the configuration of fibers or fascicle bundles within the muscle. It encompasses the fascicle length and pennation angle.
The length of a muscle fiber or fascicle correlates with the muscle's maximal excursion and contraction velocity, reflecting the number of sarcomeres arranged in series. The physiological cross-sectional size of a muscle is directly related to its maximum force production capability and the quantity of sarcomeres arranged in parallel. Numerous investigations have documented a reduction in fascicle length in the afflicted limbs of children with cerebral palsy. The extension of fascicle length can beneficially impact children's functional capabilities by improving the muscle's length-tension and force-velocity properties. Consequently, the extension of fascicle length is crucial for enhancing children's motor functions and functional capabilities. Ultrasonography of the musculoskeletal system serves as a potential instrument for assessing alterations in in vivo muscle architecture. It has been utilized in numerous research studies, including the pediatric population, to elucidate muscle anatomy. One study indicated that high-speed passive stretching may enhance muscle fascicle length in spastic muscles.
The hypothesis of the study is that rapid stretching exercises administered to children with cerebral palsy who have undergone BoNT-A treatment will yield superior outcomes in spasticity, functional status, and muscle architecture compared to conventional speed stretching.
Method:
Study Design and Participants:
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 2 to 8 years diagnosed with cerebral palsy of the hemiplegic or diplegic type according to the Rosenbaum criteria
- •Presence of spasticity in the ankle plantar flexors with a Modified Ashworth Scale (MAS) score of 1, 1+, 2, or 3, and a clinical indication for BoNT-A injection into the gastrocnemius or gastrocnemius/soleus muscles at this stage of treatment
- •Gross Motor Function Classification System (GMFCS) levels of 1, 2, or 3 (ambulatory)
排除标准
- •Having a neuromuscular disorder other than cerebral palsy
- •Presence of a fixed foot deformity
- •Receiving serial casting or spasticity treatments (e.g., baclofen or BoNT-A) within the past 6 months
- •History of surgery
- •Having intellectual or behavioral difficulties, or comorbid conditions (such as cardiac, respiratory disorders or uncontrolled seizures) that prevent safe participation in exercise
结局指标
主要结局
Fascicle length measured via ultrasound in maximum dorsiflexion and resting positions.
时间窗: Patients will be assessed at the hospital before the BoNT-A injection and at the 1st, 3rd, and 6th months following the injection
The patient will be positioned prone with the ankle hanging freely off the edge of the examination table. Imaging will be performed over the medial gastrocnemius in full knee extension (0° flexion) during both maximum dorsiflexion (MDF) and resting positions. Using two-dimensional ultrasound, the length of the longest fascicle extending between the superficial and deep fascia will be measured at the thickest point of the medial gastrocnemius muscle.
次要结局
- Pennation angle(Patients will be assessed at the hospital before the BoNT-A injection and at the 1st, 3rd, and 6th months following the injection)
- Gastrocnemius muscle thickness(Patients will be assessed at the hospital before the BoNT-A injection and at the 1st, 3rd, and 6th months following the injection)
- Assessment of Spasticity (Modifiye ashworth classification)(Patients will be assessed at the hospital before the BoNT-A injection and at the 1st, 3rd, and 6th months following the injection)
- Assessment of Spasticity (Tardie Scale)(Patients will be assessed at the hospital before the BoNT-A injection and at the 1st, 3rd, and 6th months following the injection)
- Range of Motion(Patients will be assessed at the hospital before the BoNT-A injection and at the 1st, 3rd, and 6th months following the injection)
- Observational Gait Analysis(Patients will be assessed at the hospital before the BoNT-A injection and at the 1st, 3rd, and 6th months following the injection)
- The Gross Motor Function Measure-66(Patients were assessed at the hospital before the BoNT-A injection and at the 1st, 3rd, and 6th months after the injection.)
研究者
İsa Cüce
Associate Professor
TC Erciyes University