Effects of Botulinum Toxin A on Selective Motor Control in Cerebral Palsy: A Simultaneous Assessment of Upper and Lower Extremities
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- SCALE (Selective Control Assessment of the Lower Extremity)
研究概览
简要总结
The aim of this study is to investigate the effects of Botulinum Neurotoxin-A (BoNT-A) injection applied to spastic muscles on pain sensation and Selective Motor Control (SMC) in cases diagnosed with diplegic spastic Cerebral Palsy.
详细描述
Cerebral Palsy (CP) is a non-progressive, permanent neurological disorder that occurs in the fetal or infant brain. CP, defined as a group of non-progressive movement and posture disorders, is the most common cause of neurological disability in children. The primary cause is insufficient oxygen supply to the fetus and brain asphyxia. However, other underlying factors may also be involved. Preterm birth is the most important risk factor that should be considered first.
Musculoskeletal problems mainly arise due to positive findings such as spasticity, clonus, hyperreflexia related to Upper Motor Neuron damage, and negative findings such as weakness and reduced Selective Motor Control (SMC).
Selective Motor Control (SMC) is the ability to achieve muscle activation in an appropriate pattern, in an isolated manner, to produce a voluntary movement or posture. Studies have shown that the impact of SMC on motor performance is as significant as routinely measured issues such as spasticity and contracture.
Pain is a common problem in CP, with more than half of children and adults with CP reporting pain as an issue. Assessing pain in children with CP is particularly challenging, especially in those who cannot express themselves verbally. The most common potential causes of pain include neuromuscular problems such as muscle spasms, musculoskeletal problems like hip dislocation and scoliosis, and gastrointestinal issues such as gastroesophageal reflux and constipation.
Botulinum Neurotoxin-A (BoNT-A), when applied intramuscularly, inhibits presynaptic acetylcholine (Ach) release by preventing the fusion of Ach vesicles with the plasma membrane. BoNT-A acts on the motor endplate, providing reversible chemical denervation. It is used for localized spasticity and can be applied to multiple muscles in a single session. It is generally used for spasticity starting from the age of 2. Along with rehabilitation, it aids in motor learning, promotes functional progression, and delays or prevents the development of orthopedic deformities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Cerebral Palsy
- •Between the ages of 4-12
- •GMFCS (Gross Motor Function Classification System)1-4
- •Patients who have received an appropriate indication for BoNT-A injection from an experienced physiatrist
- •Patients who have not had botulinum toxin administered in the last 6 months
排除标准
- •Mental retardation
- •Have an intrathecal baclofen pump for spasticity treatment or history of soft tissue and/or bone surgery
- •Underwent dorsal rhizotomy
- •Have an active infection or a localized skin infection at the injection site
- •Using aminoglycoside antibiotics
- •Contracture
研究组 & 干预措施
Conventional Physical Therapy Group
Conventional rehabilitation, personalized and administered under the guidance of a physiotherapist
干预措施: Conventional Physical Therapy (Other)
Botulinum toxin injection group
Administration of botulinum toxin injection prior to the conventional rehabilitation program
干预措施: Conventional Physical Therapy (Other)
Botulinum toxin injection group
Administration of botulinum toxin injection prior to the conventional rehabilitation program
干预措施: OnabotulinumtoxinA (Drug)
结局指标
主要结局
SCALE (Selective Control Assessment of the Lower Extremity)
时间窗: six weeks
SCALE; it is a scale that can be easily applied in outpatient clinic conditions, does not require any equipment. A total of 5 regions are assessed: the hip, knee, ankle, subtalar joint, and toes. Scoring is as follows: 0 (cannot be performed), 1 (impaired SMC), and 2 (normal). If the patient performs the movement correctly within 3 seconds, without moving any other joint besides the one being evaluated and without any mirror movement, it is considered normal SMC (2 points). If there is movement in another joint, mirror movement occurs, the range of motion is less than 50% of the passive ROM (Range Of Motion), or the movement takes longer than 3 seconds, it is considered impaired SMC (1 point). If the patient cannot initiate the movement or develops flexor/extensor synergy, it is scored as unachievable (0 points).
Boyd and Graham SMC Test
时间窗: six weeks
This test, developed by Boyd and Graham, aims to evaluate the Selective Motor Control (SMC) of ankle dorsiflexion. The test assesses the patient's ability to activate the muscles responsible for ankle dorsiflexion (DF). It consists of 5 items and is scored on a scale from 0 to 4. 0: No movement at all when asked to dorsiflexion the foot. 1. Limited dorsiflexion achieved primarily through the use of extensor hallucis longus (EHL) and/or extensor digitorum brevis (EDB). 2. Limited dorsiflexion achieved using EHL, EDB, and some tibialis anterior (TA) muscle. 3. Dorsiflexion primarily using TA, but with accompanying hip and knee flexion. 4. Isolated selective ankle dorsiflexion (DF) achieved through isolated TA muscle activity without hip or knee flexion.
Visual Analog Scale (VAS)
时间窗: six weeks
The Visual Analog Scale (VAS) is a very simple and easy-to-use pain scale where patients assess the intensity of their pain between "no pain" (0 points) and "unbearable pain" (10 points). The patient rates their pain on a scale from 0 to 10: 0: No pain 1-3: Mild pain 4-6: Moderate pain 7-10: Severe pain
次要结局
- SCUES (Selective Control of the Upper Extremity Scale)(six weeks)
- Functional Independence Measure for Children (WeeFIM)(six weeks)
- Pediatric Quality of Life Inventory (PedsQL)(six weeks)
- Child and Adolescent Participation Questionnaire (CASP)(six weeks)