A Pilot Study of the Effect of Botulinum Toxin Type a (Dysport®, Abobotulinum Toxin A) Injection on Changes in Musculotendinous Length and Dynamics of Hamstring Muscles During Gait in Children With Spastic Cerebral Palsy Walking With Excessive Knee Flexion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Changes in musculotendinous length of hamstrings
研究概览
简要总结
This is a longitudinal, prospective, and open-label interventional study in a single center. We will investigate the effect of single injection in each patient. This study was designed to establish the clinical evidence for effect of botulinum toxin type a (Dysport, abobotulinum toxin A) injection on changes in musculotendinous length and dynamics of hamstring muscles during gait in children with spastic cerebral palsy walking with excessive knee flexion.
Baseline data such as Modified Ashworth scale (MAS), Modified Tardieu scale (MTS), Gross Motor Function Measures (GMFM), and Gross Motor Function Classification System (GMFCS) level will be assessed. Gait analysis will be performed using a computerized gait analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the gait cycle. A trained investigator will place 14 reflective markers on the anterior and posterior superior iliac spine, the mid points of the lateral femur, the lateral knee joint axis, the midpoints of the lateral tibia, the lateral malleolus, and the dorsal foot between metatarsal heads 2 and 3. All subjects should walk barefoot at a self-selected speed along an 8-meter path with the markers in place and the motion will be captured with a 100-Hz sampling frequency. Force-plates (AMTI OR 6-5, Advanced Mechanical Technology, Newton, MA, USA) under the path will record ground reaction forces during the walking trials with a 1000-Hz sampling frequency, and joint moments will be expressed as internal moments to counter the ground reaction forces. Data collection will continue until the subject achieved at least 3 'clean' force-plate strikes. Kinematic and kinetic data from successful trials will be used for statistical analysis. Video recording will be done simultaneously from the front, rear, and side, with the 3D gait analysis.
详细描述
Based on the evaluation including gait analysis, we will select the target muscles and inject the toxin into the selected muscles of the spastic lower limb under the guidance of ultrasonography or electrical stimulation. After BoNT-A injection, these children will be evaluated after 1 month. Clinical data obtained in the baseline measurement will be assessed again. Motion capture data will also be collected. Finally, clinical data of patients will be collected 4 months after injection to identify the clinical improvement and side effects.
Motion capture data will be imported to OpenSim. We will generate an inverse kinematic analysis of each subject using following procedure:
- Scale the model to match the anthropometry of each subject. We will scale the dimensions of the torso, pelvis, thigh, shank, and foot based on the relative distances between pairs of markers measured experimentally and the corresponding markers in the model. The muscle attachments will also be scaled with the segment.
- Using a least-squares formulation, a set of desired joint angles for tracking, consistent with each scaled model, based on the marker trajectories, joint constraints, and joint angles from gait analysis will be computed.
- The musculotendinous length of each muscle will be calculated based on the "lower limb model 2010" by Arnold. This model adopted the wrapping surface to calculate the moment arm and musculotendinous unit passage at each joint. This model is intended to be used in research-graded kinematic analysis.
- Objectives <Primary objective>
1.To determine the changes of musculotendinous length of hamstrings after a single BoNT-A injection during walking in children with spastic CP walking with excessive knee flexion <Secondary objectives>
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with CP over the age of 2 years
- •The spasticity is thought to interfere motor learning or cause abnormal posture and movement patterns by "management algorithm" of international consensus.
- •MAS ≥ 1+ at hamstrings
- •Dynamic spasticity rather than fixed contracture: Difference between Xv1 and Xv3 is at least 15 degrees in MTS at hamstrings
- •I to III levels of GMFCS
排除标准
- •Children who received interventions such as chemical nerve block or casting within 6 months
- •Children who had baclofen pump
- •Children who experienced the adverse reactions from previous BoNT-A injections
- •Children who have a mixed type of CP (Athetosis, dystonia) or other movement disorder (eg. ataxia)
- •Children who are participating in other investigational study at the moment
- •Children who are not suitable for this study according to the investigator's discretion
研究组 & 干预措施
BTX injection group
Botulinum toxin injection group
干预措施: Botulinum toxin injection (Drug)
结局指标
主要结局
Changes in musculotendinous length of hamstrings
时间窗: 16 weeks after intervention
Changes in musculotendinous length of hamstrings obtained from 3D motion analysis after a single BoNT-A injection during walking in children with spastic CP walking with excessive knee flexion
次要结局
未报告次要终点