Algorithms for Patient-specific Treatment Planning in Cerebral Palsy Based on the Muscle and Tendon Architecture - Short Term Follow-up of a Botulinum Toxin Intervention in Children With Spastic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Change in Gait Profile Score (Degrees)
研究概览
简要总结
This study investigates the effect of integrated Botulinum Neurotoxin A (BoNT) treatment on morphologic muscle and tendon properties, spasticity, joint stiffness, joint range of motion, muscle strength, gait and gross motor function. The integrated BoNT treatment combines BoNT-injections with serial casting and intensive physical therapy, as previously described by Molenaers et al. The current study will include 30 children who are clinically scheduled for BoNT treatment in the medial gastrocnemius and/or the semitendinosus muscle in the intervention group and 30 children in a control group who will receive usual care within a time span of 3 months.
详细描述
Aim:
This study investigates the effect of integrated Botulinum Neurotoxin A (BoNT) treatment on morphologic muscle and tendon properties (muscle length and muscle volume, assessed with a 3D ultrasound measurement), spasticity and joint stiffness (measured with an instrumented spasticity assessment), joint range of motion (measured through goniometry), muscle strength (measured using dynamometry), gait (assessed through 3D gait analysis) and gross motor function (assessed using clinical test batteries). The aim is twofold: (1) determine whether integrated BoNT treatment of the medial gastrocnemius and the semitendinosus muscle(s) leads to changes in the morphologic muscle and tendon properties of the medial gastrocnemius and the semitendinosus muscle(s), the ankle and knee range of motion, spasticity, stiffness, muscle strength and gait, and (2) determine the correlation between baseline morphologic muscle and tendon properties and the changes in the primary outcome parameters (spasticity and stiffness) following the BoNT-treatment.
Design:
The current study has a non-randomized controlled design. Because BoNT is proven an effective treatment to reduce spasticity and improve gross motor function, it cannot be clinically justified to allocate children to a non-treatment group, if a new BoNT treatment is required. Delayed BoNT treatment could rapidly increase musculoskeletal impairments. It is therefore considered unethical to temporarily withdraw BoNT treatment from patients. To compensate the lack of randomization accurate matching of groups is required. Children will be matched on diagnosis (uni/bilateral CP), GMFCS level, age and spasticity level.
BoNT-treatment:
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 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of spastic cerebral palsy
- •Aged 4-11 years
- •GMFCS levels I-III (GMFCS = Gross Motor Function Classification Score, expressing the overall functional level of impairment)
- •Sufficient cooperation to comprehend and complete the test procedure
- •Additional exclusion criterion for the intervention group specifically: Indication for BoNT injections
排除标准
- •Non-ambulatory
- •Botulinum toxin A injections six months prior to enrollment
- •Lower limb surgery two years prior to enrollment
- •Previous selective dorsal rhizotomy
- •Presence of ataxia or dystonia
- •Cognitive problems that impede measurements
- •Severe co-morbidities (severe epilepsy, non-correctable visual impairment, autism spectrum disorders, mental problems that prevent comprehensiveness of the tasks)
- •Hospitalization after the BoNT treatment for intensive physical therapy
- •Intrathecal baclofen pump
- •For the control group: new intervention planned within 3 months
- •Additional exclusion criterion for the control group specifically: new intervention planned within 3 months
结局指标
主要结局
Change in Gait Profile Score (Degrees)
时间窗: Between baseline and 8-10 weeks after the BoNT injections
The Gait Profile Score (GPS) is a summary measure derived from three-dimensional gait analysis that quantifies the overall deviation of a patient's gait kinematics from a normative (typically developing) reference dataset. It is calculated as the root mean square difference between the patient's joint angle trajectories of the lower limb and the corresponding mean trajectories of typically developing individuals across a gait cycle. The GPS is expressed in degrees and is based on nine key kinematic variables: pelvic tilt, obliquity, rotation; hip flexion, abduction, rotation; knee flexion; ankle dorsiflexion; and foot progression angle, typically for both left and right sides. It provides a global index of gait abnormality, where lower scores indicate gait patterns closer to normal, and higher scores reflect greater kinematic deviation.
Change in the Spatial-temporal Parameter "Cadence".
时间窗: Between baseline and 8-10 weeks after the BoNT injections
Estimation of the cadence by three-dimensional gait analysis.
Change in the Spatial-temporal Parameter "Walking Velocity".
时间窗: Between baseline and 8-10 weeks after the BoNT injections
Estimation of the walking velocity by three-dimensional gait analysis.
Change in the Spatial-temporal Parameter "Stride Length".
时间窗: Between baseline and 8-10 weeks after the BoNT injections
Estimation of the stride length by three-dimensional gait analysis.
Change in Spasticity of the Medial Gastrocnemius and the Medial Hamstrings
时间窗: Between baseline and 8-10 weeks after the BoNT injections
Muscle activity of the medial gastrocnemius and the medial hamstrings as recorded by surface electromyography (millivolts) during a passive stretch at high velocity of the plantar flexors and the hamstrings.
Change in Normalized Muscle Volume of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus
时间窗: Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group.
Estimation of the muscle belly volume by three-dimensional freehand ultrasonography normalized to the product of body weight and height
Change in Echogenicity Intensity of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus
时间窗: Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group.
Estimation of the echogenicity intensity of the whole muscle volume by three-dimensional freehand ultrasonography. Echogenicity is expressed in arbitrary units ranging from 0 to 255. Higher values indicate lighter images, which indirectly suggests the presence of more non-contractile muscle tissue.
Absolute Muscle Volume Growth Rate of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus
时间窗: Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group.
Estimation of the absolute muscle volume growth rate, calculated by: (muscle volume (mL)post-muscle volume pre)/(age (months)post-age (months)pre)
Change in Kinematic Parameters
时间窗: Between baseline and 8-10 weeks after the BoNT injections
Estimation of the kinematic parameters throughout the whole gait cycle by three-dimensional gait analysis.
Change in Kinematic Parameters
时间窗: Between baseline and 8-10 weeks after the BoNT injections
Estimation of the kinematic parameters throughout the whole gait cycle by three-dimensional gait analysis.
Change in Normalized Muscle Volume of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus
时间窗: Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group.
Estimation of the muscle belly volume by three-dimensional freehand ultrasonography normalized to the product of body weight and height
Change in Echogenicity Intensity of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus
时间窗: Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group.
Estimation of the echogenicity intensity of the whole muscle volume by three-dimensional freehand ultrasonography. Echogenicity is expressed in arbitrary units ranging from 0 to 255. Higher values indicate lighter images, which indirectly suggests the presence of more non-contractile muscle tissue.
Change in Gait Profile Score (Degrees)
时间窗: Between baseline and 8-10 weeks after the BoNT injections
The Gait Profile Score (GPS) is a summary measure derived from three-dimensional gait analysis that quantifies the overall deviation of a patient's gait kinematics from a normative (typically developing) reference dataset. It is calculated as the root mean square difference between the patient's joint angle trajectories of the lower limb and the corresponding mean trajectories of typically developing individuals across a gait cycle. The GPS is expressed in degrees and is based on nine key kinematic variables: pelvic tilt, obliquity, rotation; hip flexion, abduction, rotation; knee flexion; ankle dorsiflexion; and foot progression angle, typically for both left and right sides. It provides a global index of gait abnormality, where lower scores indicate gait patterns closer to normal, and higher scores reflect greater kinematic deviation.
Change in the Spatial-temporal Parameter "Cadence".
时间窗: Between baseline and 8-10 weeks after the BoNT injections
Estimation of the cadence by three-dimensional gait analysis.
Change in the Spatial-temporal Parameter "Walking Velocity".
时间窗: Between baseline and 8-10 weeks after the BoNT injections
Estimation of the walking velocity by three-dimensional gait analysis.
Change in the Spatial-temporal Parameter "Stride Length".
时间窗: Between baseline and 8-10 weeks after the BoNT injections
Estimation of the stride length by three-dimensional gait analysis.
Change in Spasticity of the Medial Gastrocnemius and the Medial Hamstrings
时间窗: Between baseline and 8-10 weeks after the BoNT injections
Muscle activity of the medial gastrocnemius and the medial hamstrings as recorded by surface electromyography (millivolts) during a passive stretch at high velocity of the plantar flexors and the hamstrings.
次要结局
- Change in Normalized Muscle Tendon Unit Length of the Medial Gastrocnemius(Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group.)
- Change in Normalized Muscle Belly Length of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus(Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group.)
- Change in Normalized Tendon Length of the Medial Gastrocnemius(Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group.)
- Normalized Muscle Volume Growth Rates of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus(Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group.)
- Change in the Kinematic Parameter "Ankle Range of Motion in Sagittal Plane During Stance Phase"(Between baseline and 8-10 weeks after the BoNT injections)
- Change in the Kinematic Parameter "Knee Range of Motion in Sagittal Plane During Stance Phase"(Between baseline and 8-10 weeks after the BoNT injections)
- Change in Muscle Activation of the Medial Gastrocnemius and the Medial Hamstrings (i.e. the Change During the High-velocity Stretch).(Between baseline and 8-10 weeks after the BoNT injections)
- Change of Range of Motion in the Ankle and Knee Joint(Between baseline and 8-10 weeks after the BoNT injections)
- Change in Normalized Muscle Tendon Unit Length of the Medial Gastrocnemius(Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group.)
- Change in Normalized Muscle Belly Length of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus(Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group.)
- Change in Normalized Tendon Length of the Medial Gastrocnemius(Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group.)
- Normalized Muscle Volume Growth Rates of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus(Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group.)
- Change in the Kinematic Parameter "Ankle Range of Motion in Sagittal Plane During Stance Phase"(Between baseline and 8-10 weeks after the BoNT injections)
- Change in the Kinematic Parameter "Knee Range of Motion in Sagittal Plane During Stance Phase"(Between baseline and 8-10 weeks after the BoNT injections)
- Change in Muscle Activation of the Medial Gastrocnemius and the Medial Hamstrings (i.e. the Change During the High-velocity Stretch).(Between baseline and 8-10 weeks after the BoNT injections)
- Change of Range of Motion in the Ankle and Knee Joint(Between baseline and 8-10 weeks after the BoNT injections)
研究者
Kaat Desloovere
Prof. Dr.
Universitaire Ziekenhuizen KU Leuven