Treatment Algorithms Based on Muscle and Tendon Morphology - Progressive Supervised Home-based Strength Training in Children With Spastic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Change in Muscle Size Parameter
研究概览
简要总结
A randomized controlled trail will be carried out to investigate the effect of a 12-week supervised home-based progressive strength intervention in children with spastic cerebral palsy aged 5-11 years. The results of this strength intervention aiming for increased strength and muscle hypertrophy will serve as input for a clinical decision making framework based on muscle and tendon architecture.
详细描述
Background: The alterations of morphological muscle and tendon properties are a primary determinant of the pathological muscle behaviour in spastic cerebral palsy (SCP). As treatments aim to reduce the progressive secondary problems, they are mainly directed at the muscle level. Muscle morphology features like volume, fascicle architecture and tendon properties are all responsive to treatment, but these treatment responses seem to be both patient and muscle-specific. Therefore, objective tools and protocols are needed for the evaluation of morphological muscle and tendon (MMT) properties in routine clinical practice. These are required to guide the patient-specific selection of appropriate, rationalized treatment choices and to determine the impact of these treatments on the MMT properties, the muscular impairment and function in children with SCP.
This intervention study is one out of three intervention studies focused on defining the effects of conservative treatments (strengthening, stretching and botulinum toxin injections) on muscle and tendon architecture. In this phase of the Treatment Algorithms based on Muscle and Tendon Morphology (TAMTA) project, we aim to develop specific guidelines for these treatment options linked to the MMT evaluation protocol. To achieve this goal, prediction models based on baseline MMT parameters for the prognosis of specific treatment outcomes will be developed from the data of the three intervention studies.
Aim: (1) determine whether the 12-week program of targeted progressive strengthening of the plantar flexors, the knee flexors and extensors leads to changes in the MMT properties of medial gastrocnemius, semitendinosus and rectus femoris, in the muscle strength and in gross motor function; and (2) determine the correlation between baseline MMT properties and the changes in the outcome parameters.
Methods/Design: A randomized controlled trial will be conducted in 40 ambulatory children with a confirmed diagnosis of SCP between 5 and 11 years of age. Participants will be randomized to the intervention group (who will additionally receive the strengthening program while continuing their usual care) or to the waitlist-control group (who will continue their usual care without additional treatment) using the randomization by minimization method (with influencing characteristics age and GMFCS level). Participants in the control group will be able to participate in the intervention after the control period. The MMT parameters of the medial gastrocnemius, tibialis anterior, semitendinosus and rectus femoris and the isometric and functional strength for the 4 related lower limb muscle groups (plantar flexors, dorsiflexors, knee flexors and knee extensors) as well as the gross motor function will be assessed before and after the 12-week program. After 6 weeks a short evaluation of the MMT parameters, isometric and functional strength will take place.
The change in primary outcome parameters before and after training of the intervention group will be compared to the data behaviour of the control group. Secondly, to explore the predictive value of specific baseline MMT parameters on treatment effect, both univariate and multivariate linear regression analyses will be conducted to identify significant predictive variables for the primary outcome parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of SCP
- •Aged 5-12 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
排除标准
- •Non-ambulatory
- •Botulinum toxin A injections six months prior to enrollment
- •Lower limb surgery two years prior to enrollment
- •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)
研究组 & 干预措施
Intervention group
During a 12-week period children receive 3-4 sessions of progressive strength training per week on top of the usual care. All children will be provided with an individualized training program and supporting equipment. One or 2 session per week will be performed under supervision of the physical therapist, whilst the remaining sessions will be performed at home. Progression is closely monitored by the principal investigator and training programs are adjusted if necessary.
干预措施: Progressive strength training (Behavioral)
Waitlist-control group
The waitlist-control group will continue their usual care without additional treatment for 12-weeks, followed by a 12-week period of progressive supervised home-based strength training.
结局指标
主要结局
Change in Muscle Size Parameter
时间窗: baseline, post-intervention (12-weeks)
Estimation of muscle volume by 3D freehand ultrasonography.
Change in Muscle Length
时间窗: baseline, post-intervention (12-weeks)
Estimation of muscle length parameters by 3D freehand ultrasonography from origo to muscle tendon junction.
Change in Echogenicity Intensity
时间窗: baseline, post-intervention (12-weeks)
Estimation of echogenicity intensity by 3D freehand ultrasonography on an 8-bit greyscale (256 values ranging from 0 to 255). Echogenicity intensity was defined over the whole muscle volume. Echogenicity intensity refers to the brightness of a muscle seen on the ultrasound image, which reflects how much sound is being bounced back (or "echoed") by the tissue. Higher echo-intensity (i.e., higher values) often indicates increased fat or fibrous tissue within the muscle and is therefore seen as a worse outcome. Whereas low echo-intensity (i.e., lower values) indicate less non-muscular tissue in the muscle, therefor higher quality and a better outcome.
Change in Functional Muscle Strength - Muscle Endurance
时间窗: baseline, post-intervention (12-weeks)
Evaluation of functional muscle strength by 30-sec maximum repetition tests of the Adapted Functional Strength measure. For unilateral exercises (lateral step-up and unilateral heel raise) all affected legs were assessed.
Change in Functional Muscle Strength - Maximum Jumping Distance
时间窗: baseline, post-intervention (12-weeks)
Evaluation of standing long jump by the Adapted Functional Strength measure.
Change in Muscle Size Parameter
时间窗: baseline, post-intervention (12-weeks)
Estimation of muscle volume by 3D freehand ultrasonography.
Change in Muscle Length
时间窗: baseline, post-intervention (12-weeks)
Estimation of muscle length parameters by 3D freehand ultrasonography from origo to muscle tendon junction.
Change in Echogenicity Intensity
时间窗: baseline, post-intervention (12-weeks)
Estimation of echogenicity intensity by 3D freehand ultrasonography on an 8-bit greyscale (256 values ranging from 0 to 255). Echogenicity intensity was defined over the whole muscle volume. Echogenicity intensity refers to the brightness of a muscle seen on the ultrasound image, which reflects how much sound is being bounced back (or "echoed") by the tissue. Higher echo-intensity (i.e., higher values) often indicates increased fat or fibrous tissue within the muscle and is therefore seen as a worse outcome. Whereas low echo-intensity (i.e., lower values) indicate less non-muscular tissue in the muscle, therefor higher quality and a better outcome.
Change in Isometric Muscle Strength
时间窗: baseline, post-intervention (12-weeks)
Evaluation of isometric muscle strength by Instrumented Weakness Assessment.
Change in Functional Muscle Strength - Muscle Endurance
时间窗: baseline, post-intervention (12-weeks)
Evaluation of functional muscle strength by 30-sec maximum repetition tests of the Adapted Functional Strength measure. For unilateral exercises (lateral step-up and unilateral heel raise) all affected legs were assessed.
Change in Functional Muscle Strength - Maximum Jumping Distance
时间窗: baseline, post-intervention (12-weeks)
Evaluation of standing long jump by the Adapted Functional Strength measure.
次要结局
- Change in Walking Capacity(baseline, post-intervention (12 weeks))
- Change in Gross Motor Function(baseline, post-intervention (12 weeks))
- Change in Walking Capacity(baseline, post-intervention (12 weeks))
- Change in Gross Motor Function(baseline, post-intervention (12 weeks))
研究者
Kaat Desloovere
Prof. Dr.
Universitaire Ziekenhuizen KU Leuven