The Effect of Selective Dorsal Rhizotomy on a Multidimensional Outcome Set in Children With Spastic Cerebral Palsy: a Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Overall changes in muscle length of the medial gastrocnemius
研究概览
简要总结
Cerebral palsy or CP is the single largest cause of childhood physical disability, with a prevalence of 2-3 per 1000 livebirths. Children with CP experience different primary symptoms, including abnormal increased muscle tone or spasticity. Selective dorsal rhizotomy (SDR) is applied in children with spastic CP as a non-reversible tone reduction procedure. Better understanding of the effects of SDR on a multidimensional outcome set in one CP-cohort and on macroscopic muscle morphology can improve insights and clinical decision making.
详细描述
Cerebral palsy or CP is the single largest cause of childhood physical disability, with a prevalence of 2-3 per 1000 livebirths. Children with CP experience different primary symptoms, including abnormal increased muscle tone or spasticity. Selective dorsal rhizotomy (SDR) is applied in children with spastic CP as a non-reversible tone reduction procedure. During this neurosurgical procedure, dorsal rootlets are transected to diminish the excitatory input from the afferents, resulting in a reduction of the abnormal, increased muscle tone. Although different studies investigated the SDR-effect on separate sets of outcomes, such as spasticity, gait or gross motor function, no study so far has studied SDR-effects on combined outcome sets in one CP-cohort or on macroscopic muscle morphology.
The discrepancy between results of different previous studies highlight the added value of a multidimensional outcome set assessed within one cohort. Integrating outcomes of different levels will provide a better insight on how effects do or do not occur. Additionally, although SDR does not directly intervene with the macroscopic muscle structures, reducing the excitatory input from the afferents could potentially have an effect on muscle growth. Indicating macroscopic muscle morphology as an important outcome.
The current study will investigate the added value of a multidimensional outcome set, assessed in one single cohort. Important gaps in the literature will be addressed, including the effect of SDR on muscle morphology and the use of instrumented assessments. The primary objective of this study was to investigate changes in a multidimensional outcome set (including spasticity, muscle morphology, gait and gross motor function) pre- and post-SDR, in one single cohort of children with spastic CP. As a secondary objective, this study will compare outcomes of the clinical examination (spasticity, range of motion, strength, selectivity) pre- and post-SDR. Additionally, muscle morphology will be qualitatively compared in children with CP who received an SDR to children with CP without an SDR intervention.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spastic CP, Uni- or bilateral involvement
- •Gross Motor Classification System (GMFCS) levels I to III
- •Children: 5 to 16 years of age at time of SDR
- •SDR intervention
- •Clinical follow-up pre- and post-SDR at the Clinical Motion Analysis Laboratory Pellenberg (CMAL, UZ Leuven, Campus Pellenberg)
排除标准
- •Presence of dystonia or ataxia
- •SDR intervention in combination with muscle surgery
- •Severe co-morbidities (that are likely to prevent proper assessment, such as severe cognitive problems)
结局指标
主要结局
Overall changes in muscle length of the medial gastrocnemius
时间窗: pre- and one year post-SDR
Estimation of the muscle belly length, tendon length and muscle tendon unit complex length, measured by 3DfUS. Muscle lengths will be expressed absolute and normalized to anthropometric growth.
Overall changes in muscle cross-sectional area at 50% of muscle belly length
时间窗: pre- and one year post-SDR
Estimation of the muscle belly cross-sectional area at 50% of the muscle belly length, measured by 3DfUS. Muscle cross-sectional area will be expressed absolute and normalized to anthropometric growth.
Overall changes in gait
时间窗: pre- and one year post-SDR
Gait was measured with three-dimensional gait analysis. The specific outcomes are the gait profile score and the gait variable scores of the ankle and the knee. Parameters were calculated using the reference database of typically developing children.
Overall changes in spasticity
时间窗: pre- and one year post-SDR
The specific outcome is the difference in the root mean square value of the surface-EMG signals between the low- and high-velocity passive stretches, expressed both absolute and normalized to the maximum voluntary contraction.
Overall change in muscle volume of the medial gastrocnemius
时间窗: pre- and one year post-SDR
Estimation of the muscle belly volume, measured by 3DfUS. Muscle volume will be expressed absolute and normalized to anthropometric growth.
Overall change in gross-motor function
时间窗: pre- and one year post-SDR
Gross-motor function was measured with the Gross-motor function measure 66- item set, resulting in a total score.
次要结局
- Overall change of selectivity in the plantar flexors(pre- and one year post-SDR)
- Overall change of passive range of motion in the ankle and knee joint(pre- and one year post-SDR)
- Overall change of spasticity in the plantar flexors(pre- and one year post-SDR)
- Overall change of muscle strength in the plantar flexors(pre- and one year post-SDR)
- Scatter plots of muscle morphology data (same parameters as for the primary endpoints)(SDR (pre- and one year post-SDR )vs no SDR (a database of children with CP who were not treated with SDR, one timepoint))
研究者
Kaat Desloovere
prof. dr.
Universitaire Ziekenhuizen KU Leuven