Department of Rehabilitation Medicine and the EGMO+ Institute for Health and Care Research, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands.
BMC Pediatr. 2012 Mar 26;12:38. doi: 10.1186/1471-2431-12-38.
Range of motion deficits of the lower extremity occur in about the half of the children with spastic cerebral palsy (CP). Over time, these impairments can cause joint deformities and deviations in the children's gait pattern, leading to limitations in moblity. Preventing a loss of range of motion is important in order to reduce secondary activity limitations and joint deformities. Sustained muscle stretch, imposed by orthotic management in rest, might be an effective method of preventing a decrease in range of motion. However, no controlled study has been performed.
A single blind randomised controlled trial will be performed in 66 children with spastic CP, divided over three groups with each 22 participants. Two groups will be treated for 1 year with orthoses to prevent a decrease in range of motion in the ankle (either with static or dynamic knee-ankle-foot-orthoses) and a third group will be included as a control group and will receive usual care (physical therapy, manual stretching). Measurements will be performed at baseline and at 3, 6, 9 and 12 months after treatment allocation. The primary outcome measure will be ankle dorsiflexion at full knee extension, measured with a custom designed hand held dynamometer. Secondary outcome measures will be i) ankle and knee flexion during gait and ii) gross motor function. Furthermore, to gain more insight in the working mechanism of the orthotic management in rest, morphological parameters like achilles tendon length, muscle belly length, muscle fascicle length, muscle physiological cross sectional area length and fascicle pennation angle will be measured in a subgroup of 18 participants using a 3D imaging technique.
This randomised controlled trial will provide more insight into the efficacy of orthotic management in rest and the working mechanisms behind this treatment. The results of this study could lead to improved treatments.
Nederlands Trial Register NTR2091.
大约一半的痉挛性脑瘫(CP)患儿存在下肢活动度不足的问题。随着时间的推移,这些损伤可能导致关节畸形和步态模式的偏差,从而限制患儿的活动能力。防止活动度丧失对于减少继发性活动受限和关节畸形非常重要。在休息时通过矫形器管理施加持续的肌肉拉伸可能是预防活动度下降的有效方法。然而,目前尚未进行对照研究。
将 66 名痉挛性 CP 患儿分为三组,每组 22 名患儿,进行单盲随机对照试验。两组患儿将接受 1 年的矫形器治疗,以防止踝关节活动度下降(使用静态或动态膝踝足矫形器),第三组为对照组,接受常规治疗(物理治疗、手动拉伸)。治疗分配后,将在基线、3、6、9 和 12 个月时进行测量。主要结局测量指标为全膝关节伸展时的踝关节背屈,使用定制的手持测力计进行测量。次要结局测量指标为:i)步态时的踝关节和膝关节屈曲,ii)粗大运动功能。此外,为了更深入地了解休息时矫形器管理的工作机制,将在 18 名参与者的亚组中使用 3D 成像技术测量跟腱长度、肌肉腹长度、肌束长度、肌肉生理横截面积长度和肌束羽状角等形态学参数。
这项随机对照试验将提供更多关于休息时矫形器管理的疗效以及这种治疗背后的工作机制的信息。该研究的结果可能会导致治疗方法的改进。
荷兰临床试验注册中心 NTR2091。