EA 7377 BIOTN, Service de Rééducation Neurolocomotrice, Université Paris-Est Créteil, Hospital Albert Chenevier-Henri Mondor, Créteil, France.
Biometry, Ipsen Pharma, Boulogne-Billancourt, France.
Clin Rehabil. 2020 Jun;34(6):803-811. doi: 10.1177/0269215520911970. Epub 2020 Apr 26.
The aim of this study is to evaluate a novel composite measure of active range of motion (X) and determine whether this measure correlates with active function.
Post hoc analysis of two randomized, placebo-controlled, double-blind studies with open-label extensions exploring changes in active function with abobotulinumtoxinA.
Tertiary rehabilitation centers in Australia, Europe, and the United States.
Adults with upper ( = 254) or lower ( = 345) limb spastic paresis following stroke or brain trauma.
AbobotulinumtoxinA (⩽5 treatment cycles) in the upper or lower limb.
X was used to calculate a novel composite measure (CX), defined as the sum of X against elbow, wrist, and extrinsic finger flexors (upper limb) or soleus and gastrocnemius muscles (lower limb). Active function was assessed by the Modified Frenchay Scale and 10-m comfortable barefoot walking speed in the upper limb and lower limb, respectively. Correlations between CX and active function at Weeks 4 and 12 of open-label cycles were explored.
CX and active function were moderately correlated in the upper limb ( < 0.0001-0.0004, = 0.476-0.636) and weakly correlated in the lower limb ( < 0.0001-0.0284, = 0.186-0.285) at Weeks 4 and 12 of each open-label cycle. Changes in CX and active function were weakly correlated only in the upper limb (Cycle 2 Week 12, = 0.0160, = 0.213; Cycle 3 Week 4, = 0.0031, = 0.296). Across cycles, CX improvements peaked at Week 4, while functional improvements peaked at Week 12.
CX is a valid measure for functional impairments in spastic paresis. CX improvements following abobotulinumtoxinA injection correlated with and preceded active functional improvements.
本研究旨在评估一种新的主动活动范围（X）综合测量方法，并确定该方法是否与主动功能相关。
对两项探索 abobotulinumtoxinA 对主动功能变化的随机、安慰剂对照、双盲研究进行事后分析，并进行开放性标签扩展。
澳大利亚、欧洲和美国的三级康复中心。
上肢（ = 254）或下肢（ = 345）卒中或脑外伤后痉挛性瘫痪的成人。
上肢或下肢接受 abobotulinumtoxinA（ ⩽5 个治疗周期）。
X 用于计算一种新的综合测量方法（CX），定义为肘部、腕部和外在手指屈肌（上肢）或比目鱼肌和腓肠肌（下肢）对抗 X 的总和。主动功能分别采用改良 Frenchay 量表和 10 m 舒适赤脚步行速度进行评估。探索 CX 与开放性周期第 4 周和第 12 周的主动功能之间的相关性。
在每个开放性周期的第 4 周和第 12 周，CX 与上肢的主动功能呈中度相关（ < 0.0001-0.0004， = 0.476-0.636），与下肢的主动功能呈弱相关（ < 0.0001-0.0284， = 0.186-0.285）。只有在上肢，CX 和主动功能的变化呈弱相关（第 2 周期第 12 周， = 0.0160， = 0.213；第 3 周期第 4 周， = 0.0031， = 0.296）。跨周期，CX 的改善在第 4 周达到峰值，而功能的改善在第 12 周达到峰值。
CX 是痉挛性瘫痪患者功能障碍的有效测量方法。abobotulinumtoxinA 注射后 CX 的改善与主动功能的改善相关，并先于主动功能的改善。
