Botulinum toxin for treating calf muscle spasticity in Hereditary Spastic Paraparesis (HSP): functional effects on dynamic balance and gait - FEBOCH

Radboud University Nijmegen Medical Centre0 个研究点目标入组 20 人开始时间: 2009年5月6日最近更新: 2021年4月5日

适应症

试验速览

暂无简介。

•-diagnosis based on molecular diagnosis (e.g. SPG-4 mutations)
•-age between 18 and 70 years
•-disabling bilateral calf muscle spasticity (including clonus) without excessive passive stiffness or contracture (i.e. Modified Ashworth Scale 1-3 / 5)
•-comfortable walking speed greater than 1 km/hr (using a 10m walking test)
•-being able to stand and walk for 10m without aids
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•-impaired tactile and joint motion perception, or cerebellar signs, suggesting ‘complicated’ HSP
•-other disorders of the neuro-musculo-skeletal system
•-prior treatment with botulinum toxin or neurolysis of the lower limbs within 6 months
•-unwillingness or impossibility to keep any oral spasmolytic drugs constant
•-severe (> 15 degrees) contracture at the knees or hip joints
•-being unable to load the heels while standing with extended knees (due to ankle contracture)
•-pregnancy
•-addiction to drugs or alcohol
•-any inability to cooperate with the assessments and to give written informed consent

发起方

Radboud University Nijmegen Medical Centre