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

niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年5月6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 (10m walking test)
•- being able to stand and walk for 10m without aids

•- 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 (severe ankle contracture)
•- osteoporosis, defined by a T-score -2.5 or below (based on bone mineral density in DXA-assessment)
•- the use of anti-coagulation drugs (coumarin and/or heparin derivates)
•- pregnancy
•- addiction to drugs or alcohol
•- any inability to cooperate with the assessments and to give written informed consent

发起方

niversitair Medisch Centrum Sint Radboud