Botulinum toxin for treating calf muscle spasticity in Hereditary Spastic Paraparesis (HSP): functional effects on dynamic balance and gait - FEBOCH
- Conditions
- Subjects with hereditary spastic paraparesis (HSP)MedDRA version: 9.1Level: LLTClassification code 10019903Term: Hereditary spastic paraplegia
- Registration Number
- EUCTR2009-012073-34-NL
- Lead Sponsor
- Radboud University Nijmegen Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method