NL-OMON32926
Completed
Phase 4
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 sites20 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Hereditary Spastic Paraparesis
- Sponsor
- niversitair Medisch Centrum Sint Radboud
- Enrollment
- 20
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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