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

Phase 4

Completed

Conditions: Hereditary Spastic Paraparesis
hereditary spasticity of the lower limbs
10029299
10041543

Registration Number: NL-OMON32926

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

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
- any inability to cooperate with the assessments and to give written informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Dynamic balance is selected as the primary outcome and expressed as the success<br /><br>rate after external perturbations, i.e. the percentage of successful trials<br /><br>during which upright standing can be maintained without making a step or<br /><br>grabbing for support.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Gait velocity, calf muscle activation patterns and ankle joint power during the<br /><br>push-off are selected as secondary outcome parameters of gait. Maximal<br /><br>voluntary force of the plantar flexors and the integrity of the corticospinal<br /><br>tract are expected to be determinants of the effect of BTX-A.</p><br>