Functional effects of botulinum toxin in the hip adductors and subsequent exercise in patients with hereditary spastic paraplegia

Phase 3

Completed

Conditions: Hereditary spastic paraplegia (HSP) and Strumpell disease
10029317

Registration Number: NL-OMON42682

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

- diagnosis of pure HSP based on molecular diagnosis (e.g. SPG-4 mutations) or based on inheritance
- age at least 18 years
- suffer from (bilateral) hip adductor spasticity without contracture (modified Ashworth scale score 1-4)
- being a minimally independent household ambulator without walking aid (Functional Ambulation Categories 4-5)
- gait velocity > 0.4 m/s
- complaining of balance problems due to a narrow base of support or problems with lateral stepping

Exclusion Criteria

- Last BTX-A treatment of the hip adductors is shorter than 6 months ago
- Any previous BTX-A injections in the calf muscles are accepted, but it must be possible to safely postpone subsequent injections of these muscles for 4 months after inclusion
- Insufficient vision
- Insufficient cardiopulmonary endurance
- Insufficient sensorimotor abilities

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcomes are lateral stepping and gait widthy. Those outcomes will<br /><br>be measured as the change in frontal-plane leg angle during bilateral stepping<br /><br>at the individually determined max level of perturbation intensity (without<br /><br>support) and the change in gait width during normal walking. For both<br /><br>parameters the difference between baseline to endpoint will be determined</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters are the scores on the next assessments:<br /><br>- Balance confidence<br /><br>- Berg Balance Scale<br /><br>- Comfortable and maximum overground gait velocity<br /><br>- 6-Min Walk Test<br /><br>- Timed Up and Go test<br /><br>- Gait adaptability</p><br>