Functional effects of botulinum toxin in the hip adductors and subsequent exercise in HSP patients

Phase 1

• Conditions: Hereditary Spastic Paraplegia; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-003184-11-NL
• Lead Sponsor: Radboud University Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-20
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• 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
-complain of balance problems due to a narrow base of support or problems with lateral stepping

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 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Last BTX treatment of the hip adductors is shorter than 6 months ago or when a next BTX treatment of these muscles cannot be postponed for 4 months without increasing fall risk or jeopardizing patients’ safety in any other way.
-Any previous BTX 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: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objectives of this study is to investigate whether BTX injections, injected bilaterally in the spastic adductors of patients with HSP can improve lateral stepping and gait width. ;Secondary Objective: The secondary objectives are balance confidence, Berg Balance Scale, comfortable and maximum overground gait velocity, 6-Min Walk Test, Timed Up and Go test and gait adaptability.;Primary end point(s): Increased succesratio of recovering balance by a lateral step. Increased frontal leg angle. Increased gait width;Timepoint(s) of evaluation of this end point: before, 6 weeks and 16 weeks after the injection

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Increased balance confidence, gait velocity and gait adaptability;Timepoint(s) of evaluation of this end point: before, 6 weeks and 16 weeks after the injection