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

Functional effects of botulinum toxin in the hip adductors and subsequent exercise in patients with hereditary spastic paraplegia: a pilot RCT - FEBOCH-II

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003184-11-NL

Enrollment

Registered

2015-10-20

Start date

2016-01-04

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary Spastic Paraplegia

Interventions

Trade Name: Xeomin Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Netherlands

Contacts

Public ContactInvestigator

Radboud University Medical Centre

Bas.vanLith@radboudumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026