The effect of botulinum toxin type A injections in the m. rectus femoris in stroke patients presenting with a stiff knee gait. - Botulinum toxin type A injections in stiff knee gait

• Conditions: Stroke patients with stiff knee gait. Stiff knee gait is characterized as a diminished knee flexion during swing phase of gait. It is common in stroke patients.

• Registration Number: EUCTR2009-018226-29-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

- age >18 years
- six months ago after stroke
- patient walks with a stiff knee gait
- patient is able to walk independent
- overactivity of the m. rectus femoris is present, determined with EMG-measurements
- patient is orientated in time, place and person
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Presentation of other conditions in joints which decrease walking
- Patient walks with a diminished knee flexion through an orthopedi cause
- Progressive clinical picture which influence gait
- Allergic reaction on Botox or a botulinum toxin product
- Botulinum toxin injection in the last 4 months
- Pregnancy and given breast feeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the effect of botulinum toxin type A injections in the m. rectus femoris in stroke patients with stiff knee gait on function- and activity level;Secondary Objective: To determine the effect of botulinum toxin type A injections in the m. rectus femoris in stroke patients with stiff knee gait on participation level;Primary end point(s): Improved Range Of Motion (flexion-extension) of the knee during swing in stroke patients with stiff knee gait after botulinum toxin type A injections.