The effect of lidocaïne (muscle relaxant) in two muscles of the upper leg in people who had a stroke and walk with a stiff knee because of the stroke.

Phase 1

• Conditions: Patients walking with stiff knee gait after a stroke; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2019-000403-32-NL
• Lead Sponsor: Roessingh Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-17
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

- Age > 18 years old
- The stroke is more then six months ago
- Patient is walking with stiff knee gait (reduced knee flexion during swing fase)
- Patients is able to walk independently (FAC = 3)
- Overactivity of the m. vastus intermedius and m. rectus femoris (EMG)
- Patient is capable to understand and follow instructions
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 18
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Problems that influence the gait pattern that are not caused by the stroke
- Allergy or hypersensitivity for lidocaine or a previous allergic reaction to lidocaine
- Inflamation in the injection area

Study & Design

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