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.

The effect of lidocaïne injections in the m. vastus intermedius and the m. rectus femoris on the gait pattern in patients walking with stiff knee gait after a stroke. - lidocaine injections in the vastus intermedius and rectus femoris in stiff knee gait after a stroke

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000403-32-NL

Enrollment

Registered

2019-07-17

Start date

2019-07-23

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Patients walking with stiff knee gait after a stroke

Interventions

Trade Name: Accord Healthcare B.V., Utrecht, Netherlands Product Name: Lidocaine hydrochloride Product Code: RVG 115422 Pharmaceutical Form: Solution f

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Determining the effect of lidocaine injections in the m. vastus intermedius and the m. rectus femoris on the knee flexion in patients walking with stiff knee gait after a stroke.; Secondary Objective: - Determining the effect of lidocaine injection in the m. vastus intermedius in patients walking with stiff knee gait after a stroke on the kinetics and kinematics of the ankle, knee, hip and pelvis during gait. - Determining the effect of lidocaine injections in the m. vastus intermedius and the m. rectus femoris in patients walking with stiff knee gait after a stroke on the kinetics and kinematics of the ankle, knee, hip and pelvis during gait. - Determining the effect of lidocaine injections on the improvement as experienced by the patient measured with the BORG and VAS scales for knee stiffness. ;Primary end point(s): Knee flexion during gait measured in degrees with 3D analysis (VICON);Timepoint(s) of evaluation of this end point: all endpoints are measured within 2 hours after the first injections	—

Measure

Time frame

Main Objective: Determining the effect of lidocaine injections in the m. vastus intermedius and the m. rectus femoris on the knee flexion in patients walking with stiff knee gait after a stroke.; Secondary Objective: - Determining the effect of lidocaine injection in the m. vastus intermedius in patients walking with stiff knee gait after a stroke on the kinetics and kinematics of the ankle, knee, hip and pelvis during gait. - Determining the effect of lidocaine injections in the m. vastus intermedius and the m. rectus femoris in patients walking with stiff knee gait after a stroke on the kinetics and kinematics of the ankle, knee, hip and pelvis during gait. - Determining the effect of lidocaine injections on the improvement as experienced by the patient measured with the BORG and VAS scales for knee stiffness. ;Primary end point(s): Knee flexion during gait measured in degrees with 3D analysis (VICON);Timepoint(s) of evaluation of this end point: all endpoints are measured within 2 hours after the first injections

—

Secondary

Measure	Time frame
Secondary end point(s): - Kinematics of the ankle, knee, hip and pelvis measured by 3D analysis (VICON) - Kinetics of the ankle, knee, hip and pelvis - BORD and VAS questionnaires on knee stability and stiffness. ;Timepoint(s) of evaluation of this end point: All endpoints are measured within 2 hours after the first injections	—

Countries

Netherlands

Contacts

Public ContactMartin Tenniglo

Roessingh Research and Development

m.tenniglo@rrd.nl00310880875777

Outcome results

None listed

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