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

Phase 3

Completed

• Conditions: stiff knee gait; stiff-legged knee; 10007963; 10057166

• Registration Number: NL-OMON39359
• Lead Sponsor: Revalidatiecentrum Het Roessingh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 26

Inclusion Criteria

age over 18 years
6 months post stroke
patient walks with a stiff knee gait caused by an overactivity of the m. rectus femoris
able to walk independent
overactivity of the m. rectus femoris, established with EMG-measures

Exclusion Criteria

presence of other constraints in joints who impede walking
neurological problems not causes by a Cerebro Vascular Accident
patient walks with a diminished knee flexion as a result of an orthopedic cause
myasthenia gravis or Eaton-Lambert syndrome
progressive clinical picture which influence the gait pattern
use of amfotericine B en/of amsacrine
pregnancy / nursing mothers

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- VICON 3D analysis to determine knee flexion during swing phase<br /><br>- Pulmonary function test to determine the energy cost during walking (measured<br /><br>with CosMed K4b2)<br /><br>- Electromyogram (EMG) measurements<br /><br>- BORG and VAS questionnaire for tonus<br /><br>- Duncan-Ely test<br /><br>- Kinematics (measured with VICON 3D gait analysis)<br /><br>- Kinetics (measured with force plates)<br /><br>- Muscle Activation in Pendulum, Passive and Active Movements Test (MAPPAM)<br /><br>- Motricity Index<br /><br>- Rivermead Mobility Index<br /><br>- 6 minutes walk test<br /><br>- Timed Up and Go test</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Stroke Impact Scale</p><br>