Botulinum toxin type A injections in stiff knee gait.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29171

Enrollment

Registered

2010-01-18

Start date

2013-03-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

In the Netherlands live about 18.000 Cerebro Vascular Accident (CVA)-patients which discover problems with walking caused by insufficient footclearance. Causes of problems with the footclearance during the swing phase of gait are a combination of diminished dorsal flexion of the ankle, knee flexion and hip flexion. A diminished knee flexion during swing is defined a stiff knee gait. A stiff knee gait is often caused by an overactivity of the m. rectus femoris. Keywords: stroke, stiff knee gai

Interventions

Botulinum toxin type A injections (Botox®). Botox® is a neurotransmitter which reduce the release of acetylcholine. This causes a muscle paralysis for 12 weeks. Botulinum toxin type A is injected at 6

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age over 18 years; 2. 6 months post stroke; 3. Patient walks with a stiff knee gait, caused by an overactivity of the m. rectus femoris; 4. Able to walk independent.

Exclusion criteria

Exclusion criteria: 1. Presence of other constraints in joints who impede walking; 2. Neurological problems not causes by a Cerebro Vascular Accident; 3. Patient walks with a diminished knee flexion as a result of an orthopedic cause; 4. Progressive clinical picture which influence the gait pattern.

Design outcomes

Primary

Measure	Time frame
1. VICON 3D analysis to determine knee flexion during swing phase; 2. Electromyogram (EMG) measurements; 3. BORG and VAS questionnaire for tonus; 4. Duncan-Ely test; 5. Kinematics (measured with VICON 3D gait analysis); 6. Kinetics (measured with force plates); 7. Muscle Activation in Pendulum, Passive and Active Movements Test (MAPPAM); 8. Motricity Index; 9. Rivermead Mobility Index; 10. 6 minutes walk test; 11. Timed Up and Go test.	—

Measure

Time frame

1. VICON 3D analysis to determine knee flexion during swing phase; 2. Electromyogram (EMG) measurements; 3. BORG and VAS questionnaire for tonus; 4. Duncan-Ely test; 5. Kinematics (measured with VICON 3D gait analysis); 6. Kinetics (measured with force plates); 7. Muscle Activation in Pendulum, Passive and Active Movements Test (MAPPAM); 8. Motricity Index; 9. Rivermead Mobility Index; 10. 6 minutes walk test; 11. Timed Up and Go test.

—

Secondary

Measure	Time frame
Stroke Impact Scale.	—

Contacts

Public ContactG. Snoek

Roessingh Research and Development, Reoessinghsbleekweg 33 B

g.snoek@rrd.nl+31 (0)53 4875777

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)