To determine the effect of botulinum toxin type A injections in stroke patients with stiff knee gait.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- VICON 3D analysis to determine knee flexion during swing phase
- Pulmonary function test to determine the energy cost during walking (measured
with CosMed K4b2)
- Electromyogram (EMG) measurements
- BORG and VAS questionnaire for tonus
- Duncan-Ely test
- Kinematics (measured with VICON 3D gait analysis)
- Kinetics (measured with force plates)
- Muscle Activation in Pendulum, Passive and Active Movements Test (MAPPAM)
- Motricity Index
- Rivermead Mobility Index
- 6 minutes walk test
- Timed Up and Go test
Secondary outcome
- Stroke Impact Scale
Background summary
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. A
stiff knee caused by an overactivity of the rectus femoris can improve by
botulinum toxin type A injections. Botulinum toxin type A injections create a
local muscle paralysis, which decrease overactivity in the m. rectus femoris.
Study objective
To determine the effect of botulinum toxin type A injections in stroke patients
with stiff knee gait.
Study design
A randomized controlled cross-over design. Patients will be randomized in group
A or group B. Randomisation will be done by an independent person and takes
place by blockrandomisation. A computer generated model randomize blocks of
four patients, two patients in group A and two patients in group B.
Interventions will be allocate after inclusion. Subjects and researchers who
measure outcomes are blinded. Group A receives first a placebo-injection and
group B receives first a botulinum toxin type A injection. After 5 months (4
months effect of the intervention + 1 month wash-out) group A receives a
botulinum toxin type A injection and group B receives a placebo-injection.
Intervention
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 points in the m. rectus femoris
(200U).
NatriumChloride (NaCl) is the placebo injection and is injected at the same way
as the botulinum toxin type A injection.
Study burden and risks
In a period of 7 months patient comes 4 mornings at the Roessingh Research and
Development for measurements. Patient walks 8 times over a distance of 7,5
metre with 3 different velocities, do simple tests and fill in 3
questionnaires. There is a very small risk that the patients report very little
adverse effects of the injections. In case of presence of adverse effects they
will disappear in a little time. There are no known definitive adverse effects
of botulinum toxin type A injections.
Roessinghsbleekweg 33
enschede 7522 AH
NL
Roessinghsbleekweg 33
enschede 7522 AH
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-018226-29-NL |
| CCMO | NL31114.044.10 |
| Other | TC = 2169 |