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Botulinum toxin type A injections in stiff knee gait.


- candidate number6891
- NTR NumberNTR2169
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-jan-2010
- Secondary IDs2009-018226-29 EudraCT
- Public TitleBotulinum toxin type A injections in stiff knee gait.
- Scientific TitleThe effect of botulinum toxin type A injections in the m. rectus femoris in stroke patients presenting with stiff knee gait.
- ACRONYM
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedMusculoskeletal disorders (MSDs), Stroke, Knee
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2013
- planned closingdate31-dec-2013
- Target number of participants26
- InterventionsBotulinum 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.
- Primary outcome1. 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 outcomeStroke Impact Scale.
- Timepointst0: baseline measurement before intervention;
t1: effect measurement (6 weeks after injection);
t2: baseline measurement after cross-over (5 months after t0);
t3: effect measurement (6 weeks after t2 measurement).
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. G. Snoek
- CONTACT for SCIENTIFIC QUERIES M. Tenniglo
- Sponsor/Initiator Roessingh Research and Development
- Funding
(Source(s) of Monetary or Material Support)
Roessingh Research & Development, Roessingh Rehabilitation Center
- PublicationsN/A
- Brief summaryBackground of the study:
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.

Objective of the study:
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.

Study population:
26 stroke patients presenting with a stiff knee gait.
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:
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.

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.

Primary study parameters/outcome of the study:
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.

Secundary study parameters/outcome of the study:
Stroke Impact Scale (SIS)

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
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.
- Main changes (audit trail)
- RECORD18-jan-2010 - 29-jan-2010


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