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Clinical randomized clinical trial to assess the effectiveness on walking speed of repeated use of botulinum neurotoxin type A (BoNT/A)in the post-stroke spastic equinovarus foot in three successive infiltrations at 6-month intervals, checking if the sustainability of the effect is greater in incobotulinumtoxin A (Xeomin®) than in onabotulinumtoxinA (Botox®).
Spasticity is present in 38% of patients at six months after stroke. Equinovarus foot, with or without claw toes and striatal foot, is especially common. There is a weak to moderate evidence in favor of the use of botulinum neurotoxin type A (BoNT/A) in the equinovarus foot, stiff-knee and in other patterns that may interfere with gait ability. Specifically, BoNT/A increases walking speed in stroke patients with spastic equinovarus foot.
Repeated use of BoNT/A may lead to the appearance of neutralizing antibodies, so its effect may decrease over successive infiltrations. Among the differential characteristics of incobotulinumtoxinA (Xeomin®) there is a reduced inactivated botulinum neurotoxin content and the lack of complexing proteins, which would diminish antigenicity and not suppose a decrease of the effect before successive infiltrations.
The objective of this project is to determine the effect on walking speed of repeated use of BoNT/A in post-stroke spinal equinovarus foot in three consecutive injections at 6-month intervals and to investigate whether the sustainability of the effect is greater in incobotulinumtoxinA (Xeomin®) than in onabotulinumtoxinA (Botox®). All patients will receive 200-300 units of BoNT/A (Xeomin ® or Botox ®) that will be distributed according to the individual clinical pattern of spastic equinovarus foot.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IncobotulinumtoxinA | Active Comparator | Injection of 200-300 units of IncobotulinumtoxinA (Xeomin ®) |
|
| OnabotulinumtoxinA | Active Comparator | Injection of 200-300 units of onabotulinumtoxiA (Botox®) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IncobotulinumtoxinA | Drug | Three consecutive injections of 200-300 units of IncobotulinumtoxinA (Xeomin ®) under ultrasound guidance. The IncobotulinumtoxinA will be distributed according to the individual clinical pattern of spasticity: plantar flexor muscles (triceps sural: gastrocnemius and soleus), tibialis posterior, flexor digitorum longus. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in walking speed | Walking speed, expressed in m/s, is assessed in a 10-m corridor | Baseline and monthly during 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in spasticity assessed with the Modified Ashworth Scale | Spasticity assessed with the Modified Ashworth Scale (range 0-5) | Baseline and monthly during 18 months |
| Change in walking disability assessed with the Scandinavian Stroke Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esther Duarte, PhD | Fundació IMIM - Parc de Salut Mar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de l'Esperança | Barcelona | 08024 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14684785 | Background | Sommerfeld DK, Eek EU, Svensson AK, Holmqvist LW, von Arbin MH. Spasticity after stroke: its occurrence and association with motor impairments and activity limitations. Stroke. 2004 Jan;35(1):134-9. doi: 10.1161/01.STR.0000105386.05173.5E. Epub 2003 Dec 18. | |
| 12194622 | Background | Watkins CL, Leathley MJ, Gregson JM, Moore AP, Smith TL, Sharma AK. Prevalence of spasticity post stroke. Clin Rehabil. 2002 Aug;16(5):515-22. doi: 10.1191/0269215502cr512oa. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C545476 | incobotulinumtoxinA |
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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Parallel assignment
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Double blind
|
| OnabotulinumtoxinA | Drug | ree consecutive injections of 200-300 units of OnabotulinumtoxinA (Botox ®) under ultrasound guidance. The BoNT/A will be distributed according to the individual clinical pattern of spasticity: plantar flexor muscles (triceps sural: gastrocnemius and soleus), tibialis posterior, flexor digitorum longus. |
|
Walking disability is assessed with the Scandinavian Stroke Scale
| Baseline and monthly during 18 months |
| Change in functional ambulation ability assessed with the Modified Walking Categories | Functional ambulation ability is assessed with the Modified Walking Categories | Baseline and monthly during 18 months |
| Change in step time | Step time (Temporal gait parameter) is expressed in seconds and assessed with instrumented gait analysis | Baseline and monthly during 18 months |
| Change in step length | Step length (Spatial gait parameter) is expressed in meters and assessed with instrumented gait analysis | Baseline and monthly during 18 months |
| 20491885 | Background | Foley N, Murie-Fernandez M, Speechley M, Salter K, Sequeira K, Teasell R. Does the treatment of spastic equinovarus deformity following stroke with botulinum toxin increase gait velocity? A systematic review and meta-analysis. Eur J Neurol. 2010 Dec;17(12):1419-27. doi: 10.1111/j.1468-1331.2010.03084.x. |
| 22035051 | Background | Dressler D. Five-year experience with incobotulinumtoxinA (Xeomin((R)) ): the first botulinum toxin drug free of complexing proteins. Eur J Neurol. 2012 Mar;19(3):385-9. doi: 10.1111/j.1468-1331.2011.03559.x. Epub 2011 Oct 28. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |