Spastic Equinovarus FootPhase 3NeurotomyNCT00825097
Efficacy Study of Selective Tibial Neurotomy in the Treatment of the Spastic Equinovarus Foot Among Adult Hemiplegic Patients
A Phase 3 study testing Selective tibial neurotomy and Botulinum toxin injection in people with Spastic Equinovarus Foot and Stroke, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Spastic equinovarus foot (SEF) is a major cause of disability in stroke patients. Treatments may include physical therapy, orthosis, botulinum toxin (BTX) injections and selective neurotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spastic Equinovarus Foot, Stroke
- What is being tested?
- Selective tibial neurotomy and Botulinum toxin injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2008to Dec 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic stroke patients (more than 6 months after stroke)
- SEF due to spasticity of the calf muscles
- Positive effects of lidocaïne selective motor nerve block
- No associated tendinosous retraction: ankle dorsiflexion ≥ 0°after block
- Insufficient benefit of adaptated kinesitherapy
- Gait ability allowing an instrumented gait analysis
Who cannot join
- Pregnant women
- BTX injection in the lower limb during the 6 months before inclusion
- BTX injection in another limb during the 6 months before inclusion
- patients unable to walk without orthosis on a treadmill
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Université Catholique de Louvain - Cliniques universitaires Saint-Luc
Brussels, 1200
About this study
Official title: Study of the Efficacy of the Selective Neurotomy in the Treatment of the Spastic Equinovarus Foot Among Adult Hemiplegic Patient Following the ICF Model. A Prospective, Randomized, Controlled Single Blind Study
Spastic equinovarus foot (SEF) is a major cause of disability in stroke patients. Treatments may include physical therapy, orthosis, botulinum toxin (BTX) injections and selective neurotomy.
Several RCT placebo-controlled studies have demonstrated improvement in spasticity, in pain and in active ankle dorsiflexion after BTX injections.
Read more
Unfortunately, BTX is an expensive treatment and its effects last about three months.
Selective neurotomy consists in a partial section of the motor nerve innervating spastic muscles responsible for the SEF, leading to a permanent treatment of the SEF.
Until now, neurotomy has only been assessed by observational case-report studies and has never been submitted to a RCT.
The aim of our study is to evaluate the benefits of selective tibial neurotomy in case of SEF according to the 3 domains of the ICF, by comparing it with BTX injections, among a prospective, randomized, controlled single blind study: it would allow to promote a permanent and cost-effective treatment in case of SEF.
Read the detailed description
INTRODUCTION
Stroke is the third cause of death and the leading cause of handicap among industrialized countries (1). Spasticity following stroke is responsible for spastic equinovarus foot (SEF) in 18% of cases (2). Spastic equinovarus foot is due to spasticity (muscle hypertonia) of the calf muscles (soleus, gastrocnemius and tibialis posterior), often complicated by contracture and by the weakness of peroneus longus and peroneus brevis muscles (3). Therefore, stroke patients walk slowly, and often require assistive device as orthosis or canes. This disability limits their social participation and their quality of life.
Spastic equinovarus foot treatments include oral medications, physical therapy, orthosis, chemical denervations (botulinum toxin, alcohol or phenol injections), selective neurotomy and orthopedic surgery (4, 5). Intra-muscular botulinum toxin injection induces a chemical denervation reducing spasticity of injected muscles. Functional block of the neuromuscular junction due to botulinum toxin is reversible and lasts about 3 months. Therefore, this expensive treatment must regularly be administered, with a risk of antibodies development. Selective neurotomy is a neurosurgical procedure consisting in partially and selectively cutting motor branches innervating the spastic muscles. For a low cost, it can permanently reduce muscle spasticity.
Botulinum toxin injection effectiveness has largely been demonstrated in spastic equinovarus foot treatment by double-blind randomised controlled trials against placebo (6, 7, 8). Selective tibial nerve neurotomy effectiveness has only been suggested in spastic equinovarus foot treatment by uncontrolled and unrandomised case reports (9, 10, 11).
International Classification of Functioning, Disability and Health (ICF) of the World Health Organisation (www.who.int / icidh, 2001) is the framework of the Physical and Rehabilitation Medicine (12). This model describes how a disease can influence patient impairments, activity and participation. Spastic equinovarus foot treatments have already been evaluated in the impairments field: spasticity, muscle strength, walking parameters and gait analysis variables. These treatments should also demonstrate their effectiveness on the patient activity (disability) and on his participation (quality of life).
OBJECTIVES
The aim of the present project is to study the effectiveness of selective tibial nerve neurotomy on the spastic equinovarus foot, by comparing it with botulinum toxin injection. The functional assessment will explore the three ICF domains.
METHODS
We will recruit 20 chronic stroke patients presenting with spastic equinovarus foot. This spastic equinovarus foot will be due to calf muscles spasticity without contracture. This spasticity will not have been managed effectively by physical therapy.
First, a lidocaïne selective diagnostic motor branch block will systematically be carried out to confirm the treatment indication, and to determine the muscles and / or nerves to treat (14). Once the muscles responsible for the spastic equinovarus foot will be identified, they will surgically or chemically be denervated.
Than, patients will be randomized in two groups:
- One group receiving botulinum toxin injections (toxin group).
- One group undergoing a neurotomy (neurotomy group).
Patients will be assessed before treatment, 2 months and 6 months after treatment among the 3 ICF domains. Impairments will be assessed by the Stoke Impairment Assessment Set (SIAS), the Ashworth and Tardieu scales (spasticity) and the MRC scale (muscle strength). Spasticity and gait disorders will quantitatively and objectively be evaluated by the muscle stiffness measurement (15) and an instrumented gait analysis (11). Disability will be evaluated by the ABILOCO scale (16) and the participation (quality of life) by the StrokeQol scale (17) and the SF-36 questionnaire.
The patients selection, the lidocaïne hyperselective diagnostic blocks, the botulinum toxin injections and the selective neurotomies will be achieved at Cliniques universitaires Mont-Godinne. The functional assessment (clinical evaluation, gait analysis, muscle stiffness measurement) will be achieved in the Physical Medicine and Rehabilitation department (READ unit) by a blinded assessor.
PERSPECTIVE
From this study, we hope to demonstrate the effectiveness of the selective neurotomy in spastic equinovarus foot treatment among the 3 ICF domains (impairment, activity and participation). This should promote this effective, permanent and cheap spastic equinovarus foot treatment.
- Conditions
- Spastic Equinovarus Foot, Stroke
- Being tested
- Selective tibial neurotomy, Botulinum toxin injection
- Keywords
- Spastic equinovarus foot, Stroke, Tibial neurotomy, Botulinum toxin type A, Selective tibial neurotomy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective tibial neurotomyProcedure or surgery
Selective tibial neurotomy is a neurosurgical intervention consisting in partially and selectively cutting the motor nerve branches destinated to the spastic muscles.
Botulinum toxin injectionDrug
Botulinum toxin type A
| Study group | Role | What they receive |
|---|---|---|
| Neurotomy Group | Experimental | 8 patients undergoing a selective tibial neurotomy under general anesthesia Receives: Procedure: Selective tibial neurotomy |
| BTX Group | Active comparator | 8 patients undergoing a botulinum toxin injection in the calf muscles under EMG-control Receives: Drug: Botulinum toxin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impairments:SIAS,Ashworth and Tardieu scales and MRC scale. Spasticity and gait disorders:muscle stiffness measurement (15) and instrumented gait analysis (11). Disability: ABILOCO scale (16). Participation (quality of life)
Measured: Before treatment (T0); 2 months (T1) and six months (T2) after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startOct 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Spastic Equinovarus FootStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique
- Responsible party
- Principal investigator, Lejeune, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Investigators
- Benjamin Bollens, Doctor, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825097
- Sponsor's protocol ID
- READ-Bollens-01
- Acronym
- Neurotomy
- Status last verified
- Dec 2011
- First submitted
- 14 Nov 2008
- Last updated
- 23 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jorgensen HS, Nakayama H, Raaschou HO, Olsen TS. Recovery of walking function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995 Jan;76(1):27-32. doi: 10.1016/s0003-9993(95)80038-7.
PubMed 7811170Verdie C, Daviet JC, Borie MJ, Popielarz S, Munoz M, Salle JY, Rebeyrotte I, Dudognon P. [Epidemiology of pes varus and/or equinus one year after a first cerebral hemisphere stroke: apropos of a cohort of 86 patients]. Ann Readapt Med Phys. 2004 Mar;47(2):81-6. doi: 10.1016/j.annrmp.2003.10.005. French.
PubMed 15013602Burridge JH, Wood DE, Taylor PN, McLellan DL. Indices to describe different muscle activation patterns, identified during treadmill walking, in people with spastic drop-foot. Med Eng Phys. 2001 Jul;23(6):427-34. doi: 10.1016/s1350-4533(01)00061-3.
PubMed 11551819Burbaud P, Wiart L, Dubos JL, Gaujard E, Debelleix X, Joseph PA, Mazaux JM, Bioulac B, Barat M, Lagueny A. A randomised, double blind, placebo controlled trial of botulinum toxin in the treatment of spastic foot in hemiparetic patients. J Neurol Neurosurg Psychiatry. 1996 Sep;61(3):265-9. doi: 10.1136/jnnp.61.3.265.
PubMed 8795597Pittock SJ, Moore AP, Hardiman O, Ehler E, Kovac M, Bojakowski J, Al Khawaja I, Brozman M, Kanovsky P, Skorometz A, Slawek J, Reichel G, Stenner A, Timerbaeva S, Stelmasiak Z, Zifko UA, Bhakta B, Coxon E. A double-blind randomised placebo-controlled evaluation of three doses of botulinum toxin type A (Dysport) in the treatment of spastic equinovarus deformity after stroke. Cerebrovasc Dis. 2003;15(4):289-300. doi: 10.1159/000069495.
PubMed 12686794Mancini F, Sandrini G, Moglia A, Nappi G, Pacchetti C. A randomised, double-blind, dose-ranging study to evaluate efficacy and safety of three doses of botulinum toxin type A (Botox) for the treatment of spastic foot. Neurol Sci. 2005 Apr;26(1):26-31. doi: 10.1007/s10072-005-0378-9.
PubMed 15877184Decq P, Filipetti P, Cubillos A, Slavov V, Lefaucheur JP, Nguyen JP. Soleus neurotomy for treatment of the spastic equinus foot. Groupe d'Evaluation et de Traitement de la Spasticite et de la Dystonie. Neurosurgery. 2000 Nov;47(5):1154-60; discussion 1160-1. doi: 10.1097/00006123-200011000-00027.
PubMed 11063109Buffenoir K, Roujeau T, Lapierre F, Menei P, Menegalli-Boggelli D, Mertens P, Decq P. Spastic equinus foot: multicenter study of the long-term results of tibial neurotomy. Neurosurgery. 2004 Nov;55(5):1130-7. doi: 10.1227/01.neu.0000140840.59586.cf.
PubMed 15509319Deltombe T, Detrembleur C, Hanson P, Gustin T. Selective tibial neurotomy in the treatment of spastic equinovarus foot: a 2-year follow-up of three cases. Am J Phys Med Rehabil. 2006 Jan;85(1):82-8. doi: 10.1097/01.phm.0000193506.70371.cf.
PubMed 16357553Stucki G. International Classification of Functioning, Disability, and Health (ICF): a promising framework and classification for rehabilitation medicine. Am J Phys Med Rehabil. 2005 Oct;84(10):733-40. doi: 10.1097/01.phm.0000179521.70639.83. No abstract available.
PubMed 16205428Stoquart GG, Detrembleur C, Palumbo S, Deltombe T, Lejeune TM. Effect of botulinum toxin injection in the rectus femoris on stiff-knee gait in people with stroke: a prospective observational study. Arch Phys Med Rehabil. 2008 Jan;89(1):56-61. doi: 10.1016/j.apmr.2007.08.131.
PubMed 18164331Deltombe T, De Wispelaere JF, Gustin T, Jamart J, Hanson P. Selective blocks of the motor nerve branches to the soleus and tibialis posterior muscles in the management of the spastic equinovarus foot. Arch Phys Med Rehabil. 2004 Jan;85(1):54-8. doi: 10.1016/s0003-9993(03)00405-2.
PubMed 14970968Detrembleur C, Lejeune TM, Plaghki L. [Objective measures of muscle stiffness in the ankle. Evaluation of the effect of intrathecal injection of baclofen in spastic patients]. Neurochirurgie. 1998 Sep;44(3):197-200. French.
PubMed 9827436Caty GD, Arnould C, Stoquart GG, Thonnard JL, Lejeune TM. ABILOCO: a Rasch-built 13-item questionnaire to assess locomotion ability in stroke patients. Arch Phys Med Rehabil. 2008 Feb;89(2):284-90. doi: 10.1016/j.apmr.2007.08.155.
PubMed 18226652
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy of the Selective Neurotomy in the Treatment of the Spastic Equinovarus Foot Among Adult Hemiplegic Patient Following the ICF Model. A Prospective, Randomized, Controlled Single Blind Study
- ClinicalTrials.gov ID
- NCT00825097
- Acronym / sponsor ID
- Neurotomy / READ-Bollens-01
- Conditions
- Spastic Equinovarus Foot, Stroke
- Keywords
- Spastic equinovarus foot, Stroke, Tibial neurotomy, Botulinum toxin type A, Selective tibial neurotomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique
- Study start
- Oct 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Spastic equinovarus foot (SEF) is a major cause of disability in stroke patients. Treatments may include physical therapy, orthosis, botulinum toxin (BTX) injections and selective neurotomy.
Several RCT placebo-controlled studies have demonstrated improvement in spasticity, in pain and in active ankle dorsiflexion after BTX injections.
Unfortunately, BTX is an expensive treatment and its effects last about three months.
Selective neurotomy consists in a partial section of the motor nerve innervating spastic muscles responsible for the SEF, leading to a permanent treatment of the SEF.
Until now, neurotomy has only been assessed by observational case-report studies and has never been submitted to a RCT.
The aim of our study is to evaluate the benefits of selective tibial neurotomy in case of SEF according to the 3 domains of the ICF, by comparing it with BTX injections, among a prospective, randomized, controlled single blind study: it would allow to promote a permanent and cost-effective treatment in case of SEF.
Detailed description
INTRODUCTION
Stroke is the third cause of death and the leading cause of handicap among industrialized countries (1). Spasticity following stroke is responsible for spastic equinovarus foot (SEF) in 18% of cases (2). Spastic equinovarus foot is due to spasticity (muscle hypertonia) of the calf muscles (soleus, gastrocnemius and tibialis posterior), often complicated by contracture and by the weakness of peroneus longus and peroneus brevis muscles (3). Therefore, stroke patients walk slowly, and often require assistive device as orthosis or canes. This disability limits their social participation and their quality of life.
Spastic equinovarus foot treatments include oral medications, physical therapy, orthosis, chemical denervations (botulinum toxin, alcohol or phenol injections), selective neurotomy and orthopedic surgery (4, 5). Intra-muscular botulinum toxin injection induces a chemical denervation reducing spasticity of injected muscles. Functional block of the neuromuscular junction due to botulinum toxin is reversible and lasts about 3 months. Therefore, this expensive treatment must regularly be administered, with a risk of antibodies development. Selective neurotomy is a neurosurgical procedure consisting in partially and selectively cutting motor branches innervating the spastic muscles. For a low cost, it can permanently reduce muscle spasticity.
Botulinum toxin injection effectiveness has largely been demonstrated in spastic equinovarus foot treatment by double-blind randomised controlled trials against placebo (6, 7, 8). Selective tibial nerve neurotomy effectiveness has only been suggested in spastic equinovarus foot treatment by uncontrolled and unrandomised case reports (9, 10, 11).
International Classification of Functioning, Disability and Health (ICF) of the World Health Organisation (www.who.int / icidh, 2001) is the framework of the Physical and Rehabilitation Medicine (12). This model describes how a disease can influence patient impairments, activity and participation. Spastic equinovarus foot treatments have already been evaluated in the impairments field: spasticity, muscle strength, walking parameters and gait analysis variables. These treatments should also demonstrate their effectiveness on the patient activity (disability) and on his participation (quality of life).
OBJECTIVES
The aim of the present project is to study the effectiveness of selective tibial nerve neurotomy on the spastic equinovarus foot, by comparing it with botulinum toxin injection. The functional assessment will explore the three ICF domains.
METHODS
We will recruit 20 chronic stroke patients presenting with spastic equinovarus foot. This spastic equinovarus foot will be due to calf muscles spasticity without contracture. This spasticity will not have been managed effectively by physical therapy.
First, a lidocaïne selective diagnostic motor branch block will systematically be carried out to confirm the treatment indication, and to determine the muscles and / or nerves to treat (14). Once the muscles responsible for the spastic equinovarus foot will be identified, they will surgically or chemically be denervated.
Than, patients will be randomized in two groups:
- One group receiving botulinum toxin injections (toxin group).
- One group undergoing a neurotomy (neurotomy group).
Patients will be assessed before treatment, 2 months and 6 months after treatment among the 3 ICF domains. Impairments will be assessed by the Stoke Impairment Assessment Set (SIAS), the Ashworth and Tardieu scales (spasticity) and the MRC scale (muscle strength). Spasticity and gait disorders will quantitatively and objectively be evaluated by the muscle stiffness measurement (15) and an instrumented gait analysis (11). Disability will be evaluated by the ABILOCO scale (16) and the participation (quality of life) by the StrokeQol scale (17) and the SF-36 questionnaire.
The patients selection, the lidocaïne hyperselective diagnostic blocks, the botulinum toxin injections and the selective neurotomies will be achieved at Cliniques universitaires Mont-Godinne. The functional assessment (clinical evaluation, gait analysis, muscle stiffness measurement) will be achieved in the Physical Medicine and Rehabilitation department (READ unit) by a blinded assessor.
PERSPECTIVE
From this study, we hope to demonstrate the effectiveness of the selective neurotomy in spastic equinovarus foot treatment among the 3 ICF domains (impairment, activity and participation). This should promote this effective, permanent and cheap spastic equinovarus foot treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurotomy Group | Experimental | Procedure: Selective tibial neurotomy8 patients undergoing a selective tibial neurotomy under general anesthesia |
| BTX Group | Active comparator | Drug: Botulinum toxin injection8 patients undergoing a botulinum toxin injection in the calf muscles under EMG-control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic stroke patients (more than 6 months after stroke)
- SEF due to spasticity of the calf muscles
- Positive effects of lidocaïne selective motor nerve block
- No associated tendinosous retraction: ankle dorsiflexion ≥ 0°after block
- Insufficient benefit of adaptated kinesitherapy
Key exclusion criteria (4 listed)
- Pregnant women
- BTX injection in the lower limb during the 6 months before inclusion
- BTX injection in another limb during the 6 months before inclusion
- patients unable to walk without orthosis on a treadmill
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective tibial neurotomySelective tibial neurotomy is a neurosurgical intervention consisting in partially and selectively cutting the motor nerve branches destinated to the spastic muscles. | Procedure or surgery | Neurotomy Group |
| Botulinum toxin injectionBotulinum toxin type A | Drug | BTX Group |
Primary outcome
Impairments:SIAS,Ashworth and Tardieu scales and MRC scale. Spasticity and gait disorders:muscle stiffness measurement (15) and instrumented gait analysis (11). Disability: ABILOCO scale (16). Participation (quality of life)
Time frame: Before treatment (T0); 2 months (T1) and six months (T2) after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2011.
- Background: PubMed 7811170Jorgensen HS, Nakayama H, Raaschou HO, Olsen TS. Recovery of walking function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995 Jan;76(1):27-32. doi: 10.1016/s0003-9993(95)80038-7.
- Background: PubMed 15013602Verdie C, Daviet JC, Borie MJ, Popielarz S, Munoz M, Salle JY, Rebeyrotte I, Dudognon P. [Epidemiology of pes varus and/or equinus one year after a first cerebral hemisphere stroke: apropos of a cohort of 86 patients]. Ann Readapt Med Phys. 2004 Mar;47(2):81-6. doi: 10.1016/j.annrmp.2003.10.005. French.
- Background: PubMed 11551819Burridge JH, Wood DE, Taylor PN, McLellan DL. Indices to describe different muscle activation patterns, identified during treadmill walking, in people with spastic drop-foot. Med Eng Phys. 2001 Jul;23(6):427-34. doi: 10.1016/s1350-4533(01)00061-3.
- Background: PubMed 8795597Burbaud P, Wiart L, Dubos JL, Gaujard E, Debelleix X, Joseph PA, Mazaux JM, Bioulac B, Barat M, Lagueny A. A randomised, double blind, placebo controlled trial of botulinum toxin in the treatment of spastic foot in hemiparetic patients. J Neurol Neurosurg Psychiatry. 1996 Sep;61(3):265-9. doi: 10.1136/jnnp.61.3.265.
- Background: PubMed 12686794Pittock SJ, Moore AP, Hardiman O, Ehler E, Kovac M, Bojakowski J, Al Khawaja I, Brozman M, Kanovsky P, Skorometz A, Slawek J, Reichel G, Stenner A, Timerbaeva S, Stelmasiak Z, Zifko UA, Bhakta B, Coxon E. A double-blind randomised placebo-controlled evaluation of three doses of botulinum toxin type A (Dysport) in the treatment of spastic equinovarus deformity after stroke. Cerebrovasc Dis. 2003;15(4):289-300. doi: 10.1159/000069495.
- Background: PubMed 15877184Mancini F, Sandrini G, Moglia A, Nappi G, Pacchetti C. A randomised, double-blind, dose-ranging study to evaluate efficacy and safety of three doses of botulinum toxin type A (Botox) for the treatment of spastic foot. Neurol Sci. 2005 Apr;26(1):26-31. doi: 10.1007/s10072-005-0378-9.
- Background: PubMed 11063109Decq P, Filipetti P, Cubillos A, Slavov V, Lefaucheur JP, Nguyen JP. Soleus neurotomy for treatment of the spastic equinus foot. Groupe d'Evaluation et de Traitement de la Spasticite et de la Dystonie. Neurosurgery. 2000 Nov;47(5):1154-60; discussion 1160-1. doi: 10.1097/00006123-200011000-00027.
- Background: PubMed 15509319Buffenoir K, Roujeau T, Lapierre F, Menei P, Menegalli-Boggelli D, Mertens P, Decq P. Spastic equinus foot: multicenter study of the long-term results of tibial neurotomy. Neurosurgery. 2004 Nov;55(5):1130-7. doi: 10.1227/01.neu.0000140840.59586.cf.
- Background: PubMed 16357553Deltombe T, Detrembleur C, Hanson P, Gustin T. Selective tibial neurotomy in the treatment of spastic equinovarus foot: a 2-year follow-up of three cases. Am J Phys Med Rehabil. 2006 Jan;85(1):82-8. doi: 10.1097/01.phm.0000193506.70371.cf.
- Background: PubMed 16205428Stucki G. International Classification of Functioning, Disability, and Health (ICF): a promising framework and classification for rehabilitation medicine. Am J Phys Med Rehabil. 2005 Oct;84(10):733-40. doi: 10.1097/01.phm.0000179521.70639.83. No abstract available.
- Background: PubMed 18164331Stoquart GG, Detrembleur C, Palumbo S, Deltombe T, Lejeune TM. Effect of botulinum toxin injection in the rectus femoris on stiff-knee gait in people with stroke: a prospective observational study. Arch Phys Med Rehabil. 2008 Jan;89(1):56-61. doi: 10.1016/j.apmr.2007.08.131.
- Background: PubMed 14970968Deltombe T, De Wispelaere JF, Gustin T, Jamart J, Hanson P. Selective blocks of the motor nerve branches to the soleus and tibialis posterior muscles in the management of the spastic equinovarus foot. Arch Phys Med Rehabil. 2004 Jan;85(1):54-8. doi: 10.1016/s0003-9993(03)00405-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Bollens, Doctor principal investigator
Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Selective tibial neurotomy and Botulinum toxin injection in people with Spastic Equinovarus Foot and Stroke, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impairments:SIAS,Ashworth and Tardieu scales and MRC scale. Spasticity and gait disorders:muscle stiffness measurement (15) and instrumented gait analysis (11). Disability: ABILOCO scale (16). Participation (quality of life) (time frame: Before treatment (T0); 2 months (T1) and six months (T2) after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00825097, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2011.