Spastic EquinovarusNCT00199589
Treatment of Spastic Equinovarus Foot After Stroke
A study testing Botulinic toxin (Botox) in people with Spastic Equinovarus, run by University Hospital, Limoges at 2 sites in France.
Trial summary
This study evaluates treatment for spastic foot after stroke using ankle foot orthosis with or without selective injection of BTA (Botox). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spastic Equinovarus
- What is being tested?
- Botulinic toxin (Botox)
- Type of treatment
- Injection or infusion
- How many people
- 46 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2002to Dec 2007
- Phase
- Interventional
- 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
- Stroke patient with equinovarus foot due to severe lower limb extensor spasticity with impaired foot contact during walking
- Ability to walk for at least 10 meters with or without aid
- Stroke interval < 12 months
- Age > 18 years old
- Weight > 30 kg and < 100 kg
- Written informed consent
Who cannot join
- Stroke interval > 12 months
- Age < 18 years old
- Pregnancy
- Neuromuscular disease
- Previous treatment with BTA
- Fixed contractures impairing mobility
- Mini-Mental Status Examination < 25
- Aminosides treatment.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Département de Médecine Physique et de Réadaptation
Bordeaux
Département de Médecine Physique et de Réadaptation, CHU Limoges
Limoges
About this study
Official title: Treatment of Spastic Equinovarus Foot After Stroke. Efficacy: Association Between Ankle Foot Orthosis and Botulinum Toxin A (BTA) Injection
This study evaluates treatment for spastic foot after stroke using ankle foot orthosis with or without selective injection of BTA (Botox).
Read the detailed description
This prospective, multicentric open trial evaluates the efficacy of a combined treatment for spastic foot after stroke using ankle foot orthosis with or without selective injection of BTA (Botox) into the tibialis anterior and/or posterior and/or the long toe flexor, and/or medial and lateral gastrocnemius, and/or soleus muscles [300 BTA U per injection (Botox - Allergan), diluted with saline to a concentration of 5U/0,1 mL, with electromyography guided injection]. The patients are followed for one year after treatment.
- Conditions
- Spastic Equinovarus
- Being tested
- Botulinic toxin (Botox)
- Keywords
- Spastic equinovarus, Botox, Ankle foot orthosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinic toxin (Botox)Drug
Patients may benefit, depending on the draw, in addition to their orthosis, intramuscular injections of botulinum toxin.These injections are among 6 in the muscles posterior (rear) of the leg paralyzed with tracking electromyographic to ensure the accuracy of the injection.
What is being measured
The primary outcome is the main question the study is designed to answer.
Plantar contact during walking
Secondary outcomes (6)
Gait velocity
Barthel index
MIF
Autosatisfaction by EVA
Asworth scale
Ankle range of motion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startOct 2002
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic EquinovarusStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Investigators
- Jean-Yves Salle, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199589
- Sponsor's protocol ID
- I01014
- Status last verified
- Dec 2008
- First submitted
- 14 Sep 2005
- Last updated
- 30 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Spastic Equinovarus Foot After Stroke. Efficacy: Association Between Ankle Foot Orthosis and Botulinum Toxin A (BTA) Injection
- ClinicalTrials.gov ID
- NCT00199589
- Acronym / sponsor ID
- I01014
- Conditions
- Spastic Equinovarus
- Keywords
- Spastic equinovarus, Botox, Ankle foot orthosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Oct 2002
- Study completion
- Dec 2007 (actual)
- First posted
- 20 Sep 2005 (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.
This study evaluates treatment for spastic foot after stroke using ankle foot orthosis with or without selective injection of BTA (Botox).
Detailed description
This prospective, multicentric open trial evaluates the efficacy of a combined treatment for spastic foot after stroke using ankle foot orthosis with or without selective injection of BTA (Botox) into the tibialis anterior and/or posterior and/or the long toe flexor, and/or medial and lateral gastrocnemius, and/or soleus muscles [300 BTA U per injection (Botox - Allergan), diluted with saline to a concentration of 5U/0,1 mL, with electromyography guided injection]. The patients are followed for one year after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stroke patient with equinovarus foot due to severe lower limb extensor spasticity with impaired foot contact during walking
- Ability to walk for at least 10 meters with or without aid
- Stroke interval < 12 months
- Age > 18 years old
- Weight > 30 kg and < 100 kg
Key exclusion criteria (8 listed)
- Stroke interval > 12 months
- Age < 18 years old
- Pregnancy
- Neuromuscular disease
- Previous treatment with BTA
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 |
|---|---|---|
| Botulinic toxin (Botox)Patients may benefit, depending on the draw, in addition to their orthosis, intramuscular injections of botulinum toxin.These injections are among 6 in the muscles posterior (rear) of the leg paralyzed with tracking electromyographic to ensure the accuracy of the injection. | Drug | – |
Primary outcome
Plantar contact during walking
6 secondary outcomes
Gait velocity
Barthel index
MIF
Autosatisfaction by EVA
Asworth scale
Ankle range of motion
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 30 Dec 2008.
Related trials for Spastic Equinovarus
Active, not recruiting
Efficacy of Focused Shock Wave Therapy Before and After Botulinum Toxin Injection in Patients With Post-Stroke Spastic Equinus/Equinovarus Foot: A Randomized Clinical Trial
Post-Stroke Spasticity, Spastic Equinovarus Foot
Recruiting
Pilot Study on Muscle, Tendon, and Neural Changes Post-Botulinum Toxin Injections in Post-stroke Spastic Equinovarus
Stroke, Spasticity
Recruiting
Evaluation of Percutaneous Cryoneurotomy Compared to Surgical Open Neurotomy for the Management of Equinovarus Foot Deformity in Patients With Refractory Lower Limb Spasticity After Stroke
Stroke, Equinovarus Foot
Not yet recruiting
Improving STEP in Stroke Patients
Stroke, Hemiplegia Following Ischemic Stroke
Recruiting
To Evaluate the Efficiency and Results of Adding BFR to the Physical Therapy Program fo Managing Adolescents Presented With Spasmotic Flatfoot Deformities Compared to the Standard Physical Therapy Program Without BFR
Flat Foot; Spastic
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.
Jean-Yves Salle, MD principal investigator
University Hospital, Limoges
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinic toxin (Botox) in people with Spastic Equinovarus, run by University Hospital, Limoges at 2 sites in France.
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 8 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 30 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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.
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?
Plantar contact during walking. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2008.