Spastic Equinovarus FootNCT03405948
Efficiency of Botulinum Toxin Injection for Spastic Equinovarus Foot in Post Stroke Hemiparetic Patients
A study testing Intra muscular injection of Botulinum toxin in people with Spastic Equinovarus Foot, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Botulinum toxin is the main treatment for focal spasticity but the effects of botulinum toxin injections with respect to limitations of gait activities are still discussed. The aim of this study is to to investigate the effects of intramuscular Botulinum toxin type A injections on quantitative gait parameters (gait… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spastic Equinovarus Foot
- What is being tested?
- Intra muscular injection of Botulinum toxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 19 May 2006to 17 Nov 2010
- 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
- Chronic stroke hemiplegic patients presenting lower limb spasticity
- A minimum 12-month interval since stroke,
- Lower limb spasticity with a Modified Ashworth Scale greater than or equal to 2 on the triceps surae
- Minimum 6-month interval since a previous BTx-A injection
- To be older than 18 years.
- Patients must have an indication of treatment with Botulinum toxin, determined by a Physical and Rehabilitation Medicine specialist, based on clinical examination and gait analysis
Who cannot join
- Contraindication to the use of botulinum toxin: Myastenia, Lambert Eaton syndrome, ALS, pregnancy, breast-feeding, treatment with aminoglycoside, cyclosporine, previous hypersensitivity to botulinum toxin
- Contraindication to intramuscular injections
- Patients unable to give consent
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital de la Timone Assistance Publique Hôpitaux de Marseille
Marseille, 13354
About this study
Official title: Efficiency of Botulinum Toxin Injection for Spastic Equinovarus Foot in Post Stroke Hemiparetic Patients Randomized Controlled Trial Versus Placebo
Botulinum toxin is the main treatment for focal spasticity but the effects of botulinum toxin injections with respect to limitations of gait activities are still discussed. The aim of this study is to to investigate the effects of intramuscular Botulinum toxin type A injections on quantitative gait parameters (gait speed, step length and width, single support time) and posture, in hemiparetic post stroke patients with lower limb spasticity.
Read the detailed description
Multicenter, randomized, active treatment versus placebo, double-blind trial.
Hemiplegia by stroke is the leading cause of disability in adults in France (145 new cases per 100 000 population), a source of locomotor disabilities. The spastic equinovarus foot is the main cause of standing and walking disorders in these patients. Current therapies rely mainly on rehabilitation and equipment care, or for some on surgery. Botulinum toxin A is more and more used in this context. Two randomized studies (double-blind, placebo-controlled) have already demonstrated efficacy in terms of impairment (spasticity assessed using the Ashworth scale), but not in terms of capacity (evaluated from walking speed). ). The ability to maintain standing balance during an attention task and during walking, the study of quality of life have never been studied. But these parameters are important in the approach of the evaluation of such a therapy.
The purpose of the research is to evaluate the efficacy of botulinum toxin A in the treatment of adult post-stroke spastic equine varus foot in terms of: ability to maintain upright balance during an attentional task (main objective), coordination of posture and movement, standing posture, impairments and abilities, or quality of life (secondary objectives). To evaluate the tolerance and the undesirable effects related to the use of the toxin.
Methodology Prospective, comparative and randomized study, active product (botulinum toxin A) versus placebo. Patients will be recruited from the functional rehabilitation clinic. After verification of the inclusion criteria, the pre-therapeutic evaluation will be organized including: double spots, coordination posture and movement, standing posture, deficiencies and abilities, quality of life. The doctor will schedule the therapeutic session within 2 weeks. A second post-treatment evaluation will be carried out at the 4th week of follow-up according to the same scheme. The number of subjects required has been set at 84.
Method Clinical evaluation, posture and gait analysis were performed before injection and 4 to 6 weeks after injection. Quantitative gait parameters (gait speed, step length and width, single support time) were recorded with the Gaitrite walking mat. Posture was recorded with AMTI® forceplate.
Expected results: demonstrate the effectiveness of botulinum toxin on gait and balance First study about effects of botulinum toxin injection on gait parameters registered by a walking mat and objective measure of posture in dual task condition in chronic post stroke patients
- Conditions
- Spastic Equinovarus Foot
- Being tested
- Intra muscular injection of Botulinum toxin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra muscular injection of Botulinum toxinDrug
posture and gait analysis were performed before injection and 4 to 6 weeks after injection
| Study group | Role | What they receive |
|---|---|---|
| botulinum toxin | Experimental | injection of Botulinum toxin Receives: Drug: Intra muscular injection of Botulinum toxin |
| placebo | Placebo comparator | Injection of saline serum (placebo) Receives: Drug: Intra muscular injection of Botulinum toxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posture
sway area of the center of pressure measured with AMTI® force plate
Measured: 6 weeks after injection
Secondary outcomes (1)
Gait
Walking speed measured with Gaitrite® walking mat
Measured: 6 weeks after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start19 May 2006
- Primary completion18 May 2009
- Study completion17 Nov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Assistance Publique Hopitaux De MarseilleThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique des Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405948
- Sponsor's protocol ID
- 2005-21
- Status last verified
- Oct 2017
- First submitted
- 31 Oct 2017
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kerzoncuf M, Viton JM, Pellas F, Cotinat M, Calmels P, Milhe de Bovis V, Delarque A, Bensoussan L. Poststroke Postural Sway Improved by Botulinum Toxin: A Multicenter Randomized Double-blind Controlled Trial. Arch Phys Med Rehabil. 2020 Feb;101(2):242-248. doi: 10.1016/j.apmr.2019.04.024. Epub 2019 Aug 27.
PubMed 31469982
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Botulinum Toxin Injection for Spastic Equinovarus Foot in Post Stroke Hemiparetic Patients Randomized Controlled Trial Versus Placebo
- ClinicalTrials.gov ID
- NCT03405948
- Acronym / sponsor ID
- 2005-21
- Conditions
- Spastic Equinovarus Foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 19 May 2006 (actual)
- Primary completion
- 18 May 2009 (actual)
- Study completion
- 17 Nov 2010 (actual)
- First posted
- 23 Jan 2018 (actual)
- 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.
Botulinum toxin is the main treatment for focal spasticity but the effects of botulinum toxin injections with respect to limitations of gait activities are still discussed. The aim of this study is to to investigate the effects of intramuscular Botulinum toxin type A injections on quantitative gait parameters (gait speed, step length and width, single support time) and posture, in hemiparetic post stroke patients with lower limb spasticity.
Detailed description
Multicenter, randomized, active treatment versus placebo, double-blind trial.
Hemiplegia by stroke is the leading cause of disability in adults in France (145 new cases per 100 000 population), a source of locomotor disabilities. The spastic equinovarus foot is the main cause of standing and walking disorders in these patients. Current therapies rely mainly on rehabilitation and equipment care, or for some on surgery. Botulinum toxin A is more and more used in this context. Two randomized studies (double-blind, placebo-controlled) have already demonstrated efficacy in terms of impairment (spasticity assessed using the Ashworth scale), but not in terms of capacity (evaluated from walking speed). ). The ability to maintain standing balance during an attention task and during walking, the study of quality of life have never been studied. But these parameters are important in the approach of the evaluation of such a therapy.
The purpose of the research is to evaluate the efficacy of botulinum toxin A in the treatment of adult post-stroke spastic equine varus foot in terms of: ability to maintain upright balance during an attentional task (main objective), coordination of posture and movement, standing posture, impairments and abilities, or quality of life (secondary objectives). To evaluate the tolerance and the undesirable effects related to the use of the toxin.
Methodology Prospective, comparative and randomized study, active product (botulinum toxin A) versus placebo. Patients will be recruited from the functional rehabilitation clinic. After verification of the inclusion criteria, the pre-therapeutic evaluation will be organized including: double spots, coordination posture and movement, standing posture, deficiencies and abilities, quality of life. The doctor will schedule the therapeutic session within 2 weeks. A second post-treatment evaluation will be carried out at the 4th week of follow-up according to the same scheme. The number of subjects required has been set at 84.
Method Clinical evaluation, posture and gait analysis were performed before injection and 4 to 6 weeks after injection. Quantitative gait parameters (gait speed, step length and width, single support time) were recorded with the Gaitrite walking mat. Posture was recorded with AMTI® forceplate.
Expected results: demonstrate the effectiveness of botulinum toxin on gait and balance First study about effects of botulinum toxin injection on gait parameters registered by a walking mat and objective measure of posture in dual task condition in chronic post stroke patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| botulinum toxin | Experimental | Drug: Intra muscular injection of Botulinum toxininjection of Botulinum toxin |
| placebo | Placebo comparator | Drug: Intra muscular injection of Botulinum toxinInjection of saline serum (placebo) |
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 hemiplegic patients presenting lower limb spasticity
- A minimum 12-month interval since stroke,
- Lower limb spasticity with a Modified Ashworth Scale greater than or equal to 2 on the triceps surae
- Minimum 6-month interval since a previous BTx-A injection
- To be older than 18 years.
Key exclusion criteria (3 listed)
- Contraindication to the use of botulinum toxin: Myastenia, Lambert Eaton syndrome, ALS, pregnancy, breast-feeding, treatment with aminoglycoside, cyclosporine, previous hypersensitivity to botulinum toxin
- Contraindication to intramuscular injections
- Patients unable to give consent
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 |
|---|---|---|
| Intra muscular injection of Botulinum toxinposture and gait analysis were performed before injection and 4 to 6 weeks after injection | Drug | botulinum toxin, placebo |
Primary outcome
Posture
Time frame: 6 weeks after injection
sway area of the center of pressure measured with AMTI® force plate
1 secondary outcome
Gait
Time frame: 6 weeks after injection
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 Jan 2018.
- Derived from this study: PubMed 31469982Kerzoncuf M, Viton JM, Pellas F, Cotinat M, Calmels P, Milhe de Bovis V, Delarque A, Bensoussan L. Poststroke Postural Sway Improved by Botulinum Toxin: A Multicenter Randomized Double-blind Controlled Trial. Arch Phys Med Rehabil. 2020 Feb;101(2):242-248. doi: 10.1016/j.apmr.2019.04.024. Epub 2019 Aug 27.
Related trials for Spastic Equinovarus Foot
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Pilot Study on Muscle, Tendon, and Neural Changes Post-Botulinum Toxin Injections in Post-stroke Spastic Equinovarus
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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
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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.
Urielle DESALBRES study director
Assistance Publique des Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra muscular injection of Botulinum toxin in people with Spastic Equinovarus Foot, run by Assistance Publique Hopitaux De Marseille at 1 site 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 3 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 Jan 2018. 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 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. Some participants in this study may receive a placebo. 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?
Posture (time frame: 6 weeks after injection). 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 NCT03405948, which also lists 1 linked publication.
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 Jan 2018.