Botulinum Toxins Injection in Stroke PatientsTRITITOXNCT02699775
Effect of Repeated Botulinum Toxin Injection on Gait Pattern in Stroke Patients
An observational study of Botulinum Toxins Injection in Stroke Patients, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
Chronic stroke patients exhibit gait pattern alterations which are mainly due to spasticity and treated with repetitive multifocal botulinum toxin injection(BTI). Several studies demonstrated that single BTI-session in a single muscle of paretic lower limb(LL) improved kinematic gait parameters(GP) but surprisingly… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Botulinum Toxins Injection in Stroke Patients
- What is being tested?
- Motion Analysis
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2017to Dec 2019
- Phase
- Observational
- 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
Study population: STROKE PATIENTS
Who may be able to join
- >18 years
- a single hemispheric cerebral vascular lesion more than 6 months previously
- able to walk 10 meters without any assistance
- having benefited of at least 2 consecutive BTI sessions, second 3D gait analysis performed at least 3 months after the last BTI.
Who cannot join
- patient's refusal to participate to the study
- Inability to read the selected text
- Inability to cooperate
- No affiliation to social security
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Raymond Poincaré hospital
Garches, 92210
Nicolas ROCHE, Md, PhD, 0033147105409, roche.nicolas@aphp.fr
About this study
Official title: Effect of 3 Consecutives Botulinum Toxin Injection on Gait Pattern in Stroke Patients
Chronic stroke patients exhibit gait pattern alterations which are mainly due to spasticity and treated with repetitive multifocal botulinum toxin injection(BTI). Several studies demonstrated that single BTI-session in a single muscle of paretic lower limb(LL) improved kinematic gait parameters(GP) but surprisingly none of them assessed the effects of repetitive multifocal BTI on patient's gait pattern and their duration.
The aim was to evaluate the impact of repetitive multifocal BTI-sessions on GP of chronic stroke patients. To that end, gait of patients will be compared using 3D-gait analysis after 3 consecutives BTI sessions.
Read the detailed description
All the patients will be treated with BTI . These injections will be performed under electrical stimulation control (~5mA). The dose, the number of site of injection per muscle is at the discretion of the physician according to patients' needs and physicians' routine clinical practice. The dilution the most commonly used will be 100 U for 2.5ml (XEOMIN®)
- Being tested
- Motion Analysis
- Keywords
- Botulinum toxin injections, Stroke, 3D motion analysis, Gait pattern
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motion AnalysisOther
Motion analysis is used to assess the modifications of gait pattern in chronic spastic stroke patients regularly treated with botulinum toxin injection
| Study group | Role | What they receive |
|---|---|---|
| Chronic spastic stroke patients | Chronic spastic stroke patients treated regularly with botulinum toxin injection in lower limb muscles Receives: Other: Motion Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
kinematics gait parameters
peak knee flexion in swing phase(°)
Measured: 3h
Secondary outcomes (1)
spatiotemporal gait parameters
Gait velocity (m/s)
Measured: 3h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study start12 Dec 2017
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Botulinum Toxins Injection in Stroke PatientsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Garches
- Responsible party
- Principal investigator, Nicolas ROCHE, Centre d'Investigation Clinique et Technologique 805
- Investigators
- Nicolas ROCHE, MD PhD, Principal investigator, Raymond Poincare Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699775
- Sponsor's protocol ID
- 2015-A01671-48
- Acronym
- TRITITOX
- Status last verified
- Jan 2018
- First submitted
- 1 Mar 2016
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 3 Consecutives Botulinum Toxin Injection on Gait Pattern in Stroke Patients
- ClinicalTrials.gov ID
- NCT02699775
- Acronym / sponsor ID
- TRITITOX / 2015-A01671-48
- Keywords
- Botulinum toxin injections, Stroke, 3D motion analysis, Gait pattern
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Collaborators
- Fondation Garches
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 4 Mar 2016 (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.
Chronic stroke patients exhibit gait pattern alterations which are mainly due to spasticity and treated with repetitive multifocal botulinum toxin injection(BTI). Several studies demonstrated that single BTI-session in a single muscle of paretic lower limb(LL) improved kinematic gait parameters(GP) but surprisingly none of them assessed the effects of repetitive multifocal BTI on patient's gait pattern and their duration.
The aim was to evaluate the impact of repetitive multifocal BTI-sessions on GP of chronic stroke patients. To that end, gait of patients will be compared using 3D-gait analysis after 3 consecutives BTI sessions.
Detailed description
All the patients will be treated with BTI . These injections will be performed under electrical stimulation control (~5mA). The dose, the number of site of injection per muscle is at the discretion of the physician according to patients' needs and physicians' routine clinical practice. The dilution the most commonly used will be 100 U for 2.5ml (XEOMIN®)
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic spastic stroke patients | – | Other: Motion AnalysisChronic spastic stroke patients treated regularly with botulinum toxin injection in lower limb muscles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- STROKE PATIENTS
Key inclusion criteria (4 listed)
- >18 years
- a single hemispheric cerebral vascular lesion more than 6 months previously
- able to walk 10 meters without any assistance
- having benefited of at least 2 consecutive BTI sessions, second 3D gait analysis performed at least 3 months after the last BTI.
Key exclusion criteria (4 listed)
- patient's refusal to participate to the study
- Inability to read the selected text
- Inability to cooperate
- No affiliation to social security
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 |
|---|---|---|
| Motion AnalysisMotion analysis is used to assess the modifications of gait pattern in chronic spastic stroke patients regularly treated with botulinum toxin injection | Other | Chronic spastic stroke patients |
Primary outcome
kinematics gait parameters
Time frame: 3h
peak knee flexion in swing phase(°)
1 secondary outcome
spatiotemporal gait parameters
Time frame: 3h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: No
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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
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Extracorporeal Shock Wave Therapy in Botulinum Toxin-Treated Patients With Post-Stroke Ankle Plantar Flexor Spasticity
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Pilot Study on Muscle, Tendon, and Neural Changes Post-Botulinum Toxin Injections in Post-stroke Spastic Equinovarus
Stroke, Spasticity
Active, not recruitingObservational study
Evaluation of Spasticity, Neuropathic Pain, and Gait Analysis in Stroke Patients Receiving Tolperison Therapy After Botulinum Toxin Injection
Spastic Hemiplegia
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.
Nicolas ROCHE, MD PhD principal investigator
Raymond Poincare Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Botulinum Toxins Injection in Stroke Patients, run by Centre d'Investigation Clinique et Technologique 805 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 4 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: status not confirmed, as of the sponsor's last update on 25 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas ROCHE, MD PhD (0033147105409, roche.nicolas@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
kinematics gait parameters (time frame: 3h). 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 25 Jan 2018.