Effect of Repeated Botulinum Toxin Injection on Gait Pattern in Stroke PatientsNCT01973023
Stroke's Gait Pattern Modifications of Induced by Repeated BTI
An observational study of Effect of Repeated Botulinum Toxin Injection on Gait Pattern 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
- Effect of Repeated Botulinum Toxin Injection on Gait Pattern in Stroke Patients
- What is being tested?
- Motion analysis
- Type of treatment
- Injection or infusion
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to Jan 2014
- 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.
About this study
Official title: Improvement of Chronic Stroke Patients Gait Pattern Following Repetitive Multifocal Botulinum Toxin Injection Sessions in Paretic Lower Limb: an Observational Study.
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 has been compared using 3D-gait analysis after at least 2 consecutive BTI sessions.
Read the detailed description
All the patients will be tretaed 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 depend on the type of BoNT-A (BOTOX®, XEOMIN® or DYSPORT®) and was 100 U for 2.5ml (BOTOX® and XEOMIN®) or 500 U for 2.5 ml (Dysport®).
- Being tested
- Motion analysis
- Keywords
- botulinum toxin injection, 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 was 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 parmeters
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 posted31 Oct 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Repeated Botulinum Toxin Injection on Gait Pattern 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
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas ROCHE, Centre d'Investigation Clinique et Technologique 805
- Investigators
- ROCHE Nicolas, MDPHD, Principal investigator, HOPITAL RAYMOND POINCARE-GARCHES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973023
- Sponsor's protocol ID
- 1687472
- Status last verified
- Mar 2014
- First submitted
- 9 Oct 2013
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Chronic Stroke Patients Gait Pattern Following Repetitive Multifocal Botulinum Toxin Injection Sessions in Paretic Lower Limb: an Observational Study.
- ClinicalTrials.gov ID
- NCT01973023
- Acronym / sponsor ID
- 1687472
- Keywords
- botulinum toxin injection, stroke, 3D motion analysis, gait pattern
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- Jul 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 31 Oct 2013 (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 has been compared using 3D-gait analysis after at least 2 consecutive BTI sessions.
Detailed description
All the patients will be tretaed 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 depend on the type of BoNT-A (BOTOX®, XEOMIN® or DYSPORT®) and was 100 U for 2.5ml (BOTOX® and XEOMIN®) or 500 U for 2.5 ml (Dysport®).
Study design
- Time perspective
- Retrospective
- 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 was 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 parmeters
Time frame: 3h
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 2 Mar 2016.
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.
ROCHE Nicolas, MDPHD principal investigator
HOPITAL RAYMOND POINCARE-GARCHES
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 Effect of Repeated Botulinum Toxin Injection on Gait Pattern 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: finished, as of the sponsor's last update on 2 Mar 2016. 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?
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?
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 2 Mar 2016.