StrokeNCT01935544
Effectiveness of Two Techniques in Injection Site Spotting for Botulinum Toxin Injections: Echography or Electro Stimulation.
A study testing Botulinum toxin injection in people with Stroke, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Botulinum toxin injections are an effective treatment of limb spasticity after stroke. Different tracking techniques are used to locate a proper injection spot. Palpatory technique is barely effective and induces a high risk of error. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Botulinum toxin injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 19 Nov 2013to 12 Feb 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years.
- Hemiplegia sequelae of stroke
- Spasticity of the triceps surae listed at least 1 + / 4 on the modified Ashworth scale
- Ability to give written consent
Who cannot join
- Injection of botulinum toxin older than 3 months
- Patient who has already received ultrasound-guided injection of botulinum toxin
- Indication of botulinum toxin injection in other muscle groups in the lower limb than triceps surae
- Swallowing impairment
- Ongoing AVK anticoagulation treatment with INR greater than 3 during one week before randomization.
- Ongoing treatment by aminoglycosides
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- General anesthesia with injection of curare planned during the participation in the protocol
- Wearing a pacemaker
- History of ankle arthrodesis
- Other cons-indication for botulinum toxin injection: myasthenia gravis, pregnancy, lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Botulinum toxin injections are an effective treatment of limb spasticity after stroke. Different tracking techniques are used to locate a proper injection spot. Palpatory technique is barely effective and induces a high risk of error. Localization by electro stimulation is frequently used in adults, but often requires multiple painful repositioning of the needle. Ultrasound tracking is sometimes used in children but not much in adults.
The advantages of ultrasound-guided botulinum toxin injections are a painless localization and greater injection accuracy. Safety is therefore enhanced since intravascular injection is easily avoided.
The few existing publications on the subject are essentially case reports. Few studies have focused on comparing different injection techniques and so far, no well-conducted study has highlighted superior efficiency of ultrasound-guided injections.
Read the detailed description
Objectives:
The main objective is to compare the efficiency of botulinum toxin injections depending on the localization technique: ultrasound vs. electrical stimulation.
The secondary objective is to demonstrate less painful localization associated to ultrasound-guidance.
Evaluations:
The primary endpoint is the variation of passive range of motion of ankle dorsiflexion at slow speed and high speed ("Tardieu scale") while keeping knee straight.
The secondary endpoints are:
- The other components of the "Tardieu scale": quality of muscle reaction (X) at slow speed and fast speed, angle of apparition of the muscle reaction (Y) at slow speed and fast speed.
- Assessment of spasticity of the triceps surae on the modified Ashworth scale.
- The walking speed.
- The extent of pain at the injection site by visual analogue scale.
- The duration of tracking and injection.
Methodology:
This prospective, randomized, single-center, single-blind, cross-over, study will be conducted in chronic stroke patients with spasticity of the triceps surae.
Patients will receive two injections during the protocol, each with a different technique of localization. Randomization will determine which technique will be used in the first and the second place.
Patients will be selected from the cohort of patients supported by consultation of Physical Medicine and Rehabilitation Department of the University Hospital of Clermont-Ferrand. Injections of botulinum toxin and assessments will take place in the same department.
The study period is five months for each patient. This study does not present a major risk for the subjects. The main inconvenience is injection pain or side effects of botulinum toxin (increase of motor deficits or dysphagia).
- Conditions
- Stroke
- Being tested
- Botulinum toxin injection
- Keywords
- Botulinum Toxin, Ultrasound-guidance, Stroke, Spasticity, Ultrasonography, Hemiplegia
- Medical subject headings
- Stroke, Muscle Spasticity, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin injectionDevice
| Study group | Role | What they receive |
|---|---|---|
| botulinum toxin injections | Experimental | The main objective is to compare the efficiency of botulinum toxin injections depending on the localization technique: ultrasound vs. electrical stimulation. Receives: Device: Botulinum toxin injection |
| ultrasound guidance | Other | The secondary objective is to demonstrate less painful localization associated to ultrasound-guidance Receives: Device: Botulinum toxin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Measured: at inclusion
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Measured: at day 1 (first injection)
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Measured: at day 60
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Measured: at day 120 (second injection)
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Measured: at day 150
Secondary outcomes (6)
Tardieu scale: quality of muscle reaction at slow speed and fast speed
Measured: at Inclusion, D1, D60, D120 and D150
Angle of apparition of the muscle reaction at slow speed and fast speed
Measured: at Inclusion, D1, D60, D120 and D150
Spasticity of the triceps surae on the modified Ashworth scale
Measured: at Inclusion, D1, D60, D120 and D150
Walking speed
Measured: at Inclusion, D1, D60, D120 and D150
Extent of pain at the injection site by visual analogue scale
Measured: at D1, D120
Duration of tracking and injection
Measured: at D1, D120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study start19 Nov 2013
- Primary completion12 Feb 2019
- Study completion12 Feb 2019
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 StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle HAURET, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935544
- Sponsor's protocol ID
- CHU-0153
- Status last verified
- Jul 2026
- First submitted
- 6 May 2013
- Last updated
- 3 Aug 2026
- Results posted
- No
Publications
Morel C, Hauret I, Andant N, Bonnin A, Pereira B, Coudeyre E. Efficacy of two injection-site localisation techniques for botulinum toxin injections: a single-blind, crossover, randomised trial protocol among adults with hemiplegia due to stroke. BMJ Open. 2016 Nov 15;6(11):e011751. doi: 10.1136/bmjopen-2016-011751.
PubMed 27852706
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Two Techniques in Injection Site Spotting for Botulinum Toxin Injections: Echography or Electro Stimulation.
- ClinicalTrials.gov ID
- NCT01935544
- Acronym / sponsor ID
- CHU-0153
- Conditions
- Stroke
- Keywords
- Botulinum Toxin, Ultrasound-guidance, Stroke, Spasticity, Ultrasonography, Hemiplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 19 Nov 2013 (actual)
- Primary completion
- 12 Feb 2019 (actual)
- Study completion
- 12 Feb 2019 (actual)
- First posted
- 5 Sep 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.
Botulinum toxin injections are an effective treatment of limb spasticity after stroke. Different tracking techniques are used to locate a proper injection spot. Palpatory technique is barely effective and induces a high risk of error. Localization by electro stimulation is frequently used in adults, but often requires multiple painful repositioning of the needle. Ultrasound tracking is sometimes used in children but not much in adults.
The advantages of ultrasound-guided botulinum toxin injections are a painless localization and greater injection accuracy. Safety is therefore enhanced since intravascular injection is easily avoided.
The few existing publications on the subject are essentially case reports. Few studies have focused on comparing different injection techniques and so far, no well-conducted study has highlighted superior efficiency of ultrasound-guided injections.
Detailed description
Objectives:
The main objective is to compare the efficiency of botulinum toxin injections depending on the localization technique: ultrasound vs. electrical stimulation.
The secondary objective is to demonstrate less painful localization associated to ultrasound-guidance.
Evaluations:
The primary endpoint is the variation of passive range of motion of ankle dorsiflexion at slow speed and high speed ("Tardieu scale") while keeping knee straight.
The secondary endpoints are:
- The other components of the "Tardieu scale": quality of muscle reaction (X) at slow speed and fast speed, angle of apparition of the muscle reaction (Y) at slow speed and fast speed.
- Assessment of spasticity of the triceps surae on the modified Ashworth scale.
- The walking speed.
- The extent of pain at the injection site by visual analogue scale.
- The duration of tracking and injection.
Methodology:
This prospective, randomized, single-center, single-blind, cross-over, study will be conducted in chronic stroke patients with spasticity of the triceps surae.
Patients will receive two injections during the protocol, each with a different technique of localization. Randomization will determine which technique will be used in the first and the second place.
Patients will be selected from the cohort of patients supported by consultation of Physical Medicine and Rehabilitation Department of the University Hospital of Clermont-Ferrand. Injections of botulinum toxin and assessments will take place in the same department.
The study period is five months for each patient. This study does not present a major risk for the subjects. The main inconvenience is injection pain or side effects of botulinum toxin (increase of motor deficits or dysphagia).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| botulinum toxin injections | Experimental | Device: Botulinum toxin injectionThe main objective is to compare the efficiency of botulinum toxin injections depending on the localization technique: ultrasound vs. electrical stimulation. |
| ultrasound guidance | Other | Device: Botulinum toxin injectionThe secondary objective is to demonstrate less painful localization associated to ultrasound-guidance |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 80 years.
- Hemiplegia sequelae of stroke
- Spasticity of the triceps surae listed at least 1 + / 4 on the modified Ashworth scale
- Ability to give written consent
Key exclusion criteria (10 listed)
- Injection of botulinum toxin older than 3 months
- Patient who has already received ultrasound-guided injection of botulinum toxin
- Indication of botulinum toxin injection in other muscle groups in the lower limb than triceps surae
- Swallowing impairment
- Ongoing AVK anticoagulation treatment with INR greater than 3 during one week before randomization.
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 |
|---|---|---|
| Botulinum toxin injection | Device | botulinum toxin injections, ultrasound guidance |
Primary outcome
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Time frame: at inclusion
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Time frame: at day 1 (first injection)
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Time frame: at day 60
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Time frame: at day 120 (second injection)
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Time frame: at day 150
6 secondary outcomes
Tardieu scale: quality of muscle reaction at slow speed and fast speed
Time frame: at Inclusion, D1, D60, D120 and D150
Angle of apparition of the muscle reaction at slow speed and fast speed
Time frame: at Inclusion, D1, D60, D120 and D150
Spasticity of the triceps surae on the modified Ashworth scale
Time frame: at Inclusion, D1, D60, D120 and D150
Walking speed
Time frame: at Inclusion, D1, D60, D120 and D150
Extent of pain at the injection site by visual analogue scale
Time frame: at D1, D120
Duration of tracking and injection
Time frame: at D1, D120
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 3 Aug 2026.
- Derived from this study: PubMed 27852706Morel C, Hauret I, Andant N, Bonnin A, Pereira B, Coudeyre E. Efficacy of two injection-site localisation techniques for botulinum toxin injections: a single-blind, crossover, randomised trial protocol among adults with hemiplegia due to stroke. BMJ Open. 2016 Nov 15;6(11):e011751. doi: 10.1136/bmjopen-2016-011751.
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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.
Isabelle HAURET principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum toxin injection in people with Stroke, run by University Hospital, Clermont-Ferrand 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 10 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 3 Aug 2026. 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?
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight (time frame: at inclusion). The study lists 5 primary outcomes in all. 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 NCT01935544, 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 3 Aug 2026.