Cerebrovascular AccidentRAI PAR BLOCNCT04717141
Biomechanical and Neurophysiological Evaluation of the Effect of a Motor Block and an Injection of Botulinum Toxin on the Stiffness of the Paretic Sural Triceps Muscle
A study testing Selective nerve block in people with Cerebrovascular Accident, run by Nantes University Hospital at 1 site in France.
Trial summary
The research "Biomechanical and neurophysiological evaluation of the effects of a motor block and an injection of botulinum toxin on the stiffness of the paretic sural triceps muscle" will study the response to passive stretching in the neurological patient presenting spastic paresis after a stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Selective nerve block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2021to 10 Jul 2023
- 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
- Patient with signed consent,
- Be over 18 and under 80 years of age,
- Have suffered a stroke (medical diagnosis),
- Spasticity of the triceps surae with a modified Ashworth score of the triceps sural of at least 1,
- Medical indication to perform a treatment of spasticity of the sural triceps by ITB, requiring a prior selective nerve block to qualify or disqualify this procedure (depending on the effectiveness, reaction / sensations / perceptions of the patient),
- Cognitive abilities compatible with experimentation: absence of language or judgment impairments that prevent the understanding of the research or the expression of agreement. An aphasia severity score > or equal to 3 will be required for inclusion,
- Be eligible for social security.
Who cannot join
- Person in an emergency situation, deprived of liberty, or not benefiting from the social protection system,
- Person under 18 years of age or under any legal protection measure whatsoever,
- Unbalanced epileptic disorder; tension variability,
- History of calf surgery (scarring areas that disrupt ultrasound elastography exploration),
- Disorders related to bed rest: thromboembolic disorders, bedsores, respiratory or digestive disorders,
- Previous botulinum toxin injection injection less than 3 months ago (contraindication to a new botulinum toxin injection),
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- Contraindication to an injection of botulinum toxin abobotulinum toxin A (Dysport®),
- Patient under anti-coagulant,
- Aphasia or cognitive impairment interfering with task comprehension,
- Contraindication to ankle manipulation: fracture, phlebitis, pressure sore in the areas of support of the orthosis,
- Pregnant or breastfeeding women.
- Translated with www.DeepL.com/Translator (free version)
Trial locations and contacts
1 site in 1 country.
About this study
The research "Biomechanical and neurophysiological evaluation of the effects of a motor block and an injection of botulinum toxin on the stiffness of the paretic sural triceps muscle" will study the response to passive stretching in the neurological patient presenting spastic paresis after a stroke.
Read the detailed description
Following a stroke, patients see their motor function impaired, in particular by the establishment of muscular retractions. These affect motor performance of the patients, as for example by impairing their walking capabilities and are responsible for long-term orthopedic deformities. Muscular structure influencing ankle and foot mobility are particularly evaluated in daily practice due to the major impact of muscle retraction on patients' mobility.
During clinical examination, the evaluator searches the presence of the clinical markers of muscle retraction. However their clinical evaluation remains subjective and does not always allow to identify the precise location (which muscles) and origin (muscle contraction or retraction) of the observed response.
In that case, the sensitive nerve block (BNS)can complete the clinical examination. Its efficacy and selectivity are difficult to evaluate in a precise manner by a clinical examination on its own. Moreover, the possibility to predict the effect of a long-lasting spasticity treatment, like a botulinum toxin injection (ITB), from the effect of a BNS, has not been proven on the sural triceps muscle.
The study will use several evaluation techniques by biomechanical, neurophysiological and ultrasound (elastography) study which allow to quantify the response level within a muscle (measure of the muscle stiffness and retraction).
This study will take place within the rehabilitation and physical medicine department, patients are hospitalized or seen during stroke follow-up examination for uncomfortable sural triceps spasticity. They are evaluated by a quantified walking test, followed by a BNS, if the BNS result is positive, they are treated by a botulinum toxin injection in the sural triceps. The stiffness measurements before BNS (J0), after BNS (J0 post BNS) and after ITB (at day 28) will be standardized and additional instrumental examinations will be realized to understand the effects of the BNS and ITB procedure. The stretching will be performed by an isokinetic dynamometer and the muscle response to the stretching will be achieved by simultaneous evaluation of the response of the leg muscles by elastography and electromyography. In addition, clinical and neurophysiological data (exploration of nerve conduction on the tibial nerve) will be measured
- Conditions
- Cerebrovascular Accident
- Being tested
- Selective nerve block
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective nerve blockOther
D0 :
- Information, collection of consent, inclusion,
- Clinical and instrumental evaluation,
- Realization of the selective nerve block,
- Post-selective nerve block clinical and instrumental re-evaluation,
- Performance of the botulinum toxin injection if indication selected.
D28 (+/-5 days) :
- Clinical and instrumental post-botulinum toxin injection evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Biomecanical evaluation of the selective nerve block effects | Experimental | D0 :
* Information, collection of consent, inclusion,
* Clinical and instrumental evaluation,
* Realization of the selective nerve block,
* Post-selective nerve block clinical and instrumental re-evaluation,
* Performance of the botulinum toxin injection if indication selected.
D28 (+/-5 days) :
- Clinical and instrumental post-botulinum toxin injection evaluation. Receives: Other: Selective nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomecanical evaluation of the selective nerve block effects on soleus muscle stiffness (distal part) during stretching of the plantar flexor muscles in the patient after a stroke.
Study of the soleus (distal) muscle stiffness before and after the realization of selective nerve block of the soleus nerve. The muscle stiffness is assessed by measuring the shearing module (in kilopascals) by elastography SSI during the slow passive stretching (2°/sec) realized by an isokinetic ergometer during the examination before and after the selective nerve block realization.
Measured: 20 minutes post selective nerve block at Day 0
Secondary outcomes (6)
Biomechanical effect of selective nerve block on proximal soleus muscle stiffness when stretching plantar flexor muscles
Study of the variation of the proximal soleus muscle stiffness between before and after performing the selective nerve block of the soleus nerve
Measured: 20 minutes post selective nerve block at Day 0
Neurophysiological effects of the motor block on nerve transmission and muscle activation.
Neurophysiological effects will be evaluated by: (i) the variations in amplitude and latency of the M wave, of the H response, and of the Hmax/Mmax ratio, and (ii) the change in muscle activity (measured by electromyography) between before and after selective nerve block. Muscle activity will be recorded during the entire passive dorsal ankle flexion movement with the dynamometer. It will be quantified by the area under the curve of the EMG signal recorded for each site (distal soleus and proximal soleus), after usual treatment of the EMG signal to obtain an envelope (filtering, rectification and normalization)
Measured: 20 minutes post selective nerve block at Day 0
Inter-individual variability of the decrease in muscle stiffness after selective nerve block
Variability of the selective nerve block response between the patients, measures of the decrease in muscle stiffness will be taken into account for each musce site : distal soleus and proximal soleus.
Measured: 20 minutes post selective nerve block at Day 0
Biomechanical effect of botulinum toxin injection on muscle stiffness of the soleus (distal part) when stretching the plantar flexor muscles.
Variation of the muscle stiffness of the distal and proximal soleus between before and after botulinum toxin injection.
Measured: Day 28 post botulinum toxin injection
Inter-individual variability of the decrease in muscle stiffness after botulinum toxin injection.
Inter-patient variability for the answer to the botulinum toxin injection, muscle stiffness reduction measures will be taken into account for each muscle site : distal soleus and proximal soleus.
Measured: Day 28 post botulinum toxin injection
Relationship between selective nerve block effect and botulinum toxin injection effect.
The relationship between the selective nerve block effect and the botulinum toxin injection effect will be evaluated by calculating correlations between the stiffness variation before and after each intervention.
Measured: Day 28 post botulinum toxin injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start3 Feb 2021
- Primary completion10 Jul 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717141
- Sponsor's protocol ID
- RC19_0373
- Acronym
- RAI PAR BLOC
- Status last verified
- Jul 2023
- First submitted
- 15 Jan 2021
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical and Neurophysiological Evaluation of the Effect of a Motor Block and an Injection of Botulinum Toxin on the Stiffness of the Paretic Sural Triceps Muscle
- ClinicalTrials.gov ID
- NCT04717141
- Acronym / sponsor ID
- RAI PAR BLOC / RC19_0373
- Conditions
- Cerebrovascular Accident
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 20 Jan 2021 (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.
The research "Biomechanical and neurophysiological evaluation of the effects of a motor block and an injection of botulinum toxin on the stiffness of the paretic sural triceps muscle" will study the response to passive stretching in the neurological patient presenting spastic paresis after a stroke.
Detailed description
Following a stroke, patients see their motor function impaired, in particular by the establishment of muscular retractions. These affect motor performance of the patients, as for example by impairing their walking capabilities and are responsible for long-term orthopedic deformities. Muscular structure influencing ankle and foot mobility are particularly evaluated in daily practice due to the major impact of muscle retraction on patients' mobility.
During clinical examination, the evaluator searches the presence of the clinical markers of muscle retraction. However their clinical evaluation remains subjective and does not always allow to identify the precise location (which muscles) and origin (muscle contraction or retraction) of the observed response.
In that case, the sensitive nerve block (BNS)can complete the clinical examination. Its efficacy and selectivity are difficult to evaluate in a precise manner by a clinical examination on its own. Moreover, the possibility to predict the effect of a long-lasting spasticity treatment, like a botulinum toxin injection (ITB), from the effect of a BNS, has not been proven on the sural triceps muscle.
The study will use several evaluation techniques by biomechanical, neurophysiological and ultrasound (elastography) study which allow to quantify the response level within a muscle (measure of the muscle stiffness and retraction).
This study will take place within the rehabilitation and physical medicine department, patients are hospitalized or seen during stroke follow-up examination for uncomfortable sural triceps spasticity. They are evaluated by a quantified walking test, followed by a BNS, if the BNS result is positive, they are treated by a botulinum toxin injection in the sural triceps. The stiffness measurements before BNS (J0), after BNS (J0 post BNS) and after ITB (at day 28) will be standardized and additional instrumental examinations will be realized to understand the effects of the BNS and ITB procedure. The stretching will be performed by an isokinetic dynamometer and the muscle response to the stretching will be achieved by simultaneous evaluation of the response of the leg muscles by elastography and electromyography. In addition, clinical and neurophysiological data (exploration of nerve conduction on the tibial nerve) will be measured
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biomecanical evaluation of the selective nerve block effects | Experimental | Other: Selective nerve blockD0 : * Information, collection of consent, inclusion, * Clinical and instrumental evaluation, * Realization of the selective nerve block, * Post-selective nerve block clinical and instrumental re-evaluation, * Performance of the botulinum toxin injection if indication selected. D28 (+/-5 days) : - Clinical and instrumental post-botulinum toxin injection evaluation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient with signed consent,
- Be over 18 and under 80 years of age,
- Have suffered a stroke (medical diagnosis),
- Spasticity of the triceps surae with a modified Ashworth score of the triceps sural of at least 1,
- Medical indication to perform a treatment of spasticity of the sural triceps by ITB, requiring a prior selective nerve block to qualify or disqualify this procedure (depending on the effectiveness, reaction / sensations / perceptions of the patient),
Key exclusion criteria (12 listed)
- Person in an emergency situation, deprived of liberty, or not benefiting from the social protection system,
- Person under 18 years of age or under any legal protection measure whatsoever,
- Unbalanced epileptic disorder; tension variability,
- History of calf surgery (scarring areas that disrupt ultrasound elastography exploration),
- Disorders related to bed rest: thromboembolic disorders, bedsores, respiratory or digestive disorders,
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 |
|---|---|---|
| Selective nerve blockD0 : * Information, collection of consent, inclusion, * Clinical and instrumental evaluation, * Realization of the selective nerve block, * Post-selective nerve block clinical and instrumental re-evaluation, * Performance of the botulinum toxin injection if indication selected. D28 (+/-5 days) : - Clinical and instrumental post-botulinum toxin injection evaluation. | Other | Biomecanical evaluation of the selective nerve block effects |
Primary outcome
Biomecanical evaluation of the selective nerve block effects on soleus muscle stiffness (distal part) during stretching of the plantar flexor muscles in the patient after a stroke.
Time frame: 20 minutes post selective nerve block at Day 0
Study of the soleus (distal) muscle stiffness before and after the realization of selective nerve block of the soleus nerve. The muscle stiffness is assessed by measuring the shearing module (in kilopascals) by elastography SSI during the slow passive stretching (2°/sec) realized by an isokinetic ergometer during the examination before and after the selective nerve block realization.
6 secondary outcomes
Biomechanical effect of selective nerve block on proximal soleus muscle stiffness when stretching plantar flexor muscles
Time frame: 20 minutes post selective nerve block at Day 0
Neurophysiological effects of the motor block on nerve transmission and muscle activation.
Time frame: 20 minutes post selective nerve block at Day 0
Inter-individual variability of the decrease in muscle stiffness after selective nerve block
Time frame: 20 minutes post selective nerve block at Day 0
Biomechanical effect of botulinum toxin injection on muscle stiffness of the soleus (distal part) when stretching the plantar flexor muscles.
Time frame: Day 28 post botulinum toxin injection
Inter-individual variability of the decrease in muscle stiffness after botulinum toxin injection.
Time frame: Day 28 post botulinum toxin injection
Relationship between selective nerve block effect and botulinum toxin injection effect.
Time frame: Day 28 post botulinum toxin 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 24 Jul 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective nerve block in people with Cerebrovascular Accident, run by Nantes University Hospital 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 7 inclusion and 12 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 24 Jul 2023. 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?
Biomecanical evaluation of the selective nerve block effects on soleus muscle stiffness (distal part) during stretching of the plantar flexor muscles in the patient after a stroke. (time frame: 20 minutes post selective nerve block at Day 0). 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 24 Jul 2023.