CHU de Nantes
Nantes, France
NCT Number: NCT04717141
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Nantes, France
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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D0 :
D28 (+/-5 days) :
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.
Time frame: 20 minutes post selective nerve block at Day 0
Study of the variation of the proximal soleus muscle stiffness between before and after performing the selective nerve block of the soleus nerve
Time frame: 20 minutes post selective nerve block at Day 0
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)
Time frame: 20 minutes post selective nerve block at Day 0
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.
Time frame: Day 28 post botulinum toxin injection
Variation of the muscle stiffness of the distal and proximal soleus between before and after botulinum toxin injection.
Time frame: Day 28 post 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.
Time frame: Day 28 post botulinum toxin injection
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.
Nantes University Hospital
Other
Acronym: RAI PAR BLOC
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