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

NCT ID: NCT04717141

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-03
• Study Completion Date: 2023-07-10

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Biomecanical evaluation of the selective nerve block effects

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.

Group Type: EXPERIMENTAL

Selective nerve block

Intervention Type: OTHER

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.

Interventions

Selective nerve block

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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),
• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Nantes

Nantes, , France

Countries

France

Other Identifiers

RC19_0373

Identifier Type: -

Identifier Source: org_study_id