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

NCT04717141 | Completed

• 1 other identifier: RC19_0373
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Accident

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  20 minutes post selective nerve block at Day 0

• Neurophysiological effects of the motor block on nerve transmission and muscle activation.

  20 minutes post selective nerve block at Day 0

• Inter-individual variability of the decrease in muscle stiffness after selective nerve block

  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.

  Day 28 post botulinum toxin injection

• Inter-individual variability of the decrease in muscle stiffness after botulinum toxin injection.

  Day 28 post botulinum toxin injection

Study Arms (1)

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.

Other: Selective nerve block

Interventions

Selective nerve block 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.

Biomecanical evaluation of the selective nerve block effects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),
• Be eligible for social security.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 20, 2021
• Study Start: February 3, 2021
• Primary Completion: July 10, 2023
• Study Completion: July 10, 2023
• Last Updated: July 24, 2023

Record last verified: 2023-07

Locations

FR (1)