Proximal Lower Limb Intramuscular Block : Effects on Hemiparetic Gait

N/AUnknownNCT05519592

Henri Mondor University Hospital30 enrolled

Overview

To assess feasability, tolerance of anesthesic intramuscular motor block. To study immediate effects on differents muscles : gluteus maximus, rectus femoris in a hemiparetic population (over 15 days) To precise the role of the muscles which could be rehabilitatoin targets.

Spastic paresis comprises both muscular and neurological disorders affecting movement through mostly the antagonist muscles compared to the agonist : muscular : spastic myopathy, shortening, stretch-sensitive paresis and neurogenic : spastic dystonia and cocontraction. About gait, most of the litterature focuses on distal muscles targets. There are no studies about proxmial muscles role (gluteus maximus). Anesthesic perineural block have the disavantage to induce sensitive block as intramuscular block do not.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE

Enrollment

Conditions

Neurologic Disorder Spastic Hemiplegia Gait, Hemiplegic Block

Interventions

Ropivacaine injectionDRUG

Intramuscular ropivacaine injection (gluteus maximus and rectus femoris)

Sodium Chloride InjectionDRUG

Intramuscular sodium chloride injection (gluteus maximus and rectus femoris)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * able to consent * avoiding ground swing phase gait disorder Exclusion Criteria: * severe cognitive disorder * INR \> 3.5 * local cutaneous affection on injection sites * acute medical affection * seizure * hypersensitivity to anesthesics * brugada syndrome * porphyria * severe cardiac disorder * polyradiculopathy * botulinum toxin injection \< 2 months

Outcomes

Primary Outcomes

Change from baseline of the active amplitude of hip flexion, knee flexion and ankle flexion

Time frame: baseline, day 7 and day 14

Secondary Outcomes

change from baseline of the walking speed, at maximal speed, with shoes

Time frame: baseline, day 7 and day 14

change from baseline of the walking speed, at maximal speed, without shoes

Time frame: baseline, day 7 and day 14

change from baseline of the walking speed, at comfortable speed with shoes

Time frame: baseline, day 7 and day 14

change from baseline of the walking speed, at comfortable speed without shoes

Time frame: baseline, day 7 and day 14

change from baseline of the right step length, at maximal speed, with shoes

Time frame: baseline, day 7 and day 14

change from baseline of the left step length, at maximal speed, with shoes

Time frame: baseline, day 7 and day 14

change from baseline of the left step length, at maximal speed, without shoes

Time frame: baseline, day 7 and day 14

change from baseline of the right step length, at maximal speed, without shoes

Time frame: baseline, day 7 and day 14

change from baseline of the right step length, at comfortable speed, without shoes

Time frame: baseline, day 7 and day 14

Central Contacts

etienne savard

CONTACT

0033149813299 etienne.savard@aphp.fr

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

change from baseline of the right step length, at comfortable speed, with shoes

Time frame: baseline, day 7 and day 14

change from baseline of the left step length, at comfortable speed, with shoes

Time frame: baseline, day 7 and day 14

change from baseline of the left step length, at comfortable speed, without shoes

Time frame: baseline, day 7 and day 14

change from baseline of the cadence (step per second), at comfortable speed, without shoes

Time frame: baseline, day 7 and day 14

change from baseline of the cadence (step per second), at comfortable speed, with shoes

Time frame: baseline, day 7 and day 14

change from baseline of the cadence (step per second), at maximal speed, with shoes

Time frame: baseline, day 7 and day 14

change from baseline of the cadence (step per second), at maximal speed, without shoes

Time frame: baseline, day 7 and day 14

change from baseline of Proprioception detection of gluteus maximus (minimal detectable change in degrees)

using the five steps assessment (Gracies JM)

Time frame: baseline, day 7 and day 14

change from baseline of Proprioception detection of hamstrings (minimal detectable change in degrees)

using the five steps assessment (Gracies JM)

Time frame: baseline, day 7 and day 14

change from baseline of Proprioception detection of vastus (minimal detectable change in degrees)

using the five steps assessment (Gracies JM)

Time frame: baseline, day 7 and day 14

change from baseline of Proprioception detection of rectus femoris (minimal detectable change in degrees)

using the five steps assessment (Gracies JM)

Time frame: baseline, day 7 and day 14

change from baseline of Proprioception detection of soleus (minimal detectable change in degrees)

using the five steps assessment (Gracies JM)

Time frame: baseline, day 7 and day 14

change from baseline of Proprioception detection of gastrocnemius (minimal detectable change in degrees)

using the five steps assessment (Gracies JM)

Time frame: baseline, day 7 and day 14

change from baseline of Passive range of motion of gluteus maximus (muscle length in degrees)

using the five steps assessment (Gracies JM)

Time frame: baseline, day 7 and day 14

change from baseline of Passive range of motion of rectus femoris (muscle length in degrees)

using the five steps assessment (Gracies JM)

Time frame: baseline, day 7 and day 14

change from baseline of Passive range of motion of vastus (muscle length in degrees)

using the five steps assessment (Gracies JM)

Time frame: baseline, day 7 and day 14

change from baseline of Passive range of motion of soleus (muscle length in degrees)

using the five steps assessment (Gracies JM)

Time frame: baseline, day 7 and day 14

change from baseline of Passive range of motion of gastrocnemius (muscle length in degrees)

using the five steps assessment (Gracies JM)

Time frame: baseline, day 7 and day 14

change from baseline of Passive range of motion of hamstrings (muscle length in degrees)

using the five steps assessment (Gracies JM)

Time frame: baseline, day 7 and day 14

change from baseline of spasticity (angle in degrees) of hamstrings

using the five steps assessment (Gracies JM)

Time frame: baseline, day 7 and day 14

change from baseline of spasticity (angle in degrees) of gluteus maximus

using the five steps assessment (Gracies JM)

Time frame: baseline, day 7 and day 14

change from baseline of spasticity (angle in degrees) of rectus femoris

using the five steps assessment (Gracies JM)

Time frame: baseline, day 7 and day 14

change from baseline of spasticity (angle in degrees) of vastus

using the five steps assessment (Gracies JM)

Time frame: baseline, day 7 and day 14

change from baseline of spasticity (angle in degrees) of soleus

using the five steps assessment (Gracies JM)

Time frame: baseline, day 7 and day 14

change from baseline of spasticity (angle in degrees) of gastrocnemius

using the five steps assessment (Gracies JM)

Time frame: baseline, day 7 and day 14

change from baseline of active amplitude against gastrocnemius

Time frame: baseline, day 7 and day 14

change from baseline of active amplitude against soleus

Time frame: baseline, day 7 and day 14

change from baseline of active amplitude against hamstrings

Time frame: baseline, day 7 and day 14

change from baseline of active amplitude against gluteus maximus

Time frame: baseline, day 7 and day 14

change from baseline of active amplitude against rectus femoris

Time frame: baseline, day 7 and day 14

change from baseline of active amplitude against vastus

Time frame: baseline, day 7 and day 14

change from baseline of fatigability against vastus (in degrees, after 15 second of alternative movement)

using the five steps assessment (Gracies JM)

Time frame: baseline, day 7 and day 14

change from baseline of fatigability against rectus femoris (in degrees, after 15 second of alternative movement)

using the five steps assessment (Gracies JM)

Time frame: baseline, day 7 and day 14

change from baseline of fatigability against gluteus maximus (in degrees, after 15 second of alternative movement)

using the five steps assessment (Gracies JM)

Time frame: baseline, day 7 and day 14

change from baseline of fatigability against hamstrings (in degrees, after 15 second of alternative movement)

using the five steps assessment (Gracies JM)

Time frame: baseline, day 7 and day 14

change from baseline of fatigability against gastrocnemius (in degrees, after 15 second of alternative movement)

using the five steps assessment (Gracies JM)

Time frame: baseline, day 7 and day 14

change from baseline of fatigability against soleus (in degrees, after 15 second of alternative movement)

using the five steps assessment (Gracies JM)

Time frame: baseline, day 7 and day 14

change from baseline of patient global impression of improvement

GPI-I questionnaire

Time frame: baseline, day 7 and day 14

change from baseline of right foot pressure distribution

Time frame: baseline, day 7 and day 14

change from baseline of left foot pressure distribution

Time frame: baseline, day 7 and day 14

change from baseline of left foot load

Time frame: baseline, day 7 and day 14

change from baseline of right foot load

Time frame: baseline, day 7 and day 14

change from baseline of stride velocity variability

Time frame: baseline, day 7 and day 14

change from baseline of stride length variability

Time frame: baseline, day 7 and day 14

change from baseline of stride time variability

Time frame: baseline, day 7 and day 14

change from baseline of stance time variability

Time frame: baseline, day 7 and day 14

change from baseline of double support time variability

Time frame: baseline, day 7 and day 14

change from baseline of swing time assymetry

Time frame: baseline, day 7 and day 14

change from baseline of stride time assymetry

Time frame: baseline, day 7 and day 14

change from baseline of stride time

Time frame: baseline, day 7 and day 14

change from baseline of swing time

Time frame: baseline, day 7 and day 14

change from baseline of stance time

Time frame: baseline, day 7 and day 14

change from baseline of stride velocity

Time frame: baseline, day 7 and day 14