Clinical trial NCT05519592: Proximal Lower Limb Intramuscular Block : Effects on Hemiparetic Gait
Official title: Proximal Lower Limb Intramuscular Block : Effects on Hemiparetic Gait
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neurologic Disorder
Spastic Hemiplegia
Gait, Hemiplegic
Block
Lead sponsor: Henri Mondor University Hospital
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline of the active amplitude of hip flexion, knee flexion and ankle flexion
timeFrame: baseline, day 7 and day 14
Secondary outcomes:
measure: change from baseline of the walking speed, at maximal speed, with shoes
timeFrame: baseline, day 7 and day 14
measure: change from baseline of the walking speed, at maximal speed, without shoes
timeFrame: baseline, day 7 and day 14
measure: change from baseline of the walking speed, at comfortable speed with shoes
timeFrame: baseline, day 7 and day 14
measure: change from baseline of the walking speed, at comfortable speed without shoes
timeFrame: baseline, day 7 and day 14
measure: change from baseline of the right step length, at maximal speed, with shoes
timeFrame: baseline, day 7 and day 14
measure: change from baseline of the left step length, at maximal speed, with shoes
timeFrame: baseline, day 7 and day 14
measure: change from baseline of the left step length, at maximal speed, without shoes
timeFrame: baseline, day 7 and day 14
measure: change from baseline of the right step length, at maximal speed, without shoes
timeFrame: baseline, day 7 and day 14
measure: change from baseline of the right step length, at comfortable speed, without shoes
timeFrame: baseline, day 7 and day 14
measure: change from baseline of the right step length, at comfortable speed, with shoes
timeFrame: baseline, day 7 and day 14
measure: change from baseline of the left step length, at comfortable speed, with shoes
timeFrame: baseline, day 7 and day 14
measure: change from baseline of the left step length, at comfortable speed, without shoes
timeFrame: baseline, day 7 and day 14
measure: change from baseline of the cadence (step per second), at comfortable speed, without shoes
timeFrame: baseline, day 7 and day 14
measure: change from baseline of the cadence (step per second), at comfortable speed, with shoes
timeFrame: baseline, day 7 and day 14
measure: change from baseline of the cadence (step per second), at maximal speed, with shoes
timeFrame: baseline, day 7 and day 14
measure: change from baseline of the cadence (step per second), at maximal speed, without shoes
timeFrame: baseline, day 7 and day 14
measure: change from baseline of Proprioception detection of gluteus maximus (minimal detectable change in degrees)
timeFrame: baseline, day 7 and day 14
measure: change from baseline of Proprioception detection of hamstrings (minimal detectable change in degrees)
timeFrame: baseline, day 7 and day 14
measure: change from baseline of Proprioception detection of vastus (minimal detectable change in degrees)
timeFrame: baseline, day 7 and day 14
measure: change from baseline of Proprioception detection of rectus femoris (minimal detectable change in degrees)
timeFrame: baseline, day 7 and day 14
measure: change from baseline of Proprioception detection of soleus (minimal detectable change in degrees)
timeFrame: baseline, day 7 and day 14
measure: change from baseline of Proprioception detection of gastrocnemius (minimal detectable change in degrees)
timeFrame: baseline, day 7 and day 14
measure: change from baseline of Passive range of motion of gluteus maximus (muscle length in degrees)
timeFrame: baseline, day 7 and day 14
measure: change from baseline of Passive range of motion of rectus femoris (muscle length in degrees)
timeFrame: baseline, day 7 and day 14
measure: change from baseline of Passive range of motion of vastus (muscle length in degrees)
timeFrame: baseline, day 7 and day 14
measure: change from baseline of Passive range of motion of soleus (muscle length in degrees)
timeFrame: baseline, day 7 and day 14
measure: change from baseline of Passive range of motion of gastrocnemius (muscle length in degrees)
timeFrame: baseline, day 7 and day 14
measure: change from baseline of Passive range of motion of hamstrings (muscle length in degrees)
timeFrame: baseline, day 7 and day 14
measure: change from baseline of spasticity (angle in degrees) of hamstrings
timeFrame: baseline, day 7 and day 14
measure: change from baseline of spasticity (angle in degrees) of gluteus maximus
timeFrame: baseline, day 7 and day 14
measure: change from baseline of spasticity (angle in degrees) of rectus femoris
timeFrame: baseline, day 7 and day 14
measure: change from baseline of spasticity (angle in degrees) of vastus
timeFrame: baseline, day 7 and day 14
measure: change from baseline of spasticity (angle in degrees) of soleus
timeFrame: baseline, day 7 and day 14
measure: change from baseline of spasticity (angle in degrees) of gastrocnemius
timeFrame: baseline, day 7 and day 14
measure: change from baseline of active amplitude against gastrocnemius
timeFrame: baseline, day 7 and day 14
measure: change from baseline of active amplitude against soleus
timeFrame: baseline, day 7 and day 14
measure: change from baseline of active amplitude against hamstrings
timeFrame: baseline, day 7 and day 14
measure: change from baseline of active amplitude against gluteus maximus
timeFrame: baseline, day 7 and day 14
measure: change from baseline of active amplitude against rectus femoris
timeFrame: baseline, day 7 and day 14
measure: change from baseline of active amplitude against vastus
timeFrame: baseline, day 7 and day 14
measure: change from baseline of fatigability against vastus (in degrees, after 15 second of alternative movement)
timeFrame: baseline, day 7 and day 14
measure: change from baseline of fatigability against rectus femoris (in degrees, after 15 second of alternative movement)
timeFrame: baseline, day 7 and day 14
measure: change from baseline of fatigability against gluteus maximus (in degrees, after 15 second of alternative movement)
timeFrame: baseline, day 7 and day 14
measure: change from baseline of fatigability against hamstrings (in degrees, after 15 second of alternative movement)
timeFrame: baseline, day 7 and day 14
measure: change from baseline of fatigability against gastrocnemius (in degrees, after 15 second of alternative movement)
timeFrame: baseline, day 7 and day 14
measure: change from baseline of fatigability against soleus (in degrees, after 15 second of alternative movement)
timeFrame: baseline, day 7 and day 14
measure: change from baseline of patient global impression of improvement
timeFrame: baseline, day 7 and day 14
measure: change from baseline of right foot pressure distribution
timeFrame: baseline, day 7 and day 14
measure: change from baseline of left foot pressure distribution
timeFrame: baseline, day 7 and day 14
measure: change from baseline of left foot load
timeFrame: baseline, day 7 and day 14
measure: change from baseline of right foot load
timeFrame: baseline, day 7 and day 14
measure: change from baseline of stride velocity variability
timeFrame: baseline, day 7 and day 14
measure: change from baseline of stride length variability
timeFrame: baseline, day 7 and day 14
measure: change from baseline of stride time variability
timeFrame: baseline, day 7 and day 14
measure: change from baseline of stance time variability
timeFrame: baseline, day 7 and day 14
measure: change from baseline of double support time variability
timeFrame: baseline, day 7 and day 14
measure: change from baseline of swing time assymetry
timeFrame: baseline, day 7 and day 14
measure: change from baseline of stride time assymetry
timeFrame: baseline, day 7 and day 14
measure: change from baseline of stride time
timeFrame: baseline, day 7 and day 14
measure: change from baseline of swing time
timeFrame: baseline, day 7 and day 14
measure: change from baseline of stance time
timeFrame: baseline, day 7 and day 14
measure: change from baseline of stride velocity
timeFrame: baseline, day 7 and day 14
Other outcomes:
Locations:
Study officials:
References: