Proximal Lower Limb Intramuscular Block : Effects on Hemiparetic Gait (ProxiBlock)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neurologic Disorder; Gait, Hemiplegic; Block; Spastic Hemiplegia
• Intervention / Treatment: Drug: Ropivacaine injection; Drug: Sodium Chloride Injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: etienne savard; Phone Number: 0033149813299; Email: etienne.savard@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ropivacaine; Ropivacaine intramuscular injection	Drug: Ropivacaine injection; Intramuscular ropivacaine injection (gluteus maximus and rectus femoris)
Placebo Comparator: Control; Sodium Chlorure intramuscular injection	Drug: Sodium Chloride Injection; Intramuscular sodium chloride injection (gluteus maximus and rectus femoris)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline of the active amplitude of hip flexion, knee flexion and ankle flexion	baseline, day 7 and day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline of the walking speed, at maximal speed, with shoes		baseline, day 7 and day 14
change from baseline of the walking speed, at maximal speed, without shoes		baseline, day 7 and day 14
change from baseline of the walking speed, at comfortable speed with shoes		baseline, day 7 and day 14
change from baseline of the walking speed, at comfortable speed without shoes		baseline, day 7 and day 14
change from baseline of the right step length, at maximal speed, with shoes		baseline, day 7 and day 14
change from baseline of the left step length, at maximal speed, with shoes		baseline, day 7 and day 14
change from baseline of the left step length, at maximal speed, without shoes		baseline, day 7 and day 14
change from baseline of the right step length, at maximal speed, without shoes		baseline, day 7 and day 14
change from baseline of the right step length, at comfortable speed, without shoes		baseline, day 7 and day 14
change from baseline of the right step length, at comfortable speed, with shoes		baseline, day 7 and day 14
change from baseline of the left step length, at comfortable speed, with shoes		baseline, day 7 and day 14
change from baseline of the left step length, at comfortable speed, without shoes		baseline, day 7 and day 14
change from baseline of the cadence (step per second), at comfortable speed, without shoes		baseline, day 7 and day 14
change from baseline of the cadence (step per second), at comfortable speed, with shoes		baseline, day 7 and day 14
change from baseline of the cadence (step per second), at maximal speed, with shoes		baseline, day 7 and day 14
change from baseline of the cadence (step per second), at maximal speed, without shoes		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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	baseline, day 7 and day 14
change from baseline of spasticity (angle in degrees) of hamstrings	using the five steps assessment (Gracies JM)	baseline, day 7 and day 14
change from baseline of spasticity (angle in degrees) of gluteus maximus	using the five steps assessment (Gracies JM)	baseline, day 7 and day 14
change from baseline of spasticity (angle in degrees) of rectus femoris	using the five steps assessment (Gracies JM)	baseline, day 7 and day 14
change from baseline of spasticity (angle in degrees) of vastus	using the five steps assessment (Gracies JM)	baseline, day 7 and day 14
change from baseline of spasticity (angle in degrees) of soleus	using the five steps assessment (Gracies JM)	baseline, day 7 and day 14
change from baseline of spasticity (angle in degrees) of gastrocnemius	using the five steps assessment (Gracies JM)	baseline, day 7 and day 14
change from baseline of active amplitude against gastrocnemius		baseline, day 7 and day 14
change from baseline of active amplitude against soleus		baseline, day 7 and day 14
change from baseline of active amplitude against hamstrings		baseline, day 7 and day 14
change from baseline of active amplitude against gluteus maximus		baseline, day 7 and day 14
change from baseline of active amplitude against rectus femoris		baseline, day 7 and day 14
change from baseline of active amplitude against vastus		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)	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)	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)	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)	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)	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)	baseline, day 7 and day 14
change from baseline of patient global impression of improvement	GPI-I questionnaire	baseline, day 7 and day 14
change from baseline of right foot pressure distribution		baseline, day 7 and day 14
change from baseline of left foot pressure distribution		baseline, day 7 and day 14
change from baseline of left foot load		baseline, day 7 and day 14
change from baseline of right foot load		baseline, day 7 and day 14
change from baseline of stride velocity variability		baseline, day 7 and day 14
change from baseline of stride length variability		baseline, day 7 and day 14
change from baseline of stride time variability		baseline, day 7 and day 14
change from baseline of stance time variability		baseline, day 7 and day 14
change from baseline of double support time variability		baseline, day 7 and day 14
change from baseline of swing time assymetry		baseline, day 7 and day 14
change from baseline of stride time assymetry		baseline, day 7 and day 14
change from baseline of stride time		baseline, day 7 and day 14
change from baseline of swing time		baseline, day 7 and day 14
change from baseline of stance time		baseline, day 7 and day 14
change from baseline of stride velocity		baseline, day 7 and day 14

Collaborators and Investigators

• Sponsor: Henri Mondor University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 9, 2022
• Primary Completion (Anticipated): May 2, 2023
• Study Completion (Anticipated): October 30, 2023

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Paralysis; Nervous System Diseases; Hemiplegia; Gait Disorders, Neurologic; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 2022-A01457-36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No