Proximal Lower Limb Intramuscular Block : Effects on Hemiparetic Gait

Neurologic Disorder Clinical Trial

— ProxiBlock  

Official title:

Proximal Lower Limb Intramuscular Block : Effects on Hemiparetic Gait

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05519592
• Other study ID #: 2022-A01457-36
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 9, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: August 2022
• Source: Henri Mondor University Hospital
• Contact: etienne savard
• Phone: 0033149813299
• Email: etienne.savard[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 30, 2023
• Est. primary completion date: May 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Block
• Gait Disorders, Neurologic
• Gait, Hemiplegic
• Hemiplegia
• Nervous System Diseases
• Neurologic Disorder
• Spastic Hemiplegia

Intervention

Drug:
• Ropivacaine injection
Intramuscular ropivacaine injection (gluteus maximus and rectus femoris)
• Sodium Chloride Injection
Intramuscular sodium chloride injection (gluteus maximus and rectus femoris)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henri Mondor University Hospital

Outcome

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