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

Primary Purpose

Neurologic Disorder, Spastic Hemiplegia, Gait, Hemiplegic

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Ropivacaine injection

Sodium Chloride Injection

About this trial

This is an interventional health services research trial for Neurologic Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ropivacaine

Control

Arm Description

Ropivacaine intramuscular injection

Sodium Chlorure intramuscular injection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

using the five steps assessment (Gracies JM)

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

using the five steps assessment (Gracies JM)

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

using the five steps assessment (Gracies JM)

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

using the five steps assessment (Gracies JM)

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

using the five steps assessment (Gracies JM)

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

using the five steps assessment (Gracies JM)

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

using the five steps assessment (Gracies JM)

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

using the five steps assessment (Gracies JM)

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

using the five steps assessment (Gracies JM)

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

using the five steps assessment (Gracies JM)

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

using the five steps assessment (Gracies JM)

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

using the five steps assessment (Gracies JM)

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

using the five steps assessment (Gracies JM)

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

using the five steps assessment (Gracies JM)

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

using the five steps assessment (Gracies JM)

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

using the five steps assessment (Gracies JM)

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

using the five steps assessment (Gracies JM)

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

using the five steps assessment (Gracies JM)

change from baseline of active amplitude against gastrocnemius

change from baseline of active amplitude against soleus

change from baseline of active amplitude against hamstrings

change from baseline of active amplitude against gluteus maximus

change from baseline of active amplitude against rectus femoris

change from baseline of active amplitude against vastus

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

using the five steps assessment (Gracies JM)

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

using the five steps assessment (Gracies JM)

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

using the five steps assessment (Gracies JM)

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

using the five steps assessment (Gracies JM)

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

using the five steps assessment (Gracies JM)

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

using the five steps assessment (Gracies JM)

change from baseline of patient global impression of improvement

GPI-I questionnaire

change from baseline of right foot pressure distribution

change from baseline of left foot pressure distribution

change from baseline of left foot load

change from baseline of right foot load

change from baseline of stride velocity variability

change from baseline of stride length variability

change from baseline of stride time variability

change from baseline of stance time variability

change from baseline of double support time variability

change from baseline of swing time assymetry

change from baseline of stride time assymetry

change from baseline of stride time

change from baseline of swing time

change from baseline of stance time

change from baseline of stride velocity

Full Information

NCT ID

NCT05519592

First Posted

August 19, 2022

Last Updated

August 25, 2022

Sponsor

Henri Mondor University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05519592

Brief Title

Proximal Lower Limb Intramuscular Block : Effects on Hemiparetic Gait

Acronym

ProxiBlock

Official Title

Proximal Lower Limb Intramuscular Block : Effects on Hemiparetic Gait

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 9, 2022 (Anticipated)

Primary Completion Date

May 2, 2023 (Anticipated)

Study Completion Date

October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Henri Mondor University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neurologic Disorder, Spastic Hemiplegia, Gait, Hemiplegic, Block

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ropivacaine

Arm Type

Experimental

Arm Description

Ropivacaine intramuscular injection

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

Sodium Chlorure intramuscular injection

Intervention Type

Drug

Intervention Name(s)

Ropivacaine injection

Intervention Description

Intramuscular ropivacaine injection (gluteus maximus and rectus femoris)

Intervention Type

Drug

Intervention Name(s)

Sodium Chloride Injection

Intervention Description

Intramuscular sodium chloride injection (gluteus maximus and rectus femoris)

Primary Outcome Measure Information:

Title

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

Time Frame

baseline, day 7 and day 14

Secondary Outcome Measure Information:

Title

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

Time Frame

baseline, day 7 and day 14

Title

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

Time Frame

baseline, day 7 and day 14

Title

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

Time Frame

baseline, day 7 and day 14

Title

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

Time Frame

baseline, day 7 and day 14

Title

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

Time Frame

baseline, day 7 and day 14

Title

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

Time Frame

baseline, day 7 and day 14

Title

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

Time Frame

baseline, day 7 and day 14

Title

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

Time Frame

baseline, day 7 and day 14

Title

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

Time Frame

baseline, day 7 and day 14

Title

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

Time Frame

baseline, day 7 and day 14

Title

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

Time Frame

baseline, day 7 and day 14

Title

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

Time Frame

baseline, day 7 and day 14

Title

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

Time Frame

baseline, day 7 and day 14

Title

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

Time Frame

baseline, day 7 and day 14

Title

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

Time Frame

baseline, day 7 and day 14

Title

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

Time Frame

baseline, day 7 and day 14

Title

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

Description

using the five steps assessment (Gracies JM)

Time Frame

baseline, day 7 and day 14

Title

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

Description

using the five steps assessment (Gracies JM)

Time Frame

baseline, day 7 and day 14

Title

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

Description

using the five steps assessment (Gracies JM)

Time Frame

baseline, day 7 and day 14

Title

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

Description

using the five steps assessment (Gracies JM)

Time Frame

baseline, day 7 and day 14

Title

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

Description

using the five steps assessment (Gracies JM)

Time Frame

baseline, day 7 and day 14

Title

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

Description

using the five steps assessment (Gracies JM)

Time Frame

baseline, day 7 and day 14

Title

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

Description

using the five steps assessment (Gracies JM)

Time Frame

baseline, day 7 and day 14

Title

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

Description

using the five steps assessment (Gracies JM)

Time Frame

baseline, day 7 and day 14

Title

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

Description

using the five steps assessment (Gracies JM)

Time Frame

baseline, day 7 and day 14

Title

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

Description

using the five steps assessment (Gracies JM)

Time Frame

baseline, day 7 and day 14

Title

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

Description

using the five steps assessment (Gracies JM)

Time Frame

baseline, day 7 and day 14

Title

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

Description

using the five steps assessment (Gracies JM)

Time Frame

baseline, day 7 and day 14

Title

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

Description

using the five steps assessment (Gracies JM)

Time Frame

baseline, day 7 and day 14

Title

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

Description

using the five steps assessment (Gracies JM)

Time Frame

baseline, day 7 and day 14

Title

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

Description

using the five steps assessment (Gracies JM)

Time Frame

baseline, day 7 and day 14

Title

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

Description

using the five steps assessment (Gracies JM)

Time Frame

baseline, day 7 and day 14

Title

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

Description

using the five steps assessment (Gracies JM)

Time Frame

baseline, day 7 and day 14

Title

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

Description

using the five steps assessment (Gracies JM)

Time Frame

baseline, day 7 and day 14

Title

change from baseline of active amplitude against gastrocnemius

Time Frame

baseline, day 7 and day 14

Title

change from baseline of active amplitude against soleus

Time Frame

baseline, day 7 and day 14

Title

change from baseline of active amplitude against hamstrings

Time Frame

baseline, day 7 and day 14

Title

change from baseline of active amplitude against gluteus maximus

Time Frame

baseline, day 7 and day 14

Title

change from baseline of active amplitude against rectus femoris

Time Frame

baseline, day 7 and day 14

Title

change from baseline of active amplitude against vastus

Time Frame

baseline, day 7 and day 14

Title

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

Description

using the five steps assessment (Gracies JM)

Time Frame

baseline, day 7 and day 14

Title

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

Description

using the five steps assessment (Gracies JM)

Time Frame

baseline, day 7 and day 14

Title

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

Description

using the five steps assessment (Gracies JM)

Time Frame

baseline, day 7 and day 14

Title

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

Description

using the five steps assessment (Gracies JM)

Time Frame

baseline, day 7 and day 14

Title

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

Description

using the five steps assessment (Gracies JM)

Time Frame

baseline, day 7 and day 14

Title

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

Description

using the five steps assessment (Gracies JM)

Time Frame

baseline, day 7 and day 14

Title

change from baseline of patient global impression of improvement

Description

GPI-I questionnaire

Time Frame

baseline, day 7 and day 14

Title

change from baseline of right foot pressure distribution

Time Frame

baseline, day 7 and day 14

Title

change from baseline of left foot pressure distribution

Time Frame

baseline, day 7 and day 14

Title

change from baseline of left foot load

Time Frame

baseline, day 7 and day 14

Title

change from baseline of right foot load

Time Frame

baseline, day 7 and day 14

Title

change from baseline of stride velocity variability

Time Frame

baseline, day 7 and day 14

Title

change from baseline of stride length variability

Time Frame

baseline, day 7 and day 14

Title

change from baseline of stride time variability

Time Frame

baseline, day 7 and day 14

Title

change from baseline of stance time variability

Time Frame

baseline, day 7 and day 14

Title

change from baseline of double support time variability

Time Frame

baseline, day 7 and day 14

Title

change from baseline of swing time assymetry

Time Frame

baseline, day 7 and day 14

Title

change from baseline of stride time assymetry

Time Frame

baseline, day 7 and day 14

Title

change from baseline of stride time

Time Frame

baseline, day 7 and day 14

Title

change from baseline of swing time

Time Frame

baseline, day 7 and day 14

Title

change from baseline of stance time

Time Frame

baseline, day 7 and day 14

Title

change from baseline of stride velocity

Time Frame

baseline, day 7 and day 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

etienne savard

Phone

0033149813299

etienne.savard@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Proximal Lower Limb Intramuscular Block : Effects on Hemiparetic Gait

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