Neurologic DisorderProxiBlockNCT05519592
Proximal Lower Limb Intramuscular Block : Effects on Hemiparetic Gait
A study testing Ropivacaine injection and Sodium Chloride Injection in people with Neurologic Disorder and Spastic Hemiplegia, run by Henri Mondor University Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurologic Disorder, Spastic Hemiplegia, Gait, Hemiplegic
- What is being tested?
- Ropivacaine injection and Sodium Chloride Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 9 Sep 2022to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- able to consent
- avoiding ground swing phase gait disorder
Who cannot join
- severe cognitive disorder
- INR > 3.5
- local cutaneous affection on injection sites
- acute medical affection
- seizure
- hypersensitivity to anesthesics
Show all 11Show fewer
- brugada syndrome
- porphyria
- severe cardiac disorder
- polyradiculopathy
- botulinum toxin injection < 2 months
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Neurologic Disorder, Spastic Hemiplegia, Gait, Hemiplegic, Block
- Being tested
- Ropivacaine injection, Sodium Chloride Injection
- Medical subject headings
- Nervous System Diseases, Hemiplegia, Gait Disorders, Neurologic, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine injectionDrug
Intramuscular ropivacaine injection (gluteus maximus and rectus femoris)
Sodium Chloride InjectionDrug
Intramuscular sodium chloride injection (gluteus maximus and rectus femoris)
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Experimental | Ropivacaine intramuscular injection Receives: Drug: Ropivacaine injection |
| Control | Placebo comparator | Sodium Chlorure intramuscular injection Receives: Drug: Sodium Chloride Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of the active amplitude of hip flexion, knee flexion and ankle flexion
Measured: baseline, day 7 and day 14
Secondary outcomes (62)
change from baseline of the walking speed, at maximal speed, with shoes
Measured: baseline, day 7 and day 14
change from baseline of the walking speed, at maximal speed, without shoes
Measured: baseline, day 7 and day 14
change from baseline of the walking speed, at comfortable speed with shoes
Measured: baseline, day 7 and day 14
change from baseline of the walking speed, at comfortable speed without shoes
Measured: baseline, day 7 and day 14
change from baseline of the right step length, at maximal speed, with shoes
Measured: baseline, day 7 and day 14
change from baseline of the left step length, at maximal speed, with shoes
Measured: baseline, day 7 and day 14
change from baseline of the left step length, at maximal speed, without shoes
Measured: baseline, day 7 and day 14
change from baseline of the right step length, at maximal speed, without shoes
Measured: baseline, day 7 and day 14
change from baseline of the right step length, at comfortable speed, without shoes
Measured: baseline, day 7 and day 14
change from baseline of the right step length, at comfortable speed, with shoes
Measured: baseline, day 7 and day 14
change from baseline of the left step length, at comfortable speed, with shoes
Measured: baseline, day 7 and day 14
change from baseline of the left step length, at comfortable speed, without shoes
Measured: baseline, day 7 and day 14
change from baseline of the cadence (step per second), at comfortable speed, without shoes
Measured: baseline, day 7 and day 14
change from baseline of the cadence (step per second), at comfortable speed, with shoes
Measured: baseline, day 7 and day 14
change from baseline of the cadence (step per second), at maximal speed, with shoes
Measured: baseline, day 7 and day 14
change from baseline of the cadence (step per second), at maximal speed, without shoes
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: baseline, day 7 and day 14
change from baseline of spasticity (angle in degrees) of hamstrings
using the five steps assessment (Gracies JM)
Measured: baseline, day 7 and day 14
change from baseline of spasticity (angle in degrees) of gluteus maximus
using the five steps assessment (Gracies JM)
Measured: baseline, day 7 and day 14
change from baseline of spasticity (angle in degrees) of rectus femoris
using the five steps assessment (Gracies JM)
Measured: baseline, day 7 and day 14
change from baseline of spasticity (angle in degrees) of vastus
using the five steps assessment (Gracies JM)
Measured: baseline, day 7 and day 14
change from baseline of spasticity (angle in degrees) of soleus
using the five steps assessment (Gracies JM)
Measured: baseline, day 7 and day 14
change from baseline of spasticity (angle in degrees) of gastrocnemius
using the five steps assessment (Gracies JM)
Measured: baseline, day 7 and day 14
change from baseline of active amplitude against gastrocnemius
Measured: baseline, day 7 and day 14
change from baseline of active amplitude against soleus
Measured: baseline, day 7 and day 14
change from baseline of active amplitude against hamstrings
Measured: baseline, day 7 and day 14
change from baseline of active amplitude against gluteus maximus
Measured: baseline, day 7 and day 14
change from baseline of active amplitude against rectus femoris
Measured: baseline, day 7 and day 14
change from baseline of active amplitude against vastus
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: baseline, day 7 and day 14
change from baseline of patient global impression of improvement
GPI-I questionnaire
Measured: baseline, day 7 and day 14
change from baseline of right foot pressure distribution
Measured: baseline, day 7 and day 14
change from baseline of left foot pressure distribution
Measured: baseline, day 7 and day 14
change from baseline of left foot load
Measured: baseline, day 7 and day 14
change from baseline of right foot load
Measured: baseline, day 7 and day 14
change from baseline of stride velocity variability
Measured: baseline, day 7 and day 14
change from baseline of stride length variability
Measured: baseline, day 7 and day 14
change from baseline of stride time variability
Measured: baseline, day 7 and day 14
change from baseline of stance time variability
Measured: baseline, day 7 and day 14
change from baseline of double support time variability
Measured: baseline, day 7 and day 14
change from baseline of swing time assymetry
Measured: baseline, day 7 and day 14
change from baseline of stride time assymetry
Measured: baseline, day 7 and day 14
change from baseline of stride time
Measured: baseline, day 7 and day 14
change from baseline of swing time
Measured: baseline, day 7 and day 14
change from baseline of stance time
Measured: baseline, day 7 and day 14
change from baseline of stride velocity
Measured: baseline, day 7 and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start9 Sep 2022 (estimated)
- Primary completion2 May 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henri Mondor University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ETIENNE SAVARD, Henri Mondor University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519592
- Sponsor's protocol ID
- 2022-A01457-36
- Acronym
- ProxiBlock
- Status last verified
- Aug 2022
- First submitted
- 19 Aug 2022
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximal Lower Limb Intramuscular Block : Effects on Hemiparetic Gait
- ClinicalTrials.gov ID
- NCT05519592
- Acronym / sponsor ID
- ProxiBlock / 2022-A01457-36
- Conditions
- Neurologic Disorder, Spastic Hemiplegia, Gait, Hemiplegic, Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Henri Mondor University HospitalUniversity, hospital or other
- Study start
- 9 Sep 2022 (estimated)
- Primary completion
- 2 May 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | Experimental | Drug: Ropivacaine injectionRopivacaine intramuscular injection |
| Control | Placebo comparator | Drug: Sodium Chloride InjectionSodium Chlorure intramuscular injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- able to consent
- avoiding ground swing phase gait disorder
Key exclusion criteria (11 listed)
- severe cognitive disorder
- INR > 3.5
- local cutaneous affection on injection sites
- acute medical affection
- seizure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine injectionIntramuscular ropivacaine injection (gluteus maximus and rectus femoris) | Drug | Ropivacaine |
| Sodium Chloride InjectionIntramuscular sodium chloride injection (gluteus maximus and rectus femoris) | Drug | Control |
Primary outcome
Change from baseline of the active amplitude of hip flexion, knee flexion and ankle flexion
Time frame: baseline, day 7 and day 14
62 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
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)
Time frame: baseline, day 7 and day 14
change from baseline of Proprioception detection of hamstrings (minimal detectable change in degrees)
Time frame: baseline, day 7 and day 14
change from baseline of Proprioception detection of vastus (minimal detectable change in degrees)
Time frame: baseline, day 7 and day 14
change from baseline of Proprioception detection of rectus femoris (minimal detectable change in degrees)
Time frame: baseline, day 7 and day 14
change from baseline of Proprioception detection of soleus (minimal detectable change in degrees)
Time frame: baseline, day 7 and day 14
change from baseline of Proprioception detection of gastrocnemius (minimal detectable change in degrees)
Time frame: baseline, day 7 and day 14
change from baseline of Passive range of motion of gluteus maximus (muscle length in degrees)
Time frame: baseline, day 7 and day 14
change from baseline of Passive range of motion of rectus femoris (muscle length in degrees)
Time frame: baseline, day 7 and day 14
change from baseline of Passive range of motion of vastus (muscle length in degrees)
Time frame: baseline, day 7 and day 14
change from baseline of Passive range of motion of soleus (muscle length in degrees)
Time frame: baseline, day 7 and day 14
change from baseline of Passive range of motion of gastrocnemius (muscle length in degrees)
Time frame: baseline, day 7 and day 14
change from baseline of Passive range of motion of hamstrings (muscle length in degrees)
Time frame: baseline, day 7 and day 14
change from baseline of spasticity (angle in degrees) of hamstrings
Time frame: baseline, day 7 and day 14
change from baseline of spasticity (angle in degrees) of gluteus maximus
Time frame: baseline, day 7 and day 14
change from baseline of spasticity (angle in degrees) of rectus femoris
Time frame: baseline, day 7 and day 14
change from baseline of spasticity (angle in degrees) of vastus
Time frame: baseline, day 7 and day 14
change from baseline of spasticity (angle in degrees) of soleus
Time frame: baseline, day 7 and day 14
change from baseline of spasticity (angle in degrees) of gastrocnemius
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine injection and Sodium Chloride Injection in people with Neurologic Disorder and Spastic Hemiplegia, run by Henri Mondor University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact etienne savard (0033149813299, etienne.savard@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of the active amplitude of hip flexion, knee flexion and ankle flexion (time frame: baseline, day 7 and day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.