Proximal Lower Limb Intramuscular Block : Effects on Hemiparetic Gait
ProxiBlock
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2022
CompletedFirst Posted
Study publicly available on registry
August 29, 2022
CompletedStudy Start
First participant enrolled
September 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2023
CompletedAugust 29, 2022
August 1, 2022
8 months
August 19, 2022
August 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline of the active amplitude of hip flexion, knee flexion and ankle flexion
baseline, day 7 and day 14
Secondary Outcomes (62)
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
- +57 more secondary outcomes
Study Arms (2)
Ropivacaine
EXPERIMENTALRopivacaine intramuscular injection
Control
PLACEBO COMPARATORSodium Chlorure intramuscular injection
Interventions
Intramuscular ropivacaine injection (gluteus maximus and rectus femoris)
Intramuscular sodium chloride injection (gluteus maximus and rectus femoris)
Eligibility Criteria
You may qualify if:
- able to consent
- avoiding ground swing phase gait disorder
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Hospital Practictioner
Study Record Dates
First Submitted
August 19, 2022
First Posted
August 29, 2022
Study Start
September 9, 2022
Primary Completion
May 2, 2023
Study Completion
October 30, 2023
Last Updated
August 29, 2022
Record last verified: 2022-08