Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-26 @ 11:33 AM
Study NCT ID:
NCT05519592
Status:
UNKNOWN
Last Update Posted:
2022-08-29
First Post:
2022-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proximal Lower Limb Intramuscular Block : Effects on Hemiparetic Gait
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006429', 'term': 'Hemiplegia'}, {'id': 'D020233', 'term': 'Gait Disorders, Neurologic'}, {'id': 'D001733', 'term': 'Bites and Stings'}], 'ancestors': [{'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-25', 'studyFirstSubmitDate': '2022-08-19', 'studyFirstSubmitQcDate': '2022-08-25', 'lastUpdatePostDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline of the active amplitude of hip flexion, knee flexion and ankle flexion', 'timeFrame': 'baseline, day 7 and day 14'}], 'secondaryOutcomes': [{'measure': 'change from baseline of the walking speed, at maximal speed, with shoes', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of the walking speed, at maximal speed, without shoes', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of the walking speed, at comfortable speed with shoes', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of the walking speed, at comfortable speed without shoes', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of the right step length, at maximal speed, with shoes', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of the left step length, at maximal speed, with shoes', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of the left step length, at maximal speed, without shoes', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of the right step length, at maximal speed, without shoes', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of the right step length, at comfortable speed, without shoes', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of the right step length, at comfortable speed, with shoes', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of the left step length, at comfortable speed, with shoes', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of the left step length, at comfortable speed, without shoes', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of the cadence (step per second), at comfortable speed, without shoes', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of the cadence (step per second), at comfortable speed, with shoes', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of the cadence (step per second), at maximal speed, with shoes', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of the cadence (step per second), at maximal speed, without shoes', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of Proprioception detection of gluteus maximus (minimal detectable change in degrees)', 'timeFrame': 'baseline, day 7 and day 14', 'description': 'using the five steps assessment (Gracies JM)'}, {'measure': 'change from baseline of Proprioception detection of hamstrings (minimal detectable change in degrees)', 'timeFrame': 'baseline, day 7 and day 14', 'description': 'using the five steps assessment (Gracies JM)'}, {'measure': 'change from baseline of Proprioception detection of vastus (minimal detectable change in degrees)', 'timeFrame': 'baseline, day 7 and day 14', 'description': 'using the five steps assessment (Gracies JM)'}, {'measure': 'change from baseline of Proprioception detection of rectus femoris (minimal detectable change in degrees)', 'timeFrame': 'baseline, day 7 and day 14', 'description': 'using the five steps assessment (Gracies JM)'}, {'measure': 'change from baseline of Proprioception detection of soleus (minimal detectable change in degrees)', 'timeFrame': 'baseline, day 7 and day 14', 'description': 'using the five steps assessment (Gracies JM)'}, {'measure': 'change from baseline of Proprioception detection of gastrocnemius (minimal detectable change in degrees)', 'timeFrame': 'baseline, day 7 and day 14', 'description': 'using the five steps assessment (Gracies JM)'}, {'measure': 'change from baseline of Passive range of motion of gluteus maximus (muscle length in degrees)', 'timeFrame': 'baseline, day 7 and day 14', 'description': 'using the five steps assessment (Gracies JM)'}, {'measure': 'change from baseline of Passive range of motion of rectus femoris (muscle length in degrees)', 'timeFrame': 'baseline, day 7 and day 14', 'description': 'using the five steps assessment (Gracies JM)'}, {'measure': 'change from baseline of Passive range of motion of vastus (muscle length in degrees)', 'timeFrame': 'baseline, day 7 and day 14', 'description': 'using the five steps assessment (Gracies JM)'}, {'measure': 'change from baseline of Passive range of motion of soleus (muscle length in degrees)', 'timeFrame': 'baseline, day 7 and day 14', 'description': 'using the five steps assessment (Gracies JM)'}, {'measure': 'change from baseline of Passive range of motion of gastrocnemius (muscle length in degrees)', 'timeFrame': 'baseline, day 7 and day 14', 'description': 'using the five steps assessment (Gracies JM)'}, {'measure': 'change from baseline of Passive range of motion of hamstrings (muscle length in degrees)', 'timeFrame': 'baseline, day 7 and day 14', 'description': 'using the five steps assessment (Gracies JM)'}, {'measure': 'change from baseline of spasticity (angle in degrees) of hamstrings', 'timeFrame': 'baseline, day 7 and day 14', 'description': 'using the five steps assessment (Gracies JM)'}, {'measure': 'change from baseline of spasticity (angle in degrees) of gluteus maximus', 'timeFrame': 'baseline, day 7 and day 14', 'description': 'using the five steps assessment (Gracies JM)'}, {'measure': 'change from baseline of spasticity (angle in degrees) of rectus femoris', 'timeFrame': 'baseline, day 7 and day 14', 'description': 'using the five steps assessment (Gracies JM)'}, {'measure': 'change from baseline of spasticity (angle in degrees) of vastus', 'timeFrame': 'baseline, day 7 and day 14', 'description': 'using the five steps assessment (Gracies JM)'}, {'measure': 'change from baseline of spasticity (angle in degrees) of soleus', 'timeFrame': 'baseline, day 7 and day 14', 'description': 'using the five steps assessment (Gracies JM)'}, {'measure': 'change from baseline of spasticity (angle in degrees) of gastrocnemius', 'timeFrame': 'baseline, day 7 and day 14', 'description': 'using the five steps assessment (Gracies JM)'}, {'measure': 'change from baseline of active amplitude against gastrocnemius', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of active amplitude against soleus', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of active amplitude against hamstrings', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of active amplitude against gluteus maximus', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of active amplitude against rectus femoris', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of active amplitude against vastus', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of fatigability against vastus (in degrees, after 15 second of alternative movement)', 'timeFrame': 'baseline, day 7 and day 14', 'description': 'using the five steps assessment (Gracies JM)'}, {'measure': 'change from baseline of fatigability against rectus femoris (in degrees, after 15 second of alternative movement)', 'timeFrame': 'baseline, day 7 and day 14', 'description': 'using the five steps assessment (Gracies JM)'}, {'measure': 'change from baseline of fatigability against gluteus maximus (in degrees, after 15 second of alternative movement)', 'timeFrame': 'baseline, day 7 and day 14', 'description': 'using the five steps assessment (Gracies JM)'}, {'measure': 'change from baseline of fatigability against hamstrings (in degrees, after 15 second of alternative movement)', 'timeFrame': 'baseline, day 7 and day 14', 'description': 'using the five steps assessment (Gracies JM)'}, {'measure': 'change from baseline of fatigability against gastrocnemius (in degrees, after 15 second of alternative movement)', 'timeFrame': 'baseline, day 7 and day 14', 'description': 'using the five steps assessment (Gracies JM)'}, {'measure': 'change from baseline of fatigability against soleus (in degrees, after 15 second of alternative movement)', 'timeFrame': 'baseline, day 7 and day 14', 'description': 'using the five steps assessment (Gracies JM)'}, {'measure': 'change from baseline of patient global impression of improvement', 'timeFrame': 'baseline, day 7 and day 14', 'description': 'GPI-I questionnaire'}, {'measure': 'change from baseline of right foot pressure distribution', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of left foot pressure distribution', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of left foot load', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of right foot load', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of stride velocity variability', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of stride length variability', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of stride time variability', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of stance time variability', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of double support time variability', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of swing time assymetry', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of stride time assymetry', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of stride time', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of swing time', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of stance time', 'timeFrame': 'baseline, day 7 and day 14'}, {'measure': 'change from baseline of stride velocity', 'timeFrame': 'baseline, day 7 and day 14'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neurologic Disorder', 'Spastic Hemiplegia', 'Gait, Hemiplegic', 'Block']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAbout 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* able to consent\n* avoiding ground swing phase gait disorder\n\nExclusion Criteria:\n\n* severe cognitive disorder\n* INR \\> 3.5\n* local cutaneous affection on injection sites\n* acute medical affection\n* seizure\n* hypersensitivity to anesthesics\n* brugada syndrome\n* porphyria\n* severe cardiac disorder\n* polyradiculopathy\n* botulinum toxin injection \\< 2 months'}, 'identificationModule': {'nctId': 'NCT05519592', 'acronym': 'ProxiBlock', 'briefTitle': 'Proximal Lower Limb Intramuscular Block : Effects on Hemiparetic Gait', 'organization': {'class': 'OTHER', 'fullName': 'Henri Mondor University Hospital'}, 'officialTitle': 'Proximal Lower Limb Intramuscular Block : Effects on Hemiparetic Gait', 'orgStudyIdInfo': {'id': '2022-A01457-36'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ropivacaine', 'description': 'Ropivacaine intramuscular injection', 'interventionNames': ['Drug: Ropivacaine injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Sodium Chlorure intramuscular injection', 'interventionNames': ['Drug: Sodium Chloride Injection']}], 'interventions': [{'name': 'Ropivacaine injection', 'type': 'DRUG', 'description': 'Intramuscular ropivacaine injection (gluteus maximus and rectus femoris)', 'armGroupLabels': ['Ropivacaine']}, {'name': 'Sodium Chloride Injection', 'type': 'DRUG', 'description': 'Intramuscular sodium chloride injection (gluteus maximus and rectus femoris)', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'etienne savard', 'role': 'CONTACT', 'email': 'etienne.savard@aphp.fr', 'phone': '0033149813299'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henri Mondor University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hospital Practictioner', 'investigatorFullName': 'ETIENNE SAVARD', 'investigatorAffiliation': 'Henri Mondor University Hospital'}}}}