Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-01-01 @ 10:34 AM
Study NCT ID:
NCT06327035
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evolution of Walking Abilities in Subacute Stroke Patients Hospitalized in Neurorehabilitation Center
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D020233', 'term': 'Gait Disorders, Neurologic'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-21', 'studyFirstSubmitDate': '2024-03-15', 'studyFirstSubmitQcDate': '2024-03-21', 'lastUpdatePostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Ambulation Classification', 'timeFrame': 'Functional Ambulation Classification will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).', 'description': 'The Functional Ambulation Categories (FAC) is a 6-point functional walking test that evaluates ambulation ability.'}], 'secondaryOutcomes': [{'measure': 'Postural Assesment Scale for Stroke Patient', 'timeFrame': 'Postural Assesment Scale for Stroke Patient will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).', 'description': 'The Postural Assessment Scale for Stroke Patients (PASS) assesses balance in lying, sitting and standing positions. It was designed specifically for patients with stroke and is suitable for all individuals regardless of postural performance.\n\nThe PASS consists of a 4-point scale where items are scored from 0 - 3. The total score ranges from 0 - 36, the higher the score is, the more favourable the balance in stroke patients.'}, {'measure': 'Timed Up and Go', 'timeFrame': 'Timed Up and Go will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).', 'description': 'The Timed Up and Go is a general physical performance test used to assess mobility, balance and locomotor performance. More specifically, it assesses the ability to perform sequential motor tasks relative to walking and turning.'}, {'measure': '10-Meter Walk Test', 'timeFrame': '10-Meter Walk Test will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).', 'description': 'The 10 Metre Walk Test is a performance measure used to assess walking speed in meters per second over a short distance'}, {'measure': '6Minute-Walk Test', 'timeFrame': '6Minute-Walk Test will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).', 'description': 'The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.'}, {'measure': 'Motricity Index', 'timeFrame': 'Motricity Index will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).', 'description': 'The Motricity Index (MI) is an ordinal method of measuring limb strength. The total score ranges from 0 - 100, with the higher numbers representing good muscle strength.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'lower limb', 'gait recovery', 'balance'], 'conditions': ['Stroke', 'Gait, Hemiplegic']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to describe the evolution of gait recovery during the subacute phase of stroke up to six months after stroke, in patients hospitalized in medical and neurological rehabilitation units.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Stroke patient hospitalized in one of the investigating centers during acute/subacute phase.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient hospitalized in one of the investigating centers after acute/subacute stroke.\n* Affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Opposed to its participation in this study\n* Neurodegenerative disease impacting gait prior to stroke onset\n* Patient not walking before stroke\n* Progressive pathology with life-threatening consequences within 6 months\n* Patient under legal protection'}, 'identificationModule': {'nctId': 'NCT06327035', 'acronym': 'PROWALK', 'briefTitle': 'Evolution of Walking Abilities in Subacute Stroke Patients Hospitalized in Neurorehabilitation Center', 'organization': {'class': 'OTHER', 'fullName': 'Clinique Les Trois Soleils'}, 'officialTitle': 'Neurological Recovery of the Paretic Lower Limb and Balance and Walking Abilities in the Subacute Phase of Stroke in Patients Hospitalized in Medical and Rehabilitation Units: A Prospective Multicenter Longitudinal Study', 'orgStudyIdInfo': {'id': '2023-A02660-45'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Gait rehabilitation', 'type': 'OTHER', 'description': 'Assessment of gait and balance abilities after stroke during neurorehabilitation from the subacute phase of stroke to 6 months after stroke.\n\nThe assessments will be carried out on entrance to the neurological center, then at 1 ,3 and 6 months and on hospital discharge.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '50400', 'city': 'Granville', 'state': 'Normandy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne Peskine, MD', 'role': 'CONTACT', 'email': 'apeskine.normandy@lna-sante.com', 'phone': '+33233903333'}, {'name': 'Soizic Injeyan, PT', 'role': 'CONTACT', 'email': 'dirmissions.normandy@lna-sante.com', 'phone': '+33233903333'}], 'facility': 'Le Normandy', 'geoPoint': {'lat': 48.83792, 'lon': -1.59714}}, {'zip': '77310', 'city': 'Boissise-le-Roi', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christophe Duret, MD', 'role': 'CONTACT', 'email': 'ch.duret@les-trois-soleils.fr'}, {'name': 'Christophe Duret, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique Les Trois Soleils', 'geoPoint': {'lat': 48.52479, 'lon': 2.56971}}, {'zip': '77310', 'city': 'Boissise-le-Roi', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ophélie Pila, PhD', 'role': 'CONTACT'}, {'name': 'Christophe Duret, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Anne Peskine, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'La Clinique Les Trois Soleils', 'geoPoint': {'lat': 48.52479, 'lon': 2.56971}}], 'centralContacts': [{'name': 'Anne-Gaëlle Grosmaire', 'role': 'CONTACT', 'email': 'ag.grosmaire@les-trois-soleils.fr', 'phone': '+33164717372'}, {'name': 'Ophélie Pila, Phd', 'role': 'CONTACT', 'email': 'o.pila@les-trois-soleils.fr'}], 'overallOfficials': [{'name': 'Christophe T Duret, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Les Trois Soleils'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique Les Trois Soleils', 'class': 'OTHER'}, 'collaborators': [{'name': 'Le Normandy', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}