Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-03-02 @ 3:59 PM
Study NCT ID:
NCT02263560
Status:
COMPLETED
Last Update Posted:
2017-10-25
First Post:
2014-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supraspinal Contributions to the Control of Human Locomotion: Clinical and Fundamental Aspects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-24', 'studyFirstSubmitDate': '2014-10-06', 'studyFirstSubmitQcDate': '2014-10-08', 'lastUpdatePostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Walking stability indices of post-stroke patients', 'timeFrame': '1 hour and 30 minutes (including pre-tests, instructions delivery...).'}, {'measure': 'Spatial accuracy of walking trajectories in post-stroke patients', 'timeFrame': '1 hour and 30 minutes (including pre-tests, instructions delivery...).'}]}, 'conditionsModule': {'conditions': ['Post-stroke Gait Assessments']}, 'descriptionModule': {'briefSummary': 'Many neurological patients express enhanced deficits while walking in a dark room (or during the night): the supraspinal structures involved in this navigational deficit have not been identified yet. In this project, the investigators will study post-stroke gaits of human patients and compare them to those of a control population during a goal-oriented task performed in different visual conditions.\n\nThe investigators want to test the hypothesis that during simple goal-oriented locomotor tasks, only patients with specific (e.g. medio or infero- temporal) lesions will express navigational deficits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The selected patients will be described by following parameters:\n\n* Parameters in relation to the person: age, gender.\n* Parameters in relation to the pathology: NIHSS, exact localisation, time since start of the symptoms, FIM (functional independence measure) visual field (ophthalmological examen), visual acuity (ophtalmological examen), visual neglect (Bells Cancellation Task), visuo-spatial short term working memory (Corsi span), visual motor integration (3-D cub subtest MoCA)\n* Parameters in relation to hospital stay: length of stay.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (for matching controls):\n\n* Adult male and female subjects (18--\\>85 years old)\n\nExclusion Criteria (for matching controls):\n\n* Persons with history of an acquired or congenital neurological disorder, e.g. stroke, multiple sclerosis, Parkinson disease, increased intracranial pressure, etc.;\n* Persons injured at the time of the experiments (fractures,…);\n* Persons having reported repetitive spatial troubles/disorders;\n* Persons with eye disorders and non-corrected vision problems;\n* Pregnant women.'}, 'identificationModule': {'nctId': 'NCT02263560', 'acronym': 'SUPLOCO', 'briefTitle': 'Supraspinal Contributions to the Control of Human Locomotion: Clinical and Fundamental Aspects', 'organization': {'class': 'OTHER', 'fullName': 'University of Fribourg'}, 'officialTitle': 'Supraspinal Contributions to the Control of Human Locomotion: Clinical and Fundamental Aspects', 'orgStudyIdInfo': {'id': 'UFribourg'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Post-stroke patients', 'description': 'Patients who experienced stroke and who already recover gait abilities.', 'interventionNames': ['Behavioral: Kinematic measurements']}, {'label': 'Control population', 'description': "Participants matching the criterion (age and gender) of the patients' group.", 'interventionNames': ['Behavioral: Kinematic measurements']}], 'interventions': [{'name': 'Kinematic measurements', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Control population', 'Post-stroke patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1700', 'city': 'Fribourg', 'country': 'Switzerland', 'facility': 'University (UNIFR) and Hospital of Fribourg (HFR)', 'geoPoint': {'lat': 46.80237, 'lon': 7.15128}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Fribourg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dr Titus Bihl, Hopital Cantonal Fribourgeois', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer (PhD)', 'investigatorFullName': 'Halim HICHEUR', 'investigatorAffiliation': 'University of Fribourg'}}}}