Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT03405558
Status:
COMPLETED
Last Update Posted:
2023-03-13
First Post:
2018-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Performance Developement of Patients With Paraplegia During First Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-10', 'studyFirstSubmitDate': '2018-01-08', 'studyFirstSubmitQcDate': '2018-01-19', 'lastUpdatePostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak power', 'timeFrame': '10min', 'description': 'Maximal performance reached during incremental exercise on an arm-crank ergometer'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Physical Activity']}, 'descriptionModule': {'briefSummary': 'A high physical fitness is crucial for a good quality of life in persons suffering from a spinal cord injury. The aim of the present observational study is to investigate the influence of an individually tailored 8-week endurance training program on endurance performance of patients with a paraplegia during their first rehabilitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with a paraplegia during the first rehabilitation', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* male or female, paraplegia (AIS A-C, lesion Level Th1-Th12)\n* Age 18-65 years\n* Manual wheelchair user\n* Patient during first rehabilitation\n\nExclusion Criteria:\n\n* BMI ≥ 30\n* unable to use an arm-crank Ergometer due to e.g. spasticity\n* physical impairment, which makes it impossible to perform an arm-crank ergometry\n* Progressive disease (g.g. tumor, MS)\n* Ventilator dependent\n* existing cardiopulmonary disease\n* Unstable medical situation'}, 'identificationModule': {'nctId': 'NCT03405558', 'briefTitle': 'Performance Developement of Patients With Paraplegia During First Rehabilitation', 'organization': {'class': 'NETWORK', 'fullName': 'Swiss Paraplegic Research, Nottwil'}, 'officialTitle': 'Effects of an Individually Tailored Endurance Training on the Performance Developement of Patients With Paraplegia During First Rehabilitation: an Observational Study', 'orgStudyIdInfo': {'id': '2017-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'As this is an observational study, we will only supervise testing and training sessions which were performed anyway during first rehabilitation as daily therapeutic routine'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6207', 'city': 'Nottwil', 'state': 'Canton of Lucerne', 'country': 'Switzerland', 'facility': 'Swiss Paraplegic Centre', 'geoPoint': {'lat': 47.13469, 'lon': 8.13774}}], 'overallOfficials': [{'name': 'Claudio Perret', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swiss Paraplegic Research, Nottwil'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Paraplegic Research, Nottwil', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}