Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-03-01 @ 8:56 PM
Study NCT ID:
NCT03707704
Status:
COMPLETED
Last Update Posted:
2020-01-13
First Post:
2018-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality Control of a Strengthening Protocol in Subjects With Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-09', 'studyFirstSubmitDate': '2018-10-11', 'studyFirstSubmitQcDate': '2018-10-11', 'lastUpdatePostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'One-repetition-maximum as parameter for the maximum force [kg]', 'timeFrame': 'Change from 0 weeks to 5 weeks and from 5 weeks to 10 weeks', 'description': 'Calculated one-repetition-maximum based on the Brzycki equation formula'}], 'secondaryOutcomes': [{'measure': 'Number of completed training sessions (training compliance)', 'timeFrame': 'Change from 0 weeks to 5 weeks and from 5 weeks to 10 weeks', 'description': 'Number of completed training sessions per participant'}, {'measure': 'Causes of study exclusion', 'timeFrame': 'From 0 weeks to 10 weeks', 'description': 'Systematic documentation of exclusion causes during the participation in the study'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Rehabilitation'], 'conditions': ['Spinal Cord Injury, Acute']}, 'descriptionModule': {'briefSummary': "The aim of the master's thesis is to evaluate the clinic-internal strengthening concept of the Swiss Paraplegic Centre (SPZ). The SPZ is a rehabilitation clinic for spinal cord injured people. The strengthening concept has been routinely used since 2015.\n\nBy default, the patients complete - depending on which training phase they are in - three to four strength training sessions per week. As part of the master's thesis, the development of maximum strength of patients with spinal cord injury (SCI) in primary rehabilitation will be studied. It is explicitly taken care of that the patients comply with the training requirements. Furthermore, factors which prevent a consistent buildup of strength - such as medical complications (pressure sores, pneumonia, urinary tract infections) - are systematically recorded.\n\nThe findings should provide information on the effect and qualitative transfer of the existing strength concept in everyday clinical practice. The strength training performed is accompanied by the master student and documented in a standardized manner."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with acute spinal cord injury during their initial rehabilitation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in initial rehabilitation\n* SCI Level C1-C5 (ASIA Score C-D)\n* SCI Lever C6-L5 (ASIA Score A-D)\n* Traumatic and non-traumatic SCI\n* Disease-related paraplegia, high-grade stenoses and central cord Syndromes\n* Age \\>= 18 years\n* The maximum force is tested on three predefined training devices, two devices for the upper and a device for the lower extremity. The participants will only be included in the study if they are capable of succeeding in at least both exercises for the upper extremity\n\nExclusion criteria:\n\n* Polyneuropathic diseases such as Critical Illness and Guillain Barré Syndrome\n* Degenerative diseases such as multiple sclerosis and amyotrophic lateral sclerosis etc.\n* Cognitive impairments\n* Compliance of less than 2/3 of the training sessions\n* ≥ 14 days without training\n* more than 6 weeks between assessments'}, 'identificationModule': {'nctId': 'NCT03707704', 'acronym': 'MKraft_Erstr', 'briefTitle': 'Quality Control of a Strengthening Protocol in Subjects With Spinal Cord Injury', 'organization': {'class': 'NETWORK', 'fullName': 'Swiss Paraplegic Research, Nottwil'}, 'officialTitle': 'Quality Control of an In-hospital Strengthening Protocol in Spinal Cord Injured Subjects During Initial Rehabilitation - a Prospective Observational Study', 'orgStudyIdInfo': {'id': '2018-16'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SCI patients in primary rehabilitation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6207', 'city': 'Nottwil', 'state': 'Canton of Lucerne', 'country': 'Switzerland', 'facility': 'Swiss Paraplegic Centre', 'geoPoint': {'lat': 47.13469, 'lon': 8.13774}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Paraplegic Research, Nottwil', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}