Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-26 @ 1:39 AM
Study NCT ID:
NCT06176833
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2023-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Promoting Recovery Outcomes Through Precise Early Locomotor Interventions in Persons With Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Investigator and outcome assessor will have no knowledge of groups, cannot blind participants as they know when they will be receiving the additional training'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized into one of 4 intervention groups, based around if and when additional walking training is given following injury'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2023-12-11', 'studyFirstSubmitQcDate': '2023-12-11', 'lastUpdatePostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '10 Meter walk test', 'timeFrame': '1-5 days Following Intervention', 'description': 'Used to assess walking speed, time taken to walk 10 meters at fastest pace'}], 'secondaryOutcomes': [{'measure': '6 Minute Walk test', 'timeFrame': '1-5 days Following Intervention', 'description': 'Used to assess distance traveled during a 6 minute walking test at a self selected pace'}, {'measure': 'Walking Index for spinal cord injury', 'timeFrame': '1-5 days following intervention', 'description': 'Assessment to determine the physical assistance and assistive devices needed to walk 10 meters'}, {'measure': 'Daily step counts', 'timeFrame': '2 weeks following 3-, 6-, 9-, and 12- month assessments', 'description': 'Step counts from a waist worn activity tracker'}, {'measure': 'Gait Deviation idex', 'timeFrame': 'Baseline, 3-, 6-, 9-, and 12- month assessments', 'description': 'A measure of gait quality by quantifying joint angles during a gait cycle. This data is recorded via a marker-less motion capture system'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Cord Injuries']}, 'referencesModule': {'references': [{'pmid': '39702102', 'type': 'DERIVED', 'citation': "Henry M, Coxe RC, Barry A, O'Donnell A, Kessler A, Shan G, Swank C, Rymer WZ, Sandhu MS. A research protocol to study the critical time window for rehabilitation after incomplete spinal cord injury: early vs. late locomotor training. BMC Neurol. 2024 Dec 19;24(1):482. doi: 10.1186/s12883-024-03980-x."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate if a specific type of additional walking therapy, called body weight supported treadmill training (BWSTT) affects walking ability following a traumatic spinal cord injury. Specifically, the study will look at whether starting BWSTT, which uses a body harness to support body weight while walking on a treadmill at different times within the first 6 months after the injury, makes a difference in how effective this therapy may be, While we know that the brain re-learns patterns following an injury, there has not been a lot of prior research evaluating how starting this type of walking therapy at specific times within the first 6 months after injury may impact any effectiveness of the additional therapy.\n\nThe study will randomize participants into four groups: those who start this therapy within 60 days, within 3 months, within 6 months or who do not receive this additional research therapy. Randomization means that which group you will be in as part of this study is determined by chance, like the flip of a coin. The additional walking therapy for this research study, if you are randomized for one of the three groups who receives the additional therapy, will be given on top of (meaning in addition to) any standard of care therapies that you may be receiving at that time point after your injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of Acute and Traumatic SCI with AIS classification of B, C, or D between the neurological levels of C5 and T12\n* Between the ages of 16-74\n* Weight bearing as tolerated in bilateral lower extremities\n* Able to tolerate a harness\n* Ability to provide informed consent. For minors, consent of parents or primary caregivers/guardians and assent of the minor\n* Able to provide informed consent within 60 days of injury onset\n* Able to participate in all study related activities, including 1-year follow up\n\nExclusion Criteria:\n\n* Orthopedic injuries, fractures, surgeries, or other conditions affecting locomotor function or weight bearing\n* A weight over 250lbs and if so a BMI greater than 30, or deemed clinically inappropriate due to body habitus\n* Moderate to sever traumatic brain injury of other neurological conditions at a severity which impairs cognition\n* Presence of uncontrolled orthostatic hypotension that limits active participation in intense physical rehabilitation program.\n* Other medical complications such as severe heart failure or large/deep pelvic or lower abdominal wounds that may limit the ability to safely don and doff a harness for ambulation\n* Pregnancy, as confirmed by blood draw'}, 'identificationModule': {'nctId': 'NCT06176833', 'acronym': 'PROPEL-SCI', 'briefTitle': 'Promoting Recovery Outcomes Through Precise Early Locomotor Interventions in Persons With Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'Shirley Ryan AbilityLab'}, 'officialTitle': 'Critical Time Window for Rehabilitation After Incomplete Spinal Cord Injury: Early vs Late Locomotor Training', 'orgStudyIdInfo': {'id': 'STU00219541'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Early Intervention', 'description': 'Additional training will begin no more than 60 days following spinal cord injury', 'interventionNames': ['Procedure: Body Weight Supported Treadmill Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sub-acute Intervention', 'description': 'Additional training will occur 3 months following spinal cord injury', 'interventionNames': ['Procedure: Body Weight Supported Treadmill Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chronic Intervention', 'description': 'Additional training will occur 6-12 months following SCI', 'interventionNames': ['Procedure: Body Weight Supported Treadmill Training']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'This group only receives standard of care treatment but is assessed at the same time points as the other groups'}], 'interventions': [{'name': 'Body Weight Supported Treadmill Training', 'type': 'PROCEDURE', 'otherNames': ['BWSTT'], 'description': 'For these training sessions, participants will undergo walking training sessions that consist of wearing a harness for either body weight support or as a safety precaution while walking on a treadmill.', 'armGroupLabels': ['Chronic Intervention', 'Early Intervention', 'Sub-acute Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Milap Sandhu, Phd', 'role': 'CONTACT', 'email': 'msandhu@sralab.org', 'phone': '312-238-6529'}, {'name': 'Alexander Barry, MS, CCRC', 'role': 'CONTACT', 'email': 'abarry@sralab.org', 'phone': '312-238-1435'}, {'name': 'Milap Sandhu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'William Z Rymer, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Shirley Ryan AbilityLab', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '76132', 'city': 'Fort Worth', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Faith Meza, MPH', 'role': 'CONTACT', 'email': 'faith.meza@bswhealth.org', 'phone': '214-820-9409'}, {'name': 'Chad Swank, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baylor Scott and White Institute for Rehabilitation', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], 'centralContacts': [{'name': 'Alexander Barry, MS, CCRC', 'role': 'CONTACT', 'email': 'abarry@sralab.org', 'phone': '3122381435'}], 'overallOfficials': [{'name': 'Milap Sandhu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shirley Ryan AbilityLab'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We are not currently planning to make individual participant data available to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milap Sandhu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baylor Scott and White Health', 'class': 'OTHER'}, {'name': 'University of Florida', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Milap Sandhu', 'investigatorAffiliation': 'Shirley Ryan AbilityLab'}}}}