Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-26 @ 11:53 AM
Study NCT ID:
NCT05225792
Status:
RECRUITING
Last Update Posted:
2025-03-17
First Post:
2021-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rapid Rehabilitation to Treat Lower Extremity Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2021-12-08', 'studyFirstSubmitQcDate': '2022-02-02', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prosthesis Evaluation Questionnaire-Addendum (PEQ-A)', 'timeFrame': '0, 6 months', 'description': 'Fall incidence change between baseline and 6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lower Limb Trauma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out if an advance balance perturbation training program can enhance the rehabilitation process by increasing weight-bearing strategies on the prosthetic or injured limb, and, help reduce stumbles and falls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Research participants will be eligible active duty service members and retired veterans.\n* Having lower limb trauma (transtibial and transfemoral amputations, bilateral amputations, and limb salvage).\n* Are enrolled in conventional rehabilitation at the participating military treatment centers.\n* Subjects with dysvascular disease will be excluded because compromised lower limb somatosensation and circulation are independently linked with poor postural stability and a history of frequent falls.\n* For subjects with amputations, the individual must be a community ambulator (i.e., K-Level 3 or 4).\n* For subjects with limb salvage, they will need to have an IDEO and be entered into the Return-to-Run training program.\n\nExclusion Criteria:\n\n\\- Subjects must not have excessive pain or other neuromuscular problems that preclude them from performing the test protocol.'}, 'identificationModule': {'nctId': 'NCT05225792', 'briefTitle': 'Rapid Rehabilitation to Treat Lower Extremity Trauma', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Improved Training Method for Advanced Rehabilitation of Warfighters With Lower Extremity Trauma', 'orgStudyIdInfo': {'id': '21-010009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Injured Service Members', 'interventionNames': ['Behavioral: Promis Physical Function Questionnaire', 'Behavioral: L Test', 'Behavioral: Narrowing Beam Walking Test', 'Behavioral: PEQ-A']}], 'interventions': [{'name': 'Promis Physical Function Questionnaire', 'type': 'BEHAVIORAL', 'description': 'Patient reported physical function outcomes', 'armGroupLabels': ['Injured Service Members']}, {'name': 'L Test', 'type': 'BEHAVIORAL', 'description': 'Performance based measure assessing general physical function and balance ability.', 'armGroupLabels': ['Injured Service Members']}, {'name': 'Narrowing Beam Walking Test', 'type': 'BEHAVIORAL', 'description': 'Subjects attempt to walk along 4 progressively narrower beam segments with their arms crossed over their chest.', 'armGroupLabels': ['Injured Service Members']}, {'name': 'PEQ-A', 'type': 'BEHAVIORAL', 'otherNames': ['Prosthesis Evaluation Questionnaire - Addendum'], 'description': 'Survey on confidence, stumbles and falls.', 'armGroupLabels': ['Injured Service Members']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christine Deml', 'role': 'CONTACT', 'email': 'deml.christine@mayo.edu', 'phone': '507-266-0984'}], 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Christine Huyber, CCRP', 'role': 'CONTACT', 'email': 'Huyber.Christine@mayo.edu', 'phone': '(507) 266-0984'}], 'overallOfficials': [{'name': 'Kenton Kaufman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kenton R. Kaufman, PhD, PE', 'investigatorAffiliation': 'Mayo Clinic'}}}}