Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-28 @ 5:04 PM
Study NCT ID:
NCT05886166
Status:
UNKNOWN
Last Update Posted:
2023-06-02
First Post:
2023-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Utility of Exoskeleton Robot Training in Patients With Septic Arthritis After a Thermal Injury: A Case Report
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001170', 'term': 'Arthritis, Infectious'}, {'id': 'D020233', 'term': 'Gait Disorders, Neurologic'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Rebless® (H-ROBOTICS, KOREA) is a knee or ankle robot for range of motion (ROM) and strength training that can operate in passive or active mode in knee or ankle flexion and extension. The patients underwent 30 min of robot training using Rebless® with 30 min conventional therapy, 5 days a week for 8 weeks.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-06-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-23', 'studyFirstSubmitDate': '2023-05-23', 'studyFirstSubmitQcDate': '2023-05-23', 'lastUpdatePostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional ambulatory category (FAC)', 'timeFrame': '8 weeks', 'description': '6-point scale: 0, the patient could not walk or could only walk with the assistance of two people and 5, the patient can walk independently.'}], 'secondaryOutcomes': [{'measure': '6-min walking test (6 MWT) distance', 'timeFrame': '8 weeks', 'description': '6MWT measures the maximum distance a participant can walk in 6 min on a 20 m flat surface.'}, {'measure': 'visual analog scale (VAS)', 'timeFrame': '8 weeks', 'description': 'The visual analog scale (VAS) is used to assess subjective pain, with 0 representing no pain and 10 representing unbearable pain.'}, {'measure': 'Isometric muscle strength', 'timeFrame': '8weeks', 'description': 'Isometric muscle strength (hip, knee, and ankle) was measured using a microFET IITM (Hoggan Health Industries, Draper, UT, USA). Each trial lasted for 3-5 s, with a 30-s rest period between trials'}, {'measure': 'range of motion (ROM)', 'timeFrame': '8 weeks', 'description': 'The highest values obtained from the two valid measurements were recorded. The active ROMs of different joints (hip, knee, and ankle) were measured using a goniometer following a standardized technique.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Septic Arthritis', 'Gait Disorder, Sensorimotor']}, 'referencesModule': {'references': [{'pmid': '32758534', 'type': 'RESULT', 'citation': 'Couderc M, Bart G, Coiffier G, Godot S, Seror R, Ziza JM, Coquerelle P, Darrieutort-Laffite C, Lormeau C, Salliot C, Veillard E, Bernard L, Baldeyrou M, Bauer T, Hyem B, Touitou R, Fouquet B, Mulleman D, Flipo RM, Guggenbuhl P; French Rheumatology Society Bone, Joint Infection Working Group. 2020 French recommendations on the management of septic arthritis in an adult native joint. Joint Bone Spine. 2020 Dec;87(6):538-547. doi: 10.1016/j.jbspin.2020.07.012. Epub 2020 Aug 3.'}, {'pmid': '10812274', 'type': 'RESULT', 'citation': 'Barret JP, Desai MH, Herndon DN. Osteomyelitis in burn patients requiring skeletal fixation. Burns. 2000 Aug;26(5):487-9. doi: 10.1016/s0305-4179(99)00182-5.'}, {'pmid': '36766901', 'type': 'RESULT', 'citation': 'Ju F, Wang Y, Xie B, Mi Y, Zhao M, Cao J. The Use of Sports Rehabilitation Robotics to Assist in the Recovery of Physical Abilities in Elderly Patients with Degenerative Diseases: A Literature Review. Healthcare (Basel). 2023 Jan 21;11(3):326. doi: 10.3390/healthcare11030326.'}]}, 'descriptionModule': {'briefSummary': 'Bone and/or joint infections, such as septic arthritis (SA), are rare, but delayed diagnosis or improper treatment can result in irreversible joint destruction. Therefore, early diagnosis and effective treatment are necessary to prevent severe outcomes. Clear protocols for SA rehabilitation are unavailable, and physiotherapy studies are few. Robot training in patients with musculoskeletal diseases, including burns, can reduce pain and improve lower extremity function. Studies on robot training have been conducted in patients with burn injuries. Rebless® (H-ROBOTICS, KOREA) is a knee or ankle robot for range of motion (ROM) and strength training that can operate in passive or active mode in knee or ankle flexion and extension.\n\nThe patients underwent 30 min of robot training using Rebless® with 30 min conventional therapy, 5 days a week for 8 weeks.\n\nThis study aims to confirm the clinical effect after 8 weeks of robotic treatment for patients diagnosed with septic arthritis.', 'detailedDescription': 'Bone and/or joint infections, such as septic arthritis (SA), are rare, but delayed diagnosis or improper treatment can result in irreversible joint destruction. Therefore, early diagnosis and effective treatment are necessary to prevent severe outcomes. Clear protocols for SA rehabilitation are unavailable, and physiotherapy studies are few. Robot training in patients with musculoskeletal diseases, including burns, can reduce pain and improve lower extremity function. Studies on robot training have been conducted in patients with burn injuries. Rebless® (H-ROBOTICS, KOREA) is a knee or ankle robot for range of motion (ROM) and strength training that can operate in passive or active mode in knee or ankle flexion and extension.\n\nPatients who underwent split thickness skin graft (STSG) at Hangang Sacred Heart Hospital, diagnosed with septic arthritis, aged \\>18 years, when weight bearing is not possible during intravenous antibiotic treatment in this study. This study excluded patients who had musculoskeletal diseases (fracture, amputation, rheumatoid arthritis, and degenerative joint diseases) involving the burned lower extremity. Patients with cognitive disorders, intellectual impairment before burn injury, serious cardiac dysfunction, problems with body weight ≥100 kg due to the belt length for fixing the thigh and calf, severe fixed contracture, skin disorders that could be worsened by RAGT, and severe pain who were unable to undergo rehabilitation programs were excluded.\n\nThe patients underwent 30 min of robot training using Rebless® with 30 min conventional therapy, 5 days a week for 8 weeks.\n\nThis study aims to confirm the clinical effect after 8 weeks of robotic treatment for patients diagnosed with septic arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with septic arthritis\n* aged \\>18 years, \\< 75 years\n* when weight bearing is not possible during intravenous antibiotic treatment in this study.\n\nExclusion Criteria:\n\n* had musculoskeletal diseases (fracture, amputation, rheumatoid arthritis, and degenerative joint diseases)\n* cognitive disorders\n* intellectual impairment before burn injury\n* serious cardiac dysfunction\n* skin disorders that could be worsened by robot training'}, 'identificationModule': {'nctId': 'NCT05886166', 'briefTitle': 'Clinical Utility of Exoskeleton Robot Training in Patients With Septic Arthritis After a Thermal Injury: A Case Report', 'organization': {'class': 'OTHER', 'fullName': 'Hangang Sacred Heart Hospital'}, 'officialTitle': 'Clinical Utility of Exoskeleton Robot Training in Patients With Septic Arthritis After a Thermal Injury: A Case Report', 'orgStudyIdInfo': {'id': 'HangangSHH-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'robot assisted training', 'description': 'Rebless® (H-ROBOTICS, KOREA) is a knee or ankle robot for range of motion (ROM) and strength training that can operate in passive or active mode in knee or ankle flexion and extension. The patients underwent 30 min of robot training using Rebless® with 30 min conventional therapy, 5 days a week for 8 weeks.', 'interventionNames': ['Other: robot assisted training']}], 'interventions': [{'name': 'robot assisted training', 'type': 'OTHER', 'description': 'Rebless® (H-ROBOTICS, KOREA) is a knee or ankle robot for range of motion (ROM) and strength training that can operate in passive or active mode in knee or ankle flexion and extension. The patients underwent 30 min of robot training using Rebless® with 30 min conventional therapy, 5 days a week for 8 weeks.', 'armGroupLabels': ['robot assisted training']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Baek Seongeun', 'role': 'CONTACT', 'email': 'tjddms1108@hallym.or.kr', 'phone': '82-2-2639-5900'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hangang Sacred Heart Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hangang Sacred Heart Hospital IRB', 'investigatorFullName': 'So Young Joo', 'investigatorAffiliation': 'Hangang Sacred Heart Hospital'}}}}