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Clinical Utility of Exoskeleton Robot Training in Patients With Septic Arthritis After a Thermal Injury: A Case Report

Primary Purpose

Septic Arthritis, Gait Disorder, Sensorimotor

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
robot assisted training
Sponsored by
Hangang Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: diagnosed with septic arthritis aged >18 years, < 75 years when weight bearing is not possible during intravenous antibiotic treatment in this study. Exclusion Criteria: had musculoskeletal diseases (fracture, amputation, rheumatoid arthritis, and degenerative joint diseases) cognitive disorders intellectual impairment before burn injury serious cardiac dysfunction skin disorders that could be worsened by robot training

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    robot assisted training

    Arm 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.

    Outcomes

    Primary Outcome Measures

    Functional ambulatory category (FAC)
    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.

    Secondary Outcome Measures

    6-min walking test (6 MWT) distance
    6MWT measures the maximum distance a participant can walk in 6 min on a 20 m flat surface.
    visual analog scale (VAS)
    The visual analog scale (VAS) is used to assess subjective pain, with 0 representing no pain and 10 representing unbearable pain.
    Isometric muscle strength
    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
    range of motion (ROM)
    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.

    Full Information

    First Posted
    May 23, 2023
    Last Updated
    May 23, 2023
    Sponsor
    Hangang Sacred Heart Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05886166
    Brief Title
    Clinical Utility of Exoskeleton Robot Training in Patients With Septic Arthritis After a Thermal Injury: A Case Report
    Official Title
    Clinical Utility of Exoskeleton Robot Training in Patients With Septic Arthritis After a Thermal Injury: A Case Report
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 15, 2023 (Anticipated)
    Primary Completion Date
    December 25, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hangang Sacred Heart Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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. The patients underwent 30 min of robot training using Rebless® with 30 min conventional therapy, 5 days a week for 8 weeks. This study aims to confirm the clinical effect after 8 weeks of robotic treatment for patients diagnosed with septic arthritis.
    Detailed Description
    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. Patients 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. The patients underwent 30 min of robot training using Rebless® with 30 min conventional therapy, 5 days a week for 8 weeks. This study aims to confirm the clinical effect after 8 weeks of robotic treatment for patients diagnosed with septic arthritis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Septic Arthritis, Gait Disorder, Sensorimotor

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model 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.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    2 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    robot assisted training
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Other
    Intervention Name(s)
    robot assisted training
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Functional ambulatory category (FAC)
    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.
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    6-min walking test (6 MWT) distance
    Description
    6MWT measures the maximum distance a participant can walk in 6 min on a 20 m flat surface.
    Time Frame
    8 weeks
    Title
    visual analog scale (VAS)
    Description
    The visual analog scale (VAS) is used to assess subjective pain, with 0 representing no pain and 10 representing unbearable pain.
    Time Frame
    8 weeks
    Title
    Isometric muscle strength
    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
    Time Frame
    8weeks
    Title
    range of motion (ROM)
    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.
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: diagnosed with septic arthritis aged >18 years, < 75 years when weight bearing is not possible during intravenous antibiotic treatment in this study. Exclusion Criteria: had musculoskeletal diseases (fracture, amputation, rheumatoid arthritis, and degenerative joint diseases) cognitive disorders intellectual impairment before burn injury serious cardiac dysfunction skin disorders that could be worsened by robot training
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Baek Seongeun
    Phone
    82-2-2639-5900
    Email
    tjddms1108@hallym.or.kr

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32758534
    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.
    Results Reference
    result
    PubMed Identifier
    10812274
    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.
    Results Reference
    result
    PubMed Identifier
    36766901
    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.
    Results Reference
    result

    Learn more about this trial

    Clinical Utility of Exoskeleton Robot Training in Patients With Septic Arthritis After a Thermal Injury: A Case Report

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