Clinical trial NCT05886166: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Septic Arthritis
Gait Disorder, Sensorimotor
Lead sponsor: Hangang Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Functional ambulatory category (FAC)
timeFrame: 8 weeks
Secondary outcomes:
measure: 6-min walking test (6 MWT) distance
timeFrame: 8 weeks
measure: visual analog scale (VAS)
timeFrame: 8 weeks
measure: Isometric muscle strength
timeFrame: 8weeks
measure: range of motion (ROM)
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.