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

Septic Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05886166
• Other study ID #: HangangSHH-16
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Hangang Sacred Heart Hospital
• Contact: Baek Seongeun
• Phone: 82-2-2639-5900
• Email: tjddms1108[@]hallym.or.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2
• Est. completion date: December 31, 2023
• Est. primary completion date: December 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Infectious
• Gait Disorder, Sensorimotor
• Gait Disorders, Neurologic
• Septic Arthritis

Intervention

Other:
• robot assisted training
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hangang Sacred Heart Hospital

References & Publications (3)

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. — View 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 — View 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: 10.339 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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	8weeks
Secondary	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.	8 weeks