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

NCT05886166 | Unknown DMC

• 1 other identifier: HangangSHH-16
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Septic Arthritis; Gait Disorder, Sensorimotor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 6-min walking test (6 MWT) distance

  8 weeks

• visual analog scale (VAS)

  8 weeks

• Isometric muscle strength

  8weeks

• range of motion (ROM)

  8 weeks

Study Arms (1)

robot assisted training

EXPERIMENTAL

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.

Other: robot assisted training

Interventions

robot assisted training OTHER

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.

robot assisted training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with septic arthritis
• aged \>18 years, \< 75 years
• when weight bearing is not possible during intravenous antibiotic treatment in this study.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hangang Sacred Heart Hospital: lead

Related Publications (3)

• 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: 32758534 RESULT

• 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: 10812274 RESULT

• 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.

  PMID: 36766901 RESULT

MeSH Terms

Conditions

Arthritis, Infectious; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Infections; Arthritis; Joint Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Baek Seongeun

CONTACT

82-2-2639-5900; tjddms1108@hallym.or.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hangang Sacred Heart Hospital IRB

Model Details: 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.

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 2, 2023
• Study Start: June 15, 2023
• Primary Completion: December 25, 2023
• Study Completion: December 31, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share