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

Sponsor
Hangang Sacred Heart Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05886166
Collaborator
(none)
2
1
6.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: robot assisted training
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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.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)
Primary Purpose:
Treatment
Official Title:
Clinical Utility of Exoskeleton Robot Training in Patients With Septic Arthritis After a Thermal Injury: A Case Report
Anticipated Study Start Date :
Jun 15, 2023
Anticipated Primary Completion Date :
Dec 25, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Functional ambulatory category (FAC) [8 weeks]

    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

  1. 6-min walking test (6 MWT) distance [8 weeks]

    6MWT measures the maximum distance a participant can walk in 6 min on a 20 m flat surface.

  2. visual analog scale (VAS) [8 weeks]

    The visual analog scale (VAS) is used to assess subjective pain, with 0 representing no pain and 10 representing unbearable pain.

  3. Isometric muscle strength [8weeks]

    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

  4. range of motion (ROM) [8 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hangang Sacred Heart Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
So Young Joo, Hangang Sacred Heart Hospital IRB, Hangang Sacred Heart Hospital
ClinicalTrials.gov Identifier:
NCT05886166
Other Study ID Numbers:
  • HangangSHH-16
First Posted:
Jun 2, 2023
Last Update Posted:
Jun 2, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 2, 2023