Clinical Utility of Robot-Assisted Gait Training in Patients With Spinal Cord Injury Caused by Electrical Burns: A Case Report

NCT ID: NCT05883917

Last Updated: 2023-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-15

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Robot-assisted gait training has been effective in several diseases. Nevertheless, evidence supporting the efficacy of such training in burn patients remains insufficient. This report aimed to evaluate the effect of robot-assisted gait training in burn patients with spinal cord injuries caused by electrical trauma.

We will report a case of two patients who underwent 30 min of robot-assisted gait training using SUBAR® (Cretem, Korea) with 30 min of conventional physiotherapy, 5 days a week for 12 weeks.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Robot-assisted gait training has been effective in several diseases. Nevertheless, evidence supporting the efficacy of such training in burn patients remains insufficient. This report aimed to evaluate the effect of robot-assisted gait training in burn patients with spinal cord injuries caused by electrical trauma.

Gait training using SUBAR® (Cretem, Korea) proceeded by adjusting parameters (gait speed, step length, and degree of knee flexion) according to the patient's leg length and gait function. The parameters were set to the maximum levels tolerated by the patient. The patients underwent 30 min of robot-assisted training using SUBAR® with 30 min of conventional physiotherapy, 5 days a week for 12 weeks.

All measurements were assessed before training (0 week) and after training (12 weeks). The American Spinal Injury Association (ASIA) lower extremity motor subscale score (LEMS; range 0-50) was used to evaluate motor function. LEMS is the sum of bilateral lower extremity key muscle power, ranging from total paralysis (0) to normal active movement with a full range of motion against gravity and maximum resistance (5), with a total possible score of 50. The passive range of motions (ROMs) of different joints (hip, knee, and ankle) were measured using a goniometer. The ambulatory motor index (AMI; range 0-30), which predicts ambulatory capability, was measured by evaluating muscles of hip flexion, hip abduction, hip extension, knee extension, and knee flexion on both sides. Functional Ambulation Categories (FAC) scores and 6-min walking test (6MWT) distances were measured to evaluate functional recovery. FAC was evaluated based on a 6-point scale, from 0 (the patient cannot walk or can only walk with the assistance of two people) to 5 (the patient can walk independently). 6MWT followed the standardised guidelines, and the walking course was 20 m. The patients were instructed to walk as far as possible in 6 min .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gait Disorder, Sensorimotor Burns Spinal Cord Injuries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Gait training using SUBAR® (Cretem, Korea) proceeded by adjusting parameters (gait speed, step length, and degree of knee flexion) according to the patient's leg length and gait function. The parameters were set to the maximum levels tolerated by the patient. The patients underwent 30 min of robot-assisted training using SUBAR® with 30 min of conventional physiotherapy, 5 days a week for 12 weeks.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

robot assisted gait training

Gait training using SUBAR® (Cretem, Korea) proceeded by adjusting parameters (gait speed, step length, and degree of knee flexion) according to the patient's leg length and gait function. The parameters were set to the maximum levels tolerated by the patient. The patients underwent 30 min of robot-assisted training using SUBAR® with 30 min of conventional physiotherapy, 5 days a week for 12 weeks.

Group Type EXPERIMENTAL

robot assisted gait training

Intervention Type PROCEDURE

Gait training using SUBAR® (Cretem, Korea) proceeded by adjusting parameters (gait speed, step length, and degree of knee flexion) according to the patient's leg length and gait function. The parameters were set to the maximum levels tolerated by the patient. The patients underwent 30 min of robot-assisted training using SUBAR® with 30 min of conventional physiotherapy, 5 days a week for 12 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

robot assisted gait training

Gait training using SUBAR® (Cretem, Korea) proceeded by adjusting parameters (gait speed, step length, and degree of knee flexion) according to the patient's leg length and gait function. The parameters were set to the maximum levels tolerated by the patient. The patients underwent 30 min of robot-assisted training using SUBAR® with 30 min of conventional physiotherapy, 5 days a week for 12 weeks.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* electrical burn
* spinal cord injury
* aged \> 18 years
* aged \<75 years
* ≤ 1 functional ambulation category (FAC) score of ≤3

Exclusion Criteria

* had fourth-degree burns (involving muscles, tendons, and bone injuries)
* had musculoskeletal diseases (fracture, amputation, rheumatoid arthritis, and degenerative joint diseases) involving the burned lower extremity.
* cognitive disorders
* intellectual impairment before burn injury
* serious cardiac dysfunction
* skin disorders that could be worsened by RAGT
* severe pain who were unable to undergo rehabilitation programs
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hangang Sacred Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

So Young Joo

Hangang Sacred Heart Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Baek Seongeun

Role: CONTACT

82-2-2639-5900

References

Explore related publications, articles, or registry entries linked to this study.

Ohn SH, Kim DY, Shin JC, Kim SM, Yoo WK, Lee SK, Park CH, Jung KI, Jang KU, Seo CH, Koh SH, Jung B. Analysis of high-voltage electrical spinal cord injury using diffusion tensor imaging. J Neurol. 2013 Nov;260(11):2876-83. doi: 10.1007/s00415-013-7081-1. Epub 2013 Sep 4.

Reference Type RESULT
PMID: 24002417 (View on PubMed)

Cheung EYY, Ng TKW, Yu KKK, Kwan RLC, Cheing GLY. Robot-Assisted Training for People With Spinal Cord Injury: A Meta-Analysis. Arch Phys Med Rehabil. 2017 Nov;98(11):2320-2331.e12. doi: 10.1016/j.apmr.2017.05.015. Epub 2017 Jun 20.

Reference Type RESULT
PMID: 28645768 (View on PubMed)

Lee SY, Seo CH, Ch YS, Kim Y, Yoon Y, Joo SY. Exoskeleton Robot Training in Two Patients with an Electrical Burn and Septic Arthritis: A Case Report. J Burn Care Res. 2025 Aug 12;46(3):646-651. doi: 10.1093/jbcr/irae205.

Reference Type DERIVED
PMID: 39851068 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HangangSHH-15

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.