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

May 22, 2023 updated by: So Young Joo, Hangang Sacred Heart Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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 .

Study Type

Interventional

Enrollment (Estimated)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
American Spinal Injury Association
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lower extremity motor subscale score (LEMS; range 0-50)
Time Frame: 12 weeks
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
12 weeks
passive range of motions
Time Frame: 12 weeks
The passive range of motions (ROMs) of different joints (hip, knee, and ankle) were measured using a goniometer
12 weeks
The ambulatory motor index (AMI; range 0-30)
Time Frame: 12 weeks
predicts ambulatory capability, was measured by evaluating muscles of hip flexion, hip abduction, hip extension, knee extension, and knee flexion on both sides
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hangang Sacred Heart Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2023

Primary Completion (Estimated)

December 15, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

May 22, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

June 1, 2023

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HangangSHH-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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