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Not yet recruitingNCT05883917Updated Jun 1, 2023

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

An interventional study of robot assisted gait training in Gait Disorder, Sensorimotor, Burns and Spinal Cord Injuries, sponsored by Hangang Sacred Heart Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-06-01.

Sponsored by Hangang Sacred Heart Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the 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 .

02

Conditions studied

  • Gait Disorder, Sensorimotor
  • Burns
  • Spinal Cord Injuries
03

In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's planned enrollment of 2 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Hangang Sacred Heart Hospital is the lead sponsor of 24 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (estimated)

Study arms

  • 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

Interventions

  • Procedurerobot 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.

06

What researchers measure

Primary outcomes

  1. American Spinal Injury Association

    Time frame: 12 weeks

Secondary outcomes

  1. lower extremity motor subscale score (LEMS; range 0-50)

    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

    Time frame: 12 weeks

  2. passive range of motions

    The passive range of motions (ROMs) of different joints (hip, knee, and ankle) were measured using a goniometer

    Time frame: 12 weeks

  3. The ambulatory motor index (AMI; range 0-30)

    predicts ambulatory capability, was measured by evaluating muscles of hip flexion, hip abduction, hip extension, knee extension, and knee flexion on both sides

    Time frame: 12 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 24002417 ↗
  • 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. PubMed 28645768 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05883917
Lead sponsor
Hangang Sacred Heart Hospital
Responsible party
So Young Joo (Hangang Sacred Heart Hospital, Hangang Sacred Heart Hospital) — Principal investigator
First posted
Jun 1, 2023
Start date
Jun 15, 2023 (estimated)
Primary completion
Dec 15, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Jun 1, 2023

Study contacts

Baek Seongeun
Contact
tjddms1108@hallym.or.kr
82-2-2639-5900

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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