NCT05883917

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

May 22, 2023

Last Update Submit

May 22, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • American Spinal Injury Association

    12 weeks

Secondary Outcomes (3)

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

    12 weeks

  • passive range of motions

    12 weeks

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

    12 weeks

Study Arms (1)

robot assisted gait training

EXPERIMENTAL

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

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.

robot assisted gait training

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Gait Disorders, NeurologicBurnsSpinal Cord Injuries

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and InjuriesSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous System

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

May 22, 2023

First Posted

June 1, 2023

Study Start

June 15, 2023

Primary Completion

December 15, 2023

Study Completion

December 31, 2023

Last Updated

June 1, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share