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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05883917
• Other study ID #: HangangSHH-15
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Hangang Sacred Heart Hospital
• Contact: Baek Seongeun
• Phone: 82-2-2639-5900
• Email: tjddms1108[@]hallym.or.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2
• Est. completion date: December 31, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Gait Disorder, Sensorimotor
• Gait Disorders, Neurologic
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hangang Sacred Heart Hospital

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Spinal Injury Association		12 weeks
Secondary	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	12 weeks
Secondary	passive range of motions	The passive range of motions (ROMs) of different joints (hip, knee, and ankle) were measured using a goniometer	12 weeks
Secondary	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	12 weeks