The Effects of Robot-assisted Gait Training(RAGT) On Patients With Burn

Burns Clinical Trial

Official title:

The Effects of Gait Performance and Brain Activity After Robot-assisted Gait Training(RAGT) On Patients With Lower Extremity Thermal Injury : a Prospective, Randomized, Single-blinded Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03992547
• Other study ID #: HangangSHH-4
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2019
• Est. completion date: October 31, 2020

Study information

• Verified date: June 2019
• Source: Hangang Sacred Heart Hospital
• Contact: SO YOUNG JOO, M.D.
• Phone: +82-2-2639-5735
• Email: anyany98[@]hallym.or.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to elucidate the efficacy and investigate the mechanism of motor recovery after RAGT on patients with lower extremity burn. To investigate RAGT effects, we compare the results of RGAT group to the results of matched conventional(CON) rehabilitation group.

Description:

Gait enables individuals to move forward and is considered a natural skill. However, gait disturbances are very common in patients with burn injury. Major causes of functional impairment are pain and joint contractures. Contractures at the lower extremities such as the hip, knee, and ankle significantly limit gait. Recent studies focused on the application of robot-assisted gait training (RAGT).

This single-blinded, randomized, controlled trial involved 40 patients with lower extremity burns. Patients were randomized into a RAGT or a CON group.

SUBAR® (CRETEM, Korea) is a wearable robot with a footplate that assists patients to perform voluntary muscle movements. RAGT enables training of automatically programmed normal gait pattern. Patients underwent 30 min of RAGT using SUBAR® and conventional exercise rehabilitation each for 30 min once a day for 5 days a week for 12 weeks. The CON group focused on gait training such as passive ROM exercise, weight bearing training, manual lymphatic drainage, and hypertrophic scar care for 60 min once a day for 5 days a week for 12 weeks.

A wearable functional near-infrared spectroscopy (fNIRS) device has been developed for studying cortical hemodynamics. Changes in cortical activity has not previously been documented in patients with burn injury. Cortical activity was measured by evaluating relative changes in oxyhemoglobin level. The NIRST Analysis Tool v2.1 was utilized to analyze fNIRS data in a MATLAB environment. Functional scores of functional ambulation category (FAC), 6-minute walking test (6MWT) distances, and numeric rating scale (NRS) scores of pain before and after 12 weeks RAGT were measured. Numeric rating scale (NRS) was used to rate the degree of subjective pain during gait movement: 0 points were assigned when no pain was noted, and unbearable pain was assigned 10 points. To evaluate functional recovery, FAC scores and 6-minute walking test (6MWT) distances were measured. FAC was evaluated based on six scales. Scale 0 means that the patient cannot walk or can only walk with assistance of two people. Scale 5 means that the patient can walk independently. We measured walking-related cortical activity using an fNIRS device before and after 12 weeks RAGT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 31, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• the parients with lower extremity burn

• =1 functional ambulation category (FAC) score = 3

Exclusion Criteria:

• cognitive disorders

• intellectual impairment before burn injury

• serious cardiac dysfunction

• problems with weight bearing due to unstable fractures

• body weight =100 kg

• severe fixed contracture

• skin disorders that could be worsened by robot assisted gait training

Related Conditions & MeSH terms

• Burns

Intervention

Other:
• Robot-assisted Gait Training
SUBAR® (CRETEM, Korea) is a wearable robot with a footplate that assists patients to perform voluntary muscle movements. RAGT enables training of automatically programmed normal gait pattern.

Locations

Country	Name	City	State
Korea, Republic of	Hangang Sacred Heart Hospital	Seoul	Yeongdeungpo-Ku

Sponsors (2)

Lead Sponsor	Collaborator
Hangang Sacred Heart Hospital	Translational Research Program for Rehabilitation Robots (NRCTR-EX19002)

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Bae YH, Ko YJ, Chang WH, Lee JH, Lee KB, Park YJ, Ha HG, Kim YH. Effects of Robot-assisted Gait Training Combined with Functional Electrical Stimulation on Recovery of Locomotor Mobility in Chronic Stroke Patients: A Randomized Controlled Trial. J Phys Ther Sci. 2014 Dec;26(12):1949-53. doi: 10.1589/jpts.26.1949. Epub 2014 Dec 25. — View Citation

Gawaziuk JP, Peters B, Logsetty S. Early ambulation after-grafting of lower extremity burns. Burns. 2018 Feb;44(1):183-187. doi: 10.1016/j.burns.2017.07.005. Epub 2017 Aug 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional ambulation category (FAC)	FAC was evaluated based on six scales. Scale 0 means that the patient cannot walk or can only walk with assistance of two people. Scale 5 means that the patient can walk independently.	12 weeks intervention
Primary	6-minute walking test (6MWT)	6MWT was performed in accordance with standardized guidelines, and the walking course was 20 m. Patients were instructed to walk as far as possible in 6 min	12 weeks intervention
Primary	Numeric rating scale (NRS) scores	Numeric rating scale (NRS) was used to rate the degree of subjective pain during gait movement: 0 points were assigned when no pain was noted, and unbearable pain was assigned 10 points.	12 weeks intervention
Secondary	frontal lobe cortial activity	A wearable functional near-infrared spectroscopy (fNIRS) device has been developed for studying cortical hemodynamics. Changes in cortical activity has not previously been documented in patients with burn injury. Cortical activity was measured by evaluating relative changes in oxyhemoglobin level. The NIRST Analysis Tool v2.1 was utilized to analyze fNIRS data in a MATLAB environment.	12 weeks intervention