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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03992547
Other study ID # HangangSHH-4
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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:

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Study Design


Related Conditions & MeSH terms


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
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