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

Primary Purpose

Burns

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Robot-assisted Gait Training
Sponsored by
Hangang Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring funcional near infrared spectroscopy, Robot-assisted gait training

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hangang Sacred Heart HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

robot assisted gait traing

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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
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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 18, 2019
Last Updated
October 22, 2019
Sponsor
Hangang Sacred Heart Hospital
Collaborators
Translational Research Program for Rehabilitation Robots (NRCTR-EX19002)
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1. Study Identification

Unique Protocol Identification Number
NCT03992547
Brief Title
The Effects of Robot-assisted Gait Training(RAGT) On Patients With Burn
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 16, 2019 (Actual)
Primary Completion Date
July 30, 2020 (Anticipated)
Study Completion Date
October 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangang Sacred Heart Hospital
Collaborators
Translational Research Program for Rehabilitation Robots (NRCTR-EX19002)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
funcional near infrared spectroscopy, Robot-assisted gait training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
robot assisted gait traing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Robot-assisted Gait Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional ambulation category (FAC)
Description
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.
Time Frame
12 weeks intervention
Title
6-minute walking test (6MWT)
Description
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
Time Frame
12 weeks intervention
Title
Numeric rating scale (NRS) scores
Description
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.
Time Frame
12 weeks intervention
Secondary Outcome Measure Information:
Title
frontal lobe cortial activity
Description
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.
Time Frame
12 weeks intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SO YOUNG JOO, M.D.
Phone
+82-2-2639-5735
Email
anyany98@hallym.or.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Cheong Hoon Seo, M.D.
Phone
+82 2 2639 5738
Email
chseomd@gmail.com
Facility Information:
Facility Name
Hangang Sacred Heart Hospital
City
Seoul
State/Province
Yeongdeungpo-Ku
ZIP/Postal Code
150-719,
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28789801
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.
Results Reference
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PubMed Identifier
25540505
Citation
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.
Results Reference
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The Effects of Robot-assisted Gait Training(RAGT) On Patients With Burn

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