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

October 22, 2019 updated by: Hangang Sacred Heart Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Yeongdeungpo-Ku
      • Seoul, Yeongdeungpo-Ku, Korea, Republic of, 150-719,
        • Recruiting
        • Hangang Sacred Heart Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: robot assisted gait traing
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional ambulation category (FAC)
Time Frame: 12 weeks intervention
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
6-minute walking test (6MWT)
Time Frame: 12 weeks intervention
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
Numeric rating scale (NRS) scores
Time Frame: 12 weeks intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
frontal lobe cortial activity
Time Frame: 12 weeks intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hangang Sacred Heart Hospital

Collaborators

Translational Research Program for Rehabilitation Robots (NRCTR-EX19002)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 16, 2019

Primary Completion (ANTICIPATED)

July 30, 2020

Study Completion (ANTICIPATED)

October 31, 2020

Study Registration Dates

First Submitted

June 18, 2019

First Submitted That Met QC Criteria

June 18, 2019

First Posted (ACTUAL)

June 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 23, 2019

Last Update Submitted That Met QC Criteria

October 22, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HangangSHH-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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