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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-16

Study Completion Date

2020-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Burns

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Robot-assisted Gait Training

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No