Effects of Robot-assisted Gait Training in Patients Burn Injury on Lower Extremity

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

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-25

Study Completion Date

2020-02-24

Brief Summary

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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. Recent studies focused on the application of robot-assisted gait training (RAGT). This study aimed to elucidate the efficacy and investigate the mechanism of motor recovery after RAGT on patients with lower extremity burn.

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Detailed Description

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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.

20 patients with burn were randomly divided into 2 groups. RAGT group received RAGT 5 sessions per week at duration 30 minutes with 30 minutes conventional physical therapy in 12 weeks. SUBAR® (CRETEM, Korea) is a wearable robot with a footplate that assists patients to perform voluntary muscle movements. The conventional group underwent conventional physical therapy twice a day, 5 times a week in 12 weeks. Main outcomes were functional ambulatory category(FAC), 6 minutes walking test(6MWT), visual analogue scale(VAS), isometric forces of bilateral knee and ankle muscles, and foot pressure analysis before and after 12 weeks training.

Conditions

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Burns Gait Disorder, Sensorimotor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

patients with full or virtually full thickness involvement of \>50% on the body surface area of the lower extremity

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Robot assisted gait training

Robot assisted gait training(RAGT) group received RAGT 5 sessions per week at duration 30 minutes with 30 minutes conventional physical therapy in 12 weeks. SUBAR® (CRETEM, Korea) is a wearable robot with a footplate that assists patients to perform voluntary muscle movements.

Group Type EXPERIMENTAL

Robot assisted gait training

Intervention Type DEVICE

SUBAR® (CRETEM, Korea) is a wearable robot with a footplate that assists patients to perform voluntary muscle movements. RAGT group received RAGT 5 sessions per week at duration 30 minutes with 30 minutes conventional physical therapy in 12 weeks.

conventional physical training group

The conventional group underwent conventional physical therapy( even level gait training and range of motion exercises) twice a day, 5 times a week in 12 weeks.

Group Type ACTIVE_COMPARATOR

conventional gait training

Intervention Type OTHER

even level gait training and range of motion exercises

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 group received RAGT 5 sessions per week at duration 30 minutes with 30 minutes conventional physical therapy in 12 weeks.

Intervention Type DEVICE

conventional gait training

even level gait training and range of motion exercises

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients with full or virtually full thickness involvement of \>50% on the body surface area of the lower extremity
* age \> 18 years
* with ≤1 functional ambulation category (FAC) score ≤ 3

Exclusion Criteria

* patients with cognitive disorders before burn
* 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 RAGT and conventional rehabilitation
* patients with severe pain who were unable to undergo conventional rehabilitation programs.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No