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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Effects of Robot-assisted Gait Training in Patients Burn Injury on Lower Extremity : a Randomized Controlled Trial

Conditions
-----------------
Burns, Gait Disorder, Sensorimotor

Intervention / Treatment
-----------------
* Device: Robot assisted gait training
* Other: conventional gait training


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: patients with full or virtually full thickness involvement of >50% on the body surface area of the lower extremity
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot assisted gait training<br>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. | Device: Robot assisted gait training<br>* 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.<br>|
| Active Comparator: conventional physical training group<br>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. | Other: conventional gait training<br>* even level gait training and range of motion exercises<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the changes of functional ambulatory category | 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. Higher scores mean a better outcome. | baseline, and after 12 weeks intervention | 
| the changes of 6 minutes walking test | 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. Higher scores mean a better outcome. | baseline, and after 12 weeks intervention | 
| the changes of visual analogue scale | Visual analogue scale 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. higher scores mean a worse outcome | baseline, and after 12 weeks intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the changes of active range of motion of flexion and extension | The active range of motion(ROM) of different joints was measured using a goniometer and an inclinometer with a standardized technique(hip joint) | baseline, and after 12 weeks intervention | 
| the changes of active range of motion of flexion and extension | The active range of motion(ROM) of different joints was measured using a goniometer and an inclinometer with a standardized technique(knee joint) | baseline, and after 12 weeks intervention | 
| the changes of active range of motion of dorsiflexion and plantarflexion | The active range of motion(ROM) of different joints was measured using a goniometer and an inclinometer with a standardized technique(ankle joint) | baseline, and after 12 weeks intervention | 
| the changes of isometric forces of knee flexion and knee extension | Isometric knee extension and knee flexion muscle strength were measured by handheld dynamometer. Two measurements were taken using handheld dynamometer. Each trial lasted for 3-5 s, with 30 second rest period between trials. The higher of the two valid measurements was recorded. | baseline, and after 12 weeks intervention | 
| the changes of isometric forces of ankle dorsiflexion and ankle plantarflexion | Isometric ankle dorsiflexion, and ankle plantar flexion muscle strength were measured by handheld dynamometer. Two measurements were taken using handheld dynamometer. Each trial lasted for 3-5 s, with 30 second rest period between trials. The higher of the two valid measurements was recorded. | baseline, and after 12 weeks intervention | 
| the changes of gait symmetry using stride length | Stride is the equivalent of a gait cycle. The duration of a stride is the interval between two sequential initial floor contacts by the same limb. symmetry ratio is defined with affected side stride length/ non affected side stride length. | baseline, and after 12 weeks intervention | 
| the changes of center of foot pressure pattern | center of foot pressure patten during a normal stride. longitudinal line analysis | baseline, and after 12 weeks intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
burns, rehabilitation, robot assisted gait training