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

Sponsor

Hangang Sacred Heart Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04281394

Collaborator

Ministry of Health, Republic of Korea (Other)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Burns Gait Disorder, Sensorimotor	Device: Robot assisted gait training Other: conventional gait training	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 25, 2019

Actual Primary Completion Date :

Feb 24, 2020

Actual Study Completion Date :

Feb 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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.
Active Comparator: 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.	Other: conventional gait training even level gait training and range of motion exercises

Arm

Intervention/Treatment

Experimental: 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.

Device: 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.

Active Comparator: 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.

Other: conventional gait training

even level gait training and range of motion exercises

Outcome Measures

Primary Outcome Measures

the changes of functional ambulatory category [baseline, and after 12 weeks intervention]
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.
the changes of 6 minutes walking test [baseline, and after 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. Higher scores mean a better outcome.
the changes of visual analogue scale [baseline, and after 12 weeks intervention]
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

Secondary Outcome Measures

the changes of active range of motion of flexion and extension [baseline, and after 12 weeks intervention]
The active range of motion(ROM) of different joints was measured using a goniometer and an inclinometer with a standardized technique(hip joint)
the changes of active range of motion of flexion and extension [baseline, and after 12 weeks intervention]
The active range of motion(ROM) of different joints was measured using a goniometer and an inclinometer with a standardized technique(knee joint)
the changes of active range of motion of dorsiflexion and plantarflexion [baseline, and after 12 weeks intervention]
The active range of motion(ROM) of different joints was measured using a goniometer and an inclinometer with a standardized technique(ankle joint)
the changes of isometric forces of knee flexion and knee extension [baseline, and after 12 weeks intervention]
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.
the changes of isometric forces of ankle dorsiflexion and ankle plantarflexion [baseline, and after 12 weeks intervention]
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.
the changes of gait symmetry using stride length [baseline, and after 12 weeks intervention]
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.
the changes of center of foot pressure pattern [baseline, and after 12 weeks intervention]
center of foot pressure patten during a normal stride. longitudinal line analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.