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

Hangang Sacred Heart Hospital

Status: Completed

Conditions: Gait Disorder, Sensorimotor; Burns

Treatments: Device: Robot assisted gait training; Other: conventional gait training

Study type: Interventional

Funder types: Other

Identifiers

NCT04281394

HangangSHH-8

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

28 participants in 2 patient groups

Robot assisted gait training

Experimental group

Description:

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.

Treatment:

Device: Robot assisted gait training

conventional physical training group

Active Comparator group

Description:

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.

Treatment:

Other: conventional gait training