Effects of Robot-assisted Gait Training in Patients Burn Injury on Lower Extremity
- Conditions
- Gait Disorder, SensorimotorBurns
- Interventions
- Other: conventional gait trainingDevice: Robot assisted gait training
- Registration Number
- NCT04281394
- Lead Sponsor
- Hangang Sacred Heart Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description conventional physical training group conventional gait training 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. Robot assisted gait training 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
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.
Trial Locations
- Locations (1)
Hangang Sacred Heart Hospital
🇰🇷Seoul, Yeong-deungpo-Dong, Korea, Republic of