Effects of Robot-assisted Gait Training in Patients Burn Injury on Lower Extremity : a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- the changes of functional ambulatory category
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Robot assisted gait training (Device)
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.
Intervention: conventional gait training (Other)
Outcomes
Primary Outcomes
the changes of functional ambulatory category
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- the changes of active range of motion of flexion and extension(baseline, and after 12 weeks intervention)
- the changes of gait symmetry using stride length(baseline, and after 12 weeks intervention)
- the changes of center of foot pressure pattern(baseline, and after 12 weeks intervention)
- the changes of active range of motion of dorsiflexion and plantarflexion(baseline, and after 12 weeks intervention)
- the changes of isometric forces of knee flexion and knee extension(baseline, and after 12 weeks intervention)
- the changes of isometric forces of ankle dorsiflexion and ankle plantarflexion(baseline, and after 12 weeks intervention)