The Effects of Gait Performance and Brain Activity After Robot-assisted Gait Training (RAGT) On Patients With Lower Extremity Thermal Injury
- Conditions
- Gait Disorder, Sensorimotor
- Interventions
- Other: robot assited gati trainingOther: conventional traiing
- Registration Number
- NCT05988905
- Lead Sponsor
- Hangang Sacred Heart Hospital
- Brief Summary
Gait enables individuals to move forward and is considered a natural skill. Gait disturbances are very common in patients with burn injury. Major causes of gait disturbances are pain and joint contractures. Recent studies focused on the application of robot-assisted gait training (RAGT) for improving gait functions. This study aimed to elucidate the efficacy and investigate the mechanism of motor recovery after RAGT on patients with lower extremity burn. To investigate the clinical effects, the investigators compare the results of RAGT group to the results of matched conventional (CON) rehabilitation group.This single-blinded, randomized, controlled trial involved 40 patients with lower extremity burns. Patients were randomized into a RAGT or a CON group. SUBAR® (CRETEM, Korea) is a exoskeletal-robot with a footplate that assists patients to perform gait motions. RAGT enables training of automatically programmed normal gait pattern. Patients underwent 30 min of RAGT using SUBAR® and conventional exercise rehabilitation each for 30 min once a day for 5 days a week for 8 weeks. The CON group focused on gait training such as active range of motion (ROM) exercise, weight bearing training, manual lymphatic drainage, and hypertrophic scar care for 60 min once a day for 5 days a week for 8 weeks.A wearable functional near-infrared spectroscopy (fNIRS) device has been developed for studying cortical hemodynamics. Changes in cortical activity has not previously been documented in patients with burn injury. The primary outcome was the prefrontal cortical activity in the both groups. The walking-related cortical activity using an fNIRS device before and after 8 weeks training were measured. To evaluate functional recovery, functional ambulation category (FAC) scores and 6-minute walking test (6MWT) distances were measured. Numeric rating scale (NRS) 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.
- Detailed Description
Gait enables individuals to move forward and is considered a natural skill. Gait disturbances are very common in patients with burn injury. Major causes of gait disturbances are pain and joint contractures. Recent studies focused on the application of robot-assisted gait training (RAGT) for improving gait functions. This study aimed to elucidate the efficacy and investigate the mechanism of motor recovery after RAGT on patients with lower extremity burn. To investigate the clinical effects, the investigators compare the results of RAGT group to the results of matched conventional (CON) rehabilitation group.This single-blinded, randomized, controlled trial involved 40 patients with lower extremity burns. Patients were randomized into a RAGT or a CON group. SUBAR® (CRETEM, Korea) is a exoskeletal-robot with a footplate that assists patients to perform gait motions. RAGT enables training of automatically programmed normal gait pattern. Patients underwent 30 min of RAGT using SUBAR® and conventional exercise rehabilitation each for 30 min once a day for 5 days a week for 8 weeks. The CON group focused on gait training such as active range of motion (ROM) exercise, weight bearing training, manual lymphatic drainage, and hypertrophic scar care for 60 min once a day for 5 days a week for 8 weeks.A wearable functional near-infrared spectroscopy (fNIRS) device has been developed for studying cortical hemodynamics. Changes in cortical activity has not previously been documented in patients with burn injury. The primary outcome was the prefrontal cortical activity in the both groups. The walking-related cortical activity using an fNIRS device before and after 8 weeks training were measured. To evaluate functional recovery, functional ambulation category (FAC) scores and 6-minute walking test (6MWT) distances were measured. Numeric rating scale (NRS) 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- patients with full or virtually full thickness involvement of >50% on the body surface area of the bilateral lower extremity
- age > 18 years
- with ≤1 functional ambulation category (FAC) score ≤ 3
- patients with cognitive disorders
- intellectual impairment before burn injury
- 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 robot assisted gait training robot assited gati training RAGT enables training of automatically programmed normal gait pattern. Patients underwent 30 min of RAGT using SUBAR® and conventional exercise rehabilitation each for 30 min once a day for 5 days a week for 8 weeks. conventioanl training conventional traiing The conventional training group focused on gait training such as active range of motion (ROM) exercise, weight bearing training, manual lymphatic drainage, and hypertrophic scar care for 60 min once a day for 5 days a week for 8 weeks.
- Primary Outcome Measures
Name Time Method near infrared spectroscopy 8 weeks The rest period before gait period served as a baseline reference for osyhemoglobin of PFC perfusion. Cortical activity was measured by evaluating relative changes in oxyhemoglobin level and deoxyhemoglobin level.
- Secondary Outcome Measures
Name Time Method functional ambulatory category 8 weeks FAC was evaluated based on six scales. 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.
numeric rating scale (NRS) 8 weeks 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.
6 minutes walking test 8 weeks Patients were instructed to walk as far as possible in 6 min