An interventional study of Robot-assisted Gait Training in Burns, sponsored by Hangang Sacred Heart Hospital. Status unknown at 1 site in South Korea. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-10-23.
Sponsored by Hangang Sacred Heart Hospital · Not applicable, Interventional, and Treatment
This study aimed to elucidate the efficacy and investigate the mechanism of motor recovery after RAGT on patients with lower extremity burn. To investigate RAGT effects, we compare the results of RGAT group to the results of matched conventional(CON) rehabilitation group.
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. Contractures at the lower extremities such as the hip, knee, and ankle significantly limit gait. Recent studies focused on the application of robot-assisted gait training (RAGT).
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 wearable robot with a footplate that assists patients to perform voluntary muscle movements. 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 12 weeks. The CON group focused on gait training such as passive ROM exercise, weight bearing training, manual lymphatic drainage, and hypertrophic scar care for 60 min once a day for 5 days a week for 12 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. Cortical activity was measured by evaluating relative changes in oxyhemoglobin level. The NIRST Analysis Tool v2.1 was utilized to analyze fNIRS data in a MATLAB environment. Functional scores of functional ambulation category (FAC), 6-minute walking test (6MWT) distances, and numeric rating scale (NRS) scores of pain before and after 12 weeks RAGT 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. To evaluate functional recovery, FAC scores and 6-minute walking test (6MWT) distances were measured. 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. We measured walking-related cortical activity using an fNIRS device before and after 12 weeks RAGT.
730 studies on the registry are indexed under Burns; 146 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 534 interventional studies indexed under Burns.
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SUBAR® (CRETEM, Korea) is a wearable robot with a footplate that assists patients to perform voluntary muscle movements. 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 12 weeks.
Other: Robot-assisted Gait Training
SUBAR® (CRETEM, Korea) is a wearable robot with a footplate that assists patients to perform voluntary muscle movements. RAGT enables training of automatically programmed normal gait pattern.
Functional ambulation category (FAC)
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.
Time frame: 12 weeks intervention
6-minute walking test (6MWT)
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
Time frame: 12 weeks intervention
Numeric rating scale (NRS) scores
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.
Time frame: 12 weeks intervention
frontal lobe cortial activity
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. Cortical activity was measured by evaluating relative changes in oxyhemoglobin level. The NIRST Analysis Tool v2.1 was utilized to analyze fNIRS data in a MATLAB environment.
Time frame: 12 weeks intervention
Plan to share: Undecided
This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Hangang Sacred Heart Hospital