Gait Disorder, Sensorimotor Clinical Trial
Official title:
The Effects of Gait Performance and Brain Activity After Robot-assisted Gait Training (RAGT) On Patients With Lower Extremity Thermal Injury : a Prospective, Randomized, Single-blinded Study
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04281394 -
Effects of Robot-assisted Gait Training in Patients Burn Injury on Lower Extremity
|
N/A | |
Completed |
NCT04681235 -
Virtual Reality Training Affects on Motor Functions and Mental Health in Stroke Patients
|
N/A | |
Recruiting |
NCT05967078 -
ExerG: Video Game-based Physical Cognitive Training for Patients: a Usability Study
|
N/A | |
Not yet recruiting |
NCT05692791 -
Idiopathic Toe-Walking Position Sensation
|
||
Completed |
NCT02310841 -
Pilot Study for Patient-cooperative Control Strategies for Actuated Transfemoral Prostheses
|
N/A | |
Not yet recruiting |
NCT05883917 -
Clinical Utility of Robot-Assisted Gait Training in Patients With Spinal Cord Injury Caused by Electrical Burns: A Case Report
|
N/A | |
Not yet recruiting |
NCT05886166 -
Clinical Utility of Exoskeleton Robot Training in Patients With Septic Arthritis After a Thermal Injury: A Case Report
|
N/A | |
Recruiting |
NCT04947865 -
Reflex Excitability in Post-stroke Stiff-Knee Gait
|
N/A | |
Recruiting |
NCT03869879 -
Mobility Rehab, a Therapist-assisted System for Gait Rehabilitation
|
N/A | |
Completed |
NCT04062292 -
Gait Parameters and Balance in Patients With Obstructive Lung Diseases
|
||
Completed |
NCT03015714 -
Aquatic Therapy for Freezing of Gait in Parkinson's Disease Patients
|
N/A | |
Completed |
NCT01635348 -
Thinking, Walking Outcomes by Type of Exercise
|
Phase 2 | |
Recruiting |
NCT05218187 -
Robotic Gait Rehabilitation in Parkinson's Disease
|
Phase 1/Phase 2 | |
Completed |
NCT04054076 -
10 Years Follow-up Study of Plantar Pressure, Kinetics and Kinematics in a Cohort of Patients Diagnosed With Diabetes
|
N/A | |
Completed |
NCT04491162 -
The Effect of Body Weight Support Treadmill Training on Lower Limb Function in Patients With Chronic Stroke
|
N/A | |
Completed |
NCT03343132 -
Gait Adaptability: Tracking Locomotor Recovery After Incomplete Spinal Cord Injury
|
||
Completed |
NCT04758364 -
Factors That Effect the Gait Speed in Diabetic Individuals Without Neuropathy
|
||
Completed |
NCT03057522 -
Step Rate in Recreational Runners
|
N/A | |
Completed |
NCT05127538 -
Balance and Gait in Diabetic Neuropathy
|
N/A | |
Completed |
NCT03769220 -
Evaluation of the Measurement Properties of a 5 Time Repeated Instrumented Timed Up and Go (5iTUG)
|