Clinical trial NCT05988905: The Effects of Gait Performance and Brain Activity After Robot-assisted Gait Training (RAGT) On Patients With Lower Extremity Thermal Injury
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gait Disorder, Sensorimotor
Keywords: robot
burn patient
functional near-infrared spectroscopy
Lead sponsor: Hangang Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: robot assisted gait training
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: near infrared spectroscopy
timeFrame: 8 weeks
Secondary outcomes:
measure: numeric rating scale (NRS)
timeFrame: 8 weeks
measure: functional ambulatory category
timeFrame: 8 weeks
measure: 6 minutes walking test
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: handgang sacred heart hospital
name: SO YOUNG JOO, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Knaepen K, Mierau A, Swinnen E, Fernandez Tellez H, Michielsen M, Kerckhofs E, Lefeber D, Meeusen R. Human-Robot Interaction: Does Robotic Guidance Force Affect Gait-Related Brain Dynamics during Robot-Assisted Treadmill Walking? PLoS One. 2015 Oct 20;10(10):e0140626. doi: 10.1371/journal.pone.0140626. eCollection 2015.
citation: Hawkins KA, Fox EJ, Daly JJ, Rose DK, Christou EA, McGuirk TE, Otzel DM, Butera KA, Chatterjee SA, Clark DJ. Prefrontal over-activation during walking in people with mobility deficits: Interpretation and functional implications. Hum Mov Sci. 2018 Jun;59:46-55. doi: 10.1016/j.humov.2018.03.010. Epub 2018 Mar 29.