Clinical trial NCT03992547: The Effects of Robot-assisted Gait Training(RAGT) On Patients With Burn
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: UNKNOWN
Phase: NA
Conditions: Burns
Keywords: funcional near infrared spectroscopy
Robot-assisted gait training
Lead sponsor: Hangang Sacred Heart Hospital
Sponsor class: OTHER
Collaborators: name: Translational Research Program for Rehabilitation Robots (NRCTR-EX19002)
First posted: 2019-06-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* the parients with lower extremity burn
* ≤1 functional ambulation category (FAC) score ≤ 3

Exclusion Criteria:

* 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 robot assisted gait training

Primary outcomes:
measure: Functional ambulation category (FAC)
timeFrame: 12 weeks intervention
measure: 6-minute walking test (6MWT)
timeFrame: 12 weeks intervention
measure: Numeric rating scale (NRS) scores
timeFrame: 12 weeks intervention
Secondary outcomes:
measure: frontal lobe cortial activity
timeFrame: 12 weeks intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hangang Sacred Heart Hospital
state: Yeongdeungpo-Ku
Study officials:
References:
citation: Gawaziuk JP, Peters B, Logsetty S. Early ambulation after-grafting of lower extremity burns. Burns. 2018 Feb;44(1):183-187. doi: 10.1016/j.burns.2017.07.005. Epub 2017 Aug 5.
citation: Bae YH, Ko YJ, Chang WH, Lee JH, Lee KB, Park YJ, Ha HG, Kim YH. Effects of Robot-assisted Gait Training Combined with Functional Electrical Stimulation on Recovery of Locomotor Mobility in Chronic Stroke Patients: A Randomized Controlled Trial. J Phys Ther Sci. 2014 Dec;26(12):1949-53. doi: 10.1589/jpts.26.1949. Epub 2014 Dec 25.