Effect on Gait Pattern During Robot Assisted Gait Training (RAGT) of End-effector Type in Burn Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHangang Sacred Heart Hospital
About this trial
This study aimed to investigate gait pattern and muscles power improvement of patient with gait disturbance caused by burns after end-effector type robot (Morning Walk®)-assited gait training (RAGT). This study randomly assigned 36 patients to one of two group : 30 minutes of Morning Walk® training with 30 minutes conventional physiotherapy (RAGT group) or 60 minutes of conventional physiotherapy (CON group). Five training sessions per week were given for 8 weeks. The primary outcomes were gait performance and muscles powers, which were assessed by the functional ambulation category (FAC) and the manual muscles test (MMT), respectively. The secondary outcomes included 6-minute walking test (6MWT), gait kinematic and spatiotemporal gait parameters. The results of this study is anticipated that the patients with gait disturbance receiving the RAGT might improve greater in gait performance and normal gait patterns that those trained with conventional physiotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who underwent split thickness skin graft (STSG) at Hangang Sacred Heart Hospital
with full or virtually full thickness involvement ( >50% of the body surface area of the lower extremity)
aged >18 years
with ≤ 1 functional ambulation category (FAC) score of ≤3 were included in this study.
Disqualifiers
who had fourth-degree burns (involving muscles, tendons, and bone injuries)
severe communication disorders due to intellectual impairment and psychologic problems
body weight > 135kg or height >195cm
physical status that could limit physical therapy (severe deformity or contracture of limbs, open wounds, or pressure ulcers, severe osteoporosis).
Trial design
Design model
Single group
Treatments tested in this trial
robot assisted gait training
Other interventionMorning Walk® is a new end-effector type robot developed by Hyundai Heavy Industries and Taeha Mechatronics for lower limb rehabilitation in the patients with gait disturbance.The RAGT group received RAGT with robot training for 30 minutes and conventional physiotherapy for 30 minutes per session.
conventional gait training
Other interventionThe control group received conventional physiotherapy for 60 minutes per session. Conventional physiotherapy consisted of 30 minutes of therapist-assisted gait and balance training and 30 minutes of strengthening exercises. The both group patients received five training sessions per week for 8 weeks (a total of 40 sessions).
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: robot assisted gait trainingExperimental treatment 2 interventions
Group B: conventioanl gait trainingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
functional ambulatory category
Ambulatory ability was rated by using the functional ambulatory category (FAC) scale.
Time frame
8 weeksSecondary outcomes
1
6 minute walking test
6MWT was performed in accordance with the standardised guidelines, and the walking course was 20 m. Patients were instructed to walk as far as possible in 6 min
Time frame
8 weeks2
gait parameters(cadence)
steps/minutes
Time frame
8 weeks3
gait parameters(gait speed)
Measure walking speed
Time frame
8 weeks4
gait parameters(step length)
Measure the distance between steps
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov