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The Effects of Robot-assisted Gait Training(RAGT) On Patients With Burn

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03992547
Enrollment
40
Registered
2019-06-20
Start date
2019-09-16
Completion date
2020-10-31
Last updated
2019-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns

Keywords

funcional near infrared spectroscopy, Robot-assisted gait training

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.

Interventions

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.

Sponsors

Translational Research Program for Rehabilitation Robots (NRCTR-EX19002)
CollaboratorUNKNOWN
Hangang Sacred Heart Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
6-minute walking test (6MWT)12 weeks intervention6MWT 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
Functional ambulation category (FAC)12 weeks interventionFAC 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.
Numeric rating scale (NRS) scores12 weeks interventionNumeric 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.

Secondary

MeasureTime frameDescription
frontal lobe cortial activity12 weeks interventionA 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.

Countries

South Korea

Contacts

Primary ContactSO YOUNG JOO, M.D.
anyany98@hallym.or.kr+82-2-2639-5735
Backup ContactCheong Hoon Seo, M.D.
chseomd@gmail.com+82 2 2639 5738

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026