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The Effects of Gait Performance and Brain Activity After Robot-assisted Gait Training (RAGT) On Patients With Lower Extremity Thermal Injury

Primary Purpose

Gait Disorder, Sensorimotor

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
robot assited gati training
conventional traiing
Sponsored by
Hangang Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gait Disorder, Sensorimotor focused on measuring robot, burn patient, functional near-infrared spectroscopy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    robot assisted gait training

    conventioanl training

    Arm Description

    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 conventional training 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.

    Outcomes

    Primary Outcome Measures

    near infrared spectroscopy
    The rest period before gait period served as a baseline reference for osyhemoglobin of PFC perfusion. Cortical activity was measured by evaluating relative changes in oxyhemoglobin level and deoxyhemoglobin level.

    Secondary Outcome Measures

    numeric rating scale (NRS)
    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.
    functional ambulatory category
    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.
    6 minutes walking test
    Patients were instructed to walk as far as possible in 6 min

    Full Information

    First Posted
    August 3, 2023
    Last Updated
    August 15, 2023
    Sponsor
    Hangang Sacred Heart Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05988905
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    March 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hangang Sacred Heart Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gait Disorder, Sensorimotor
    Keywords
    robot, burn patient, functional near-infrared spectroscopy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    robot assisted gait training
    Masking
    Outcomes Assessor
    Masking Description
    Robot assisted gait training 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.
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    robot assisted gait training
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    conventioanl training
    Arm Type
    Active Comparator
    Arm Description
    The conventional training 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.
    Intervention Type
    Other
    Intervention Name(s)
    robot assited gati training
    Intervention Description
    SUBAR® (CRETEM, Korea) is a exoskeletal-robot with a footplate that assists gait movements. The patient's thigh length and lower leg length were measured before training, so that the SUBAR® can be adjusted to patient's size to ensure accurate training. During training, the therapist facilitated the treatment and stood by the patients' side to adjust the direction and speed. RAGT is programmed automatically, and it can be performed regularly over a long period. The patients received 30 min of robot-assisted training using SUBAR® once a day for 5 days a week for 8 weeks. Each training session lasted up to 40 min.
    Intervention Type
    Other
    Intervention Name(s)
    conventional traiing
    Intervention Description
    Patients also received conventional exercise rehabilitation with the same duration and frequency. Conventional rehabilitation therapy, which consisted of active assistive knee exercises, knee stretching, patellar mobilization exercises, and quadriceps setting exercises, was performed every day throughout the rehabilitation period.
    Primary Outcome Measure Information:
    Title
    near infrared spectroscopy
    Description
    The rest period before gait period served as a baseline reference for osyhemoglobin of PFC perfusion. Cortical activity was measured by evaluating relative changes in oxyhemoglobin level and deoxyhemoglobin level.
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    numeric rating scale (NRS)
    Description
    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.
    Time Frame
    8 weeks
    Title
    functional ambulatory category
    Description
    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.
    Time Frame
    8 weeks
    Title
    6 minutes walking test
    Description
    Patients were instructed to walk as far as possible in 6 min
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sung Rakyum
    Phone
    82-2-2639-5900
    Email
    sung6652@hallym.or.kr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    SO YOUNG JOO, MD
    Organizational Affiliation
    handgang sacred heart hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26485148
    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.
    Results Reference
    result
    PubMed Identifier
    29604488
    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.
    Results Reference
    result

    Learn more about this trial

    The Effects of Gait Performance and Brain Activity After Robot-assisted Gait Training (RAGT) On Patients With Lower Extremity Thermal Injury

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