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Development of virtual reality rehabilitation contents for improvement of quadriceps muscle strength in patients with incomplete spinal cord injury

Status Approved

  • First Submitted Date

    2020/09/04

  • Registered Date

    2020/09/11

  • Last Updated Date

    2020/09/04

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005398
    Unique Protocol ID 2020-03-004-002
    Public/Brief Title Development of virtual reality rehabilitation contents for improvement of Thigh muscles strength in patients with incomplete spinal cord injury
    Scientific Title Development of virtual reality rehabilitation contents for improvement of quadriceps muscle strength in patients with incomplete spinal cord injury
    Acronym virtual reality -> VR spinal cord injury -> SCI ncomplete Spinal Cord Injury -> iSCI Time up and go -> TUG
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 2020-03-004-002
    Approval Date 2020-04-29
    Institutional Review Board Name Sungkyunkwan University Institutional Bioethics Committee
    Institutional Review Board Address 31, Seonggyungwan-ro, Jongno-gu, Seoul
    Institutional Review Board Telephone 031-290-5561
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name yeongsang jun an
    Title professor
    Telephone +82-31-290-5823
    Affiliation Sungkyunkwan University
    Address 94, Cheoncheon-ro, Jangan-gu, Suwon-si, Gyeonggi-do, Republic of Korea
    Contact Person for Public Queries
    Name An yeong sang
    Title Researcher
    Telephone +82-42-488-2234
    Affiliation Sungkyunkwan University
    Address 94, Cheoncheon-ro, Jangan-gu, Suwon-si, Gyeonggi-do, Republic of Korea
    Contact Person for Updating Information
    Name An yeong sang
    Title Researcher
    Telephone +82-2-488-2234
    Affiliation Sungkyunkwan University
    Address 94, Cheoncheon-ro, Jangan-gu, Suwon-si, Gyeonggi-do, Republic of Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2020-04-30 Actual
    Target Number of Participant 40
    Primary Completion Date 2020-06-30 , Actual
    Study Completion Date 2020-07-31 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Sungkyunkwan University
    Recruitment Status Completed
    Date of First Enrollment 2020-04-30 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Sungkyunkwan University
    Organization Type University
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Sungkyunkwan University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    This study aims to solve the discomfort of patients undergoing rehabilitation treatment in the hospital every day by making the quadriceps exercise anywhere using virtual reality programs.  Besides, we intend to produce high immersion VR programs encouraging interest and internal motivation for the patients to perform active and periodic rehabilitation treatment themselves.
       We studied the degree of functional improvement of the quadriceps muscle and living performance through forty participants who repeatedly exercise for rehab using our programs. Among the volunteers, twenty people each were divided into an experimental group and a control group. They were all diagnosed with incomplete spinal cord injury and were C5-C7 ASIA C, D cervical level SCI injury patients. Besides, they consisted of the quadriceps muscle strength Fair (only possible to overcome gravity) grade without limitations on the range of motion(Before the study, they have checked their physical fitness performance such as chair stand test, time up and go(TUG) and 10m walking test).
       First, the experimental group exercises with the VR experience. For example, a user wearing an HMD(Head Mounted Display) and leg controller kicks a soccer ball repeatedly in 3 seconds and gets points in virtual reality space. Additionally, the participant needs to stretch his knee more than 45 degrees for 3 seconds If it's an iron ball. Total 20 Balls roll in the space for one minute, and those are 80% soccer ball and 20% iron ball. Meanwhile, the control group practices stretching legs following only therapists' orders, but the way to count scores is the same.  
       After the practice, consequently, there was no difference in physical fitness performance between the experimental and control ones. Both teams showed equally better movement for the given tests, except knee extension score.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
     Supportive Care
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Single
    Blinded Subject Subject
    Allocation RCT
    Intervention Type Medical Device, Behavioral, Others (Rehabilitation intervention using virtual reality contents)
    Intervention Description
    All participants of the experiment performed 12 sessions for 4 weeks, 30 minutes per session, and exercised in a manner of taking 1 minute rest after 1 minute exercise. During the 1-minute exercise, a total of 20 knee extension exercises are performed, and 10 times are performed at random on the left and right. The exercise program consists of 8 times per leg for lowering immediately after the knee extension exercise, and 2 times per leg for lowering after maintaining the knee extension for more than 3 seconds. All knee extension exercises are actively performed and do not pull to other parts of the patient's body or assist with movement around the patient. The exercise starts with a 90-degree knee bent while sitting in a wheelchair, and one time when the knee is extended over 45 degrees was considered.
    
    The experimental group performed rehabilitation while sitting in a wheelchair, wearing an HMD on the head, and wearing a lower extremity input device for recognizing leg motion data on both legs. In virtual reality content, when the ball approaches, the audio-visual signal was provided through sound effects that require the legs to be lifted. The professional therapist was observing for safety and was not involved in rehabilitation except for the first and last MMT, ROM, ASIA scale diagnosis check, chair stand test, TUG test, 10m walking test, and instruction on how to use the contents.
    The control group performed rehabilitation while sitting in a wheelchair and wearing lower extremity input devices that recognize motion data on both legs. The control group did not use virtual reality content, and the worn lower extremity input device created an environment similar to that of the experimental group and was used as an experimental data collection device.
       The knee extension exercise was performed the same number of times as the experimental group by the therapist's voice instruction. There was no involvement in rehabilitation except for the first and last MMT, ROM, ASIA scale diagnosis confirmation, chair stand test, TUG test, 10m walking test, exercise method training and voice instruction.
    Number of Arms 2
    Arm 1

    Arm Label

    Quadriceps rehabilitation group using virtual reality contents

    Target Number of Participant

    20

    Arm Type

    Experimental

    Arm Description

    The experimental group performed rehabilitation while sitting in a wheelchair, wearing an HMD on the head, and wearing a lower extremity input device for recognizing leg motion data on both legs. In virtual reality content, when the ball approaches, the audio-visual signal was provided through sound effects that require the legs to be lifted. The professional therapist was observing for safety and was not involved in rehabilitation except for the first and last MMT, ROM, ASIA scale diagnosis check, chair stand test, TUG test, 10m walking test, and instruction on how to use the contents.
    Arm 2

    Arm Label

    Quadriceps rehabilitation group through voice instruction from therapist

    Target Number of Participant

    20

    Arm Type

    Active comparator

    Arm Description

    The control group performed rehabilitation while sitting in a wheelchair and wearing lower extremity input devices that recognize motion data on both legs. The control group did not use virtual reality content, and the worn lower extremity input device created an environment similar to that of the experimental group and was used as an experimental data collection device.
       The knee extension exercise was performed the same number of times as the experimental group by the therapist's voice instruction. There was no involvement in rehabilitation except for the first and last MMT, ROM, ASIA scale diagnosis confirmation, chair stand test, TUG test, 10m walking test, exercise method training and voice instruction.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (S00-T98)Injury, poisoning and certain other consequences of external causes 
       (T09.3)Injury of spinal cord, level unspecified 

    incomplete spinal cord injury Penetrating and non-penetrating injuries to the spinal cord resulting from traumatic external forces Injuries, Spinal Cord Myelopathy, Traumatic Post-Traumatic Myelopathy Spinal Cord Contusion Spinal Cord Laceration Spinal Cord Transection Spinal Cord Trauma
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    35Year~50Year

    Description

    This study was conducted on patients diagnosed with incomplete spinal cord injury, and 40 patients with AISA disability scales C and D were randomly classified into 20 patients in the experimental group and 20 patients in the control group and intervened (Park, 2011). Patients with C5-C7 level of cervical spine injury were selected with grade F of quadriceps muscle strength, and patients with no ROM limitations were selected.
    Exclusion Criteria
    Patients who underwent surgical operation within 6 months prior to the study, or those with musculoskeletal injury with fractures or contractures were excluded from the experiment.
    Healthy Volunteers
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome clinical-equivalence
    Primary Outcome(s) 1
    Outcome
    Differences in quadriceps function between groups depending on whether virtual reality rehabilitation training content is applied or not
    Timepoint
    Before and after the four-week intervention program
    Secondary Outcome(s) 1
    Outcome
    Differences in the function of the quadriceps muscle before and after rehabilitation exercise according to the application of virtual reality content
    Timepoint
    Before and after the four-week intervention program
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2020. 12
    Way of Sharing Available on Request
    (ays3804@naver.com)
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