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
CRIS Registration Number |
KCT0005398 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Sungkyunkwan University |
Organization Type | University |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Sungkyunkwan University |
Organization Type | University |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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 |
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Arm Type Experimental |
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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 |
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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
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 |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 35Year~50Year |
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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. |
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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)
Type of Primary Outcome | clinical-equivalence | |
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Primary Outcome(s) 1 | ||
Outcome | Differences in quadriceps function between groups depending on whether virtual reality rehabilitation training content is applied or not |
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Timepoint | Before and after the four-week intervention program |
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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 |
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Timepoint | Before and after the four-week intervention program |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
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Time of Sharing | 2020. 12 |
Way of Sharing | Available on Request
(ays3804@naver.com) |
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