Status Approved
First Submitted Date
2021/03/24
Registered Date
2021/04/05
Last Updated Date
2021/03/23
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
| CRIS Registration Number |
KCT0006053 |
|---|---|
| Unique Protocol ID | 1041478-2017-HR-016 |
| Public/Brief Title | A study to prevent falls of the elderly by implementing a Virtual Reality program and Motor imagery training that can be easily applied indoors to the elderly |
| Scientific Title | Effects of Virtual Reality Program and Motor Imagery Training on Plantar Pressure, Balance Ability, Depression and Falls Eff |
| Acronym | |
| 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 |
|---|---|
| Board Approval Number | 1041478-2017-HR-016 |
| Approval Date | 2017-11-08 |
| Institutional Review Board Name | Nambu University Institutional Review Board |
| Institutional Review Board Address | 23, Cheomdanjungang-ro, Gwangsan-gu, Gwangju |
| Institutional Review Board Telephone | 062-970-0051 |
| Data Monitoring Committee | No |
3. Contact Details
| Contact Person for Principal Investigator / Scientific Queries | |
|---|---|
| Name | Cho Sung Hyoun |
| Title | professor |
| Telephone | +82-62-970-0232 |
| Affiliation | Nambu University |
| Address | 1 Namdae-gil, Gwangsan-gu, Gwangju |
| Contact Person for Public Queries | |
| Name | Kim So Hyun |
| Title | MS |
| Telephone | +82-62-970-0232 |
| Affiliation | Nambu University |
| Address | 1 Namdae-gil, Gwangsan-gu, Gwangju |
| Contact Person for Updating Information | |
| Name | Kim So Hyun |
| Title | MS |
| Telephone | +82-62-970-0232 |
| Affiliation | Nambu University |
| Address | 1 Namdae-gil, Gwangsan-gu, Gwangju |
4. Status
| Study Site | Single | |
|---|---|---|
| Overall Recruitment Status | Completed | |
| Date of First Enrollment | 2017-11-09 Actual | |
| Target Number of Participant | 36 | |
| Primary Completion Date | 2017-12-29 , Actual | |
| Study Completion Date | 2017-12-29 , Actual | |
| Recruitment Status by Participating Study Site 1 | ||
| Name of Study | Nambu University | |
| Recruitment Status | Completed | |
| Date of First Enrollment | 2017-11-09 , | |
5. Source of Monetary / Material Support
| 1. Source of Monetary/Material Support | |
|---|---|
| Organization Name | Nambu University |
| Organization Type | University |
| Project ID | 1041478-2017-HR-016 |
6. Sponsor Organization
| 1. Sponsor Organization | |
|---|---|
| Organization Name | Nambu University |
| Organization Type | University |
7. Study Summary
| Lay Summary | 1. Abstract This study was conducted to compare plantar pressure, balance ability, depression, and falls efficacy by applying effective virtual reality program and motor imagery training into gait, balance ability, depression, and falls efficacy of elderly people with high prevalence of falls efficacy in an aging society and examine whether it is valid and effective intervention to prevent them from falling in medical rehabilitation. 36 normal elderly people were randomly assigned into a virtual reality group (12), motor imagery training group (12), and control group (12), except for two ineligible participants. In sum, 34 participants including virtual reality group (12), motor imagery training group (10), and control group (12) joined this study. For therapeutic intervention, the virtual reality group underwent for half an hour three times for six weeks, motor imagery training group performed for 20 minutes three times for six weeks, while no intervention was implemented in the control group. Each group conducted test prior to training and follow-up research was performed two weeks after assessment on the sixth week when training was completed in order to identify therapeutic intervention effects among groups. Gaitview (Alfoots Co., Korea) was used to measure plantar pressure, proximal transfer area, and sense of balance of opening and closing eyes. Timed up and go was performed to measure dynamic balance ability. The degree of depression was measured by Geriatric depression scale (GDS) and falls efficacy was assessed by using Falls efficacy scale (FES). 2. Hypothesis A. There will be a difference between the timing of virtual reality programs and motor imagery training and static foot pressure among groups. B. There will be differences in timing of virtual reality programs and motor imagery training and dynamic foot pressure between groups. C. There will be a difference between the timing of virtual reality programs and motor imagery training and the ability to balance static among groups. D. There will be differences between the timing of virtual reality programs and motor imagery training and the TUG between groups. E. There will be a difference between the timing of virtual reality programs and motor imagery training and the degree of depression among groups. F. There will be a difference between the timing of virtual reality programs and motor imagery training and the fall effectiveness between groups. |
|---|
8. Study Design
| Study Type | Interventional Study |
|---|---|
| Study Purpose | Prevention |
| Phase | Not applicable |
| Intervention Model | Factorial |
| Blinding/Masking | Single |
| Blinded Subject | Subject |
| Allocation | RCT |
| Intervention Type | Medical Device |
| Intervention Description | 36 normal elderly people were randomly assigned into a virtual reality group (12), motor imagery training group (12), and control group (12), except for two ineligible participants. In sum, 34 participants including virtual reality group (12), motor imagery training group (10), and control group (12) joined this study. For therapeutic intervention, the virtual reality group underwent for half an hour three times for six weeks, motor imagery training group performed for 20 minutes three times for six weeks, while no intervention was implemented in the control group. |
| Number of Arms | 3 |
| Arm 1 |
Arm Label virtual reality group |
|
Target Number of Participant 12 |
|
|
Arm Type Experimental |
|
|
Arm Description The virtual reality program was carried out for a total of 6 weeks, 30 minutes a day, 3 times a week, and a total of 30 minutes was performed with 5 minutes of warm-up stretching, 5 minutes of each program, and 5 minutes of rest period. |
|
| Arm 2 |
Arm Label motor imagery training group |
|
Target Number of Participant 12 |
|
|
Arm Type Experimental |
|
|
Arm Description The motor imagery training was carried out for a total of 6 weeks, 20 minutes a day, 3 times a week, and it is recommended to train the subject within 20 minutes for the motor imagery training time. Each 2.5 minutes of relaxation was induced before and after the start of the motor imagery training, and the motor sensory image training and visual image training were performed for 15 minutes, and a total of 20 minutes of the main training was performed. |
|
| Arm 3 |
Arm Label control group |
|
Target Number of Participant 12 |
|
|
Arm Type No intervention |
|
|
Arm Description The control group did not implement any treatment interventions. |
9. Subject Eligibility
| Condition(s)/Problem(s) |
* (R00-R99)Symptoms, signs and abnormal clinical and laboratory findings, NEC (R54)Senility ○○ 36 healthy elderly people aged 65 or older who were hospitalized at S nursing hospital in the metropolitan area were divided into 12 virtual reality groups, 12 motor imagery training groups, and 12 control groups.It was conducted under the simple random sampling method, but a total of 34 people participated in the study as two motor imagery training groups were eliminated in the preliminary survey. |
|---|---|
| Rare Disease | No |
| Inclusion Criteria |
Gender Both |
|
Age 65Year~No Limit |
|
|
Description A. Korean mini-mental status assessment (MMSE-K) score of 24 or higher B. Vividness of movement imagination questionnaire (VMIQ) score 2.26 or less C. Those who are not impaired in vestibular function, vision, and hearing. D. Persons who can walk independently of their daily lives E. Musculoskeletal lesions and persons without surgery history within the last six months F. A person who does not take medication that affects his or her balance ability. G. Those who have not been exercising regularly for the last six months to affect the experiment. H. Those who do not have progressive or neurological disorders (stroke, dementia, Parkinson's disease, etc.) I. A person who voluntarily agreed to this study |
|
| Exclusion Criteria |
A. A person who does not meet the selection criteria B. Who wants to stop research while it's in progress |
| Healthy Volunteers | No |
10. Outcome Measure(s)
| Type of Primary Outcome | Efficacy | |
|---|---|---|
| Primary Outcome(s) 1 | ||
| Outcome | Plantar pressure(Static, Dynamic) |
|
| Timepoint | Pre-test(0 week), Post-test(6 week), Follow-up(8 week) |
|
| Primary Outcome(s) 2 | ||
| Outcome | Movement area about in the central of the body |
|
| Timepoint | Pre-test(0 week), Post-test(6 week), Follow-up(8 week) |
|
| Primary Outcome(s) 3 | ||
| Outcome | balance sensory when people stick to opening eyes |
|
| Timepoint | Pre-test(0 week), Post-test(6 week), Follow-up(8 week) |
|
| Primary Outcome(s) 4 | ||
| Outcome | balance sensory when people stick to closing eyes |
|
| Timepoint | Pre-test(0 week), Post-test(6 week), Follow-up(8 week) |
|
| Primary Outcome(s) 5 | ||
| Outcome | Timed up and go(TUG) |
|
| Timepoint | Pre-test(0 week), Post-test(6 week), Follow-up(8 week) |
|
| Primary Outcome(s) 6 | ||
| Outcome | Depression |
|
| Timepoint | Pre-test(0 week), Post-test(6 week), Follow-up(8 week) |
|
| Secondary Outcome(s) 1 | ||
| Outcome | Falls efficacy |
|
| Timepoint | Pre-test(0 week), Post-test(6 week), Follow-up(8 week) |
|
11. Study Results and Publication
| Result Registered |
Yes
Results Upload |
|---|---|
| Final Enrollment Number | 34 |
| Number of Publication | 0 |
| Results Upload | cris.hwp |
| Date of Posting Results | 2021/04/05 |
| Protocol URL or File Upload | |
| Brief Summary | As a result of this study, the three periods and group interactions were statistically significant in all variables (p<.05). According to the period, the virtual reality program showed significant difference in both plantar pressure (p<.05), and there was no significant difference in motor imagery training only in left and right static plantar pressure (p>.05). The static balance ability was significantly different in both the virtual reality group and the motor imagery training group than before training in the body center movement area (p<.05). In addition, there was a significant difference in the sense of balance during opening and closing eyes in the virtual reality group (p<.05), but there was no significant difference in the image training group (p>.05). There were significant differences in TUG, depression, and fall efficacy in both groups (p<.05). In the post-test (6 weeks), there was a significant difference between the virtual reality group and the control group, the motor imagery training group and the control group (p<.05). TUG showed a significant difference between the virtual reality group and the control group in the post-test (6 weeks) (p<.05). There was a significant difference in depression between the virtual reality group and the control group, the motor imagery training group and the control group at the post-test (6 weeks) and follow-up (8 weeks) (p<.05). |
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
| Sharing Statement | No |
|---|
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