Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06356818
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-04-05
Brief Title:
Comparison of Virtual Reality and Motor Imagery Applications in Patients With Ankle Instability
Sponsor:
Istanbul University - Cerrahpasa IUC
Organization:
Istanbul University - Cerrahpasa IUC
Study Overview
Official Title:
Comparison of Virtual Reality and Motor Imagery Applications in Patients With Ankle Instability
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study the effects of different treatment methods for ankle instability patients are being compared aiming to find the optimal treatment Via comparing virtual reality motor imagery and classic rehabilitation programs to clarify their effects on ankle static and dynamic balance proprioception range of motion muscle strength pain function and patient satisfaction
Detailed Description:
This study will be carried out at Istanbul University-Cerrahpaşa Department of Physiotherapy and Rehabilitation with 30 participants Subjects who meet the inclusion criteria and who voluntarily agree to participate in this study will be randomly divided into 3 study groups as conventional physiotherapy rehabilitation treatment program Conventional virtual reality VR group and Conventional VR motor imagery MI group Group 1 Conventional physiotherapy program Physiotherapy and rehabilitation treatment program will be applied to the patients In this program a 30-40-minute exercise protocol covering proprioceptive balance and strengthening exercises will be implemented Group 2 VR group in addition to the conventional physiotherapy program virtual reality VR program will be applied to this group using balance and strengthening games by Nintendo Wii Fit Plus warm-up exercise 5 minutes workout 20 minutes and cool-down exercise 5 minutes for a total of 30 minutes Group 3 Motor imagery MI this group will be introduced to explicit Motor imagery program adding to Conventional physiotherapy and VR programs The content of the imagery program will last 20 minutes in total with 5 minutes of relaxation and 15 minutes of imagery training
All patients in the groups will be treated for a total of 12 sessions 3 days a week over a 4-week period Session duration will vary according to the groups Interventions will last approximately 40-80 minutes
Ankle mobility and instability will be assessed through different tests Balance parameters will be measured with the Star Balance Test for dynamic balance and the Single Leg Stance Test for static balance The pain intensity will be measured with the Pressure Pain Threshold device also with Visual Analog Scale Muscle strength will be assessed with a manual muscle test Ankle range of motion and joint position feeling will be measured with a mobile application such as an inclinometer Finally 2 questionnaires will be used to assess functional ability and patient satisfaction These are Cumberland ankle instability tool and Global Assessment Scale questionnaire respectively All of the assessment parameters outcomes measurement will be evaluated twice pre-treatment and post-treatment after 4 weeksWhich approximately will take from 30 to 45 minutes
GPower analysis program was used to calculate the sample size of the study While the Cumberland ankle instability tool CAIT change results were taken as reference the effect size was calculated as 135 and the number of subjects to be included in the study was reported as a total of 15 patients Group 1 5Group 2 5Group 3 5 in order to be determined as significant with 95 power and type 1 error005however the exclusion rate was added as 25 and it has been decided to include a total of 30 patients Group 1 10Group 2 10Group 3 10 1 SPSS Statistical Package for Social Sciences SPSS 200 statistical program will be used for statistical analysis of the data obtained In all analyzes p005 will be considered statistically significant Before the final analysis the data will be screened to test the normality assumption using the Shapiro-Wilk test which reflects normal distribution p 005 Furthermore Levenes test was used to test homogeneity of variance and no significant difference was found p 005 If the data are normally distributed parametric analysis eg t-Test ANOVA Paired t-Test and Linear Regression will be used otherwise non-parametric analysis eg Mann-Whitney U Test Wilcoxon Signed-Rank Test Kruskal-Wallis Test and Spearmans Rank Correlation will be used
All patients in the groups will be treated for a total of 12 sessions 3 days a week over a 4-week period Session duration will vary according to the groups Interventions will last approximately 40-80 minutes
Ankle mobility and instability will be assessed through different tests Balance parameters will be measured with the Star Balance Test for dynamic balance and the Single Leg Stance Test for static balance The pain intensity will be measured with the Pressure Pain Threshold device also with Visual Analog Scale Muscle strength will be assessed with a manual muscle test Ankle range of motion and joint position feeling will be measured with a mobile application such as an inclinometer Finally 2 questionnaires will be used to assess functional ability and patient satisfaction These are Cumberland ankle instability tool and Global Assessment Scale questionnaire respectively All of the assessment parameters outcomes measurement will be evaluated twice pre-treatment and post-treatment after 4 weeksWhich approximately will take from 30 to 45 minutes
GPower analysis program was used to calculate the sample size of the study While the Cumberland ankle instability tool CAIT change results were taken as reference the effect size was calculated as 135 and the number of subjects to be included in the study was reported as a total of 15 patients Group 1 5Group 2 5Group 3 5 in order to be determined as significant with 95 power and type 1 error005however the exclusion rate was added as 25 and it has been decided to include a total of 30 patients Group 1 10Group 2 10Group 3 10 1 SPSS Statistical Package for Social Sciences SPSS 200 statistical program will be used for statistical analysis of the data obtained In all analyzes p005 will be considered statistically significant Before the final analysis the data will be screened to test the normality assumption using the Shapiro-Wilk test which reflects normal distribution p 005 Furthermore Levenes test was used to test homogeneity of variance and no significant difference was found p 005 If the data are normally distributed parametric analysis eg t-Test ANOVA Paired t-Test and Linear Regression will be used otherwise non-parametric analysis eg Mann-Whitney U Test Wilcoxon Signed-Rank Test Kruskal-Wallis Test and Spearmans Rank Correlation will be used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None