Ignite Creation Date:
2024-07-17 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482255
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-25
Brief Title:
Evidence of the Use of Virtual Reality Versus Manual Therapy and Therapeutic Exercise in Rotator Cuff Injury
Sponsor:
University of Alcala
Organization:
University of Alcala
Study Overview
Official Title:
Evidence of the Use of Virtual Reality Versus Manual Therapy and Therapeutic Exercise in Rotator Cuff Injury
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
This study evaluates the effectiveness of virtual reality VR compared to manual therapy and therapeutic exercise in treating rotator cuff injuries It involves 108 participants divided into two groups one receiving VR combined with manual therapy and therapeutic exercise and the other receiving only manual therapy and therapeutic exercise The study spans 10 weeks with assessments at the beginning midpoint and end Variables measured include quality of life perceived pain shoulder disability strength pain intensity and shoulder mobility The aim is to determine if VR provides better outcomes in these variables compared to conventional treatments
Detailed Description:
Introduction Background The shoulder is one of the most mobile yet unstable joints in the human body making it prone to injuries like tendinopathies which are among the most disabling injuries in the upper limb Rotator cuff injuries are particularly prevalent
Rotator Cuff Comprises the supraspinatus infraspinatus subscapularis and teres minor muscles which provide stability strength and movement to the shoulder joint
Treatment Options There are conventional non-surgical and surgical treatments for rotator cuff injuries Conventional treatments are often preferred due to fewer complications and lower costs
Study Objective The study aims to assess the effectiveness of VR in comparison with traditional manual therapy and therapeutic exercise for treating rotator cuff injuries The goal is to see if integrating VR can enhance patient outcomes
Methodology Participants 108 individuals will be recruited and divided into two groups Group 1 Will receive a combination of VR manual therapy and therapeutic exercise
Group 2 Will receive only manual therapy and therapeutic exercise Duration The treatment will last for 10 weeks
Measurements The study will measure various outcomes including
Quality of Life Assessed using the SF-36 questionnaire Perceived Pain and Shoulder Disability Measured with the SPADI questionnaire Strength Evaluated using dynamometry Pain Intensity Assessed with the Numerical Rating Scale NRS Active Shoulder Mobility Measured using an inclinometer Assessment Points Measurements will be taken before treatment at the midpoint 5 weeks and at the end of the treatment 10 weeks
Data Collection and Analysis Data on pain disability strength and range of motion will be collected at three intervals pre-treatment 5 weeks and 10 weeks
Quality of life will be assessed at the beginning and end of the treatment Statistical Analysis Using SPSS version 290 descriptive and inferential statistics will be conducted to analyze the data An ANOVA will be used to study the treatment effects considering group and time as factors
Limitations Population Characteristics The specific demographic characteristics of the study population might limit the generalizability of the results
Lack of 3D Kinetic Evaluation The absence of a three-dimensional kinetic evaluation protocol for scapular dyskinesia is noted as a limitation
Cost of VR Technology The expense associated with VR technology is highlighted as a limitation since it is still a growing and costly field
Conclusion The study seeks to provide evidence on whether VR can be an effective tool alongside traditional therapies for rotator cuff injuries potentially offering new avenues for rehabilitation practices
Rotator Cuff Comprises the supraspinatus infraspinatus subscapularis and teres minor muscles which provide stability strength and movement to the shoulder joint
Treatment Options There are conventional non-surgical and surgical treatments for rotator cuff injuries Conventional treatments are often preferred due to fewer complications and lower costs
Study Objective The study aims to assess the effectiveness of VR in comparison with traditional manual therapy and therapeutic exercise for treating rotator cuff injuries The goal is to see if integrating VR can enhance patient outcomes
Methodology Participants 108 individuals will be recruited and divided into two groups Group 1 Will receive a combination of VR manual therapy and therapeutic exercise
Group 2 Will receive only manual therapy and therapeutic exercise Duration The treatment will last for 10 weeks
Measurements The study will measure various outcomes including
Quality of Life Assessed using the SF-36 questionnaire Perceived Pain and Shoulder Disability Measured with the SPADI questionnaire Strength Evaluated using dynamometry Pain Intensity Assessed with the Numerical Rating Scale NRS Active Shoulder Mobility Measured using an inclinometer Assessment Points Measurements will be taken before treatment at the midpoint 5 weeks and at the end of the treatment 10 weeks
Data Collection and Analysis Data on pain disability strength and range of motion will be collected at three intervals pre-treatment 5 weeks and 10 weeks
Quality of life will be assessed at the beginning and end of the treatment Statistical Analysis Using SPSS version 290 descriptive and inferential statistics will be conducted to analyze the data An ANOVA will be used to study the treatment effects considering group and time as factors
Limitations Population Characteristics The specific demographic characteristics of the study population might limit the generalizability of the results
Lack of 3D Kinetic Evaluation The absence of a three-dimensional kinetic evaluation protocol for scapular dyskinesia is noted as a limitation
Cost of VR Technology The expense associated with VR technology is highlighted as a limitation since it is still a growing and costly field
Conclusion The study seeks to provide evidence on whether VR can be an effective tool alongside traditional therapies for rotator cuff injuries potentially offering new avenues for rehabilitation practices
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