Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06362785
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-03-26
Brief Title:
Musculoskeletal Pain Motor Control Risk of Falls and Virtual Reality
Sponsor:
Universidade da Coruña
Organization:
Universidade da Coruña
Study Overview
Official Title:
Study on the Relationship Between Musculoskeletal Pain Motor Control and the Risk of Falls and the Effectiveness of Virtual Reality in Managing it in Older People
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
The goal of this clinical trial is to learn about musculoskeletal pain functionality and risk of falls in community-dwelling adults aged 60 years and older The main questions it aims to answer are
What are the characteristics of a community-dwelling population over 60 years and older in terms of musculoskeletal pain functionality and risk of falls
Does an intervention with virtual reality lower musculoskeletal pain raise functionality and prevent falls in community-dwelling adults aged 60 years and older compared to a control group that does not receive such intervention
Participants will
Answer questionnaires
Perform physical laboratory tests through a camera-based motion capture system
Execute task-based exercises in a virtual environment through virtual reality
Researchers will compare community-dwelling adults aged 60 years and older who execute task based exercises in a virtual environment through virtual reality and community-dwelling adults aged 60 years and older without any intervention to see if virtual reality improves musculoskeletal pain functionality and lowers fall risk
What are the characteristics of a community-dwelling population over 60 years and older in terms of musculoskeletal pain functionality and risk of falls
Does an intervention with virtual reality lower musculoskeletal pain raise functionality and prevent falls in community-dwelling adults aged 60 years and older compared to a control group that does not receive such intervention
Participants will
Answer questionnaires
Perform physical laboratory tests through a camera-based motion capture system
Execute task-based exercises in a virtual environment through virtual reality
Researchers will compare community-dwelling adults aged 60 years and older who execute task based exercises in a virtual environment through virtual reality and community-dwelling adults aged 60 years and older without any intervention to see if virtual reality improves musculoskeletal pain functionality and lowers fall risk
Detailed Description:
Background
Musculoskeletal pain MSP is common among older adults affecting a considerable proportion of this population and being associated with various conditions such as joint pain muscle pain or back pain among others More specifically neck pain and low back pain are highly painful and disabling globally entailing a significant cost both economically and in terms of healthcare
Several studies have demonstrated a strong association between MSP and falls in older adults In particular it was observed that MSP is a significant predictor of multiple falls and is closely related to a balance deficit
To properly understand the close relationship between MSP and falls it is crucial to consider dysfunctions in motor control associated with pain as they are often the main trigger for falls Studies in this field highlight the importance of directing new research with a focus on functional tasks as they represent the epitome of motor control Therefore the observation and analysis of functional tasks are crucial for examining the motor control of older adults being 3D motion capture systems the gold standard for the measurement and analysis of human movement On the other hand new technologies such as immersive virtual reality VR are gaining recognition and popularity as treatment modalities This is because they allow users to interact with environments and situations that simulate real life offering activities tailored to their needs while avoiding the potential risks of the real world Additionally it provides an opportunity to repeat exercises improve performance and achieve effective learning
Objectives Several objectives are outlined as a comprehensive approach involving two different phases will be carried out
Phase 1 Cross-Sectional Study Main objective to describe the population aged 60 and older living in the community in terms of musculoskeletal pain functionality and fall risk
Phase 2 Experimental Study Main objective to assess the efficacy of a virtual reality intervention in a community-dwelling population aged 60 and above in terms of musculoskeletal pain reduction functionality improvement and fall risk reduction
Methods
Setting locations and relevant dates testing is going to be conducted in the Research Center for Information and Communication Technologies CITIC A Coruña Spain and Senior University Center of the University of A Coruña A Coruña Spain
Data collection is planned for the months of May 2024 to May 2025
Participants the recruitment of participants will be carried out through the dissemination of the study via informative posters distributed in the University of A Coruña including the Senior University in the network of civic centers in the city of A Coruña as well as electronically through the researchers social media networks Twitter Facebook and Instagram The participant information process as well as the request for informed consent will be conducted in the CITIC after having answered the pre-selection questionnaires
Variables see outcomes measures
Study size the sample size is estimated using the G-power program indicating that the minimum number of participants needed to detect medium effect sizes with a type I error probability of 005 and a power of 095 with an effect size of 07 and considering the analysis through the t-test the difference between two independent means would be a total of 110 participants
Statistical analysis a descriptive analysis will be performed to characterize the subjects in detail Qualitative variables will be presented as absolute figures with their respective percentages and quantitative variables as measures of central tendency mean and median and dispersion standard deviation minimum and maximum values The Kolmogorov-Smirnov test will be used to assess the normality of data distribution
To explore significant differences between groups a bivariate statistical analysis will be conducted The Students T-test for independent samples will be used for comparing means if the variables under consideration are normal otherwise the Mann-Whitney U test will be employed for non-normal variables The chi-square statistic X2 with a 95 confidence interval will be applied for the association of qualitative variables The correlation between quantitative variables will be assessed using the Pearson or Spearman correlation coefficient A significance level of p 005 will be considered Data processing and analysis will be carried out using the statistical package SPSS version 240 for Windows Armonk NY IBM Corp
Musculoskeletal pain MSP is common among older adults affecting a considerable proportion of this population and being associated with various conditions such as joint pain muscle pain or back pain among others More specifically neck pain and low back pain are highly painful and disabling globally entailing a significant cost both economically and in terms of healthcare
Several studies have demonstrated a strong association between MSP and falls in older adults In particular it was observed that MSP is a significant predictor of multiple falls and is closely related to a balance deficit
To properly understand the close relationship between MSP and falls it is crucial to consider dysfunctions in motor control associated with pain as they are often the main trigger for falls Studies in this field highlight the importance of directing new research with a focus on functional tasks as they represent the epitome of motor control Therefore the observation and analysis of functional tasks are crucial for examining the motor control of older adults being 3D motion capture systems the gold standard for the measurement and analysis of human movement On the other hand new technologies such as immersive virtual reality VR are gaining recognition and popularity as treatment modalities This is because they allow users to interact with environments and situations that simulate real life offering activities tailored to their needs while avoiding the potential risks of the real world Additionally it provides an opportunity to repeat exercises improve performance and achieve effective learning
Objectives Several objectives are outlined as a comprehensive approach involving two different phases will be carried out
Phase 1 Cross-Sectional Study Main objective to describe the population aged 60 and older living in the community in terms of musculoskeletal pain functionality and fall risk
Phase 2 Experimental Study Main objective to assess the efficacy of a virtual reality intervention in a community-dwelling population aged 60 and above in terms of musculoskeletal pain reduction functionality improvement and fall risk reduction
Methods
Setting locations and relevant dates testing is going to be conducted in the Research Center for Information and Communication Technologies CITIC A Coruña Spain and Senior University Center of the University of A Coruña A Coruña Spain
Data collection is planned for the months of May 2024 to May 2025
Participants the recruitment of participants will be carried out through the dissemination of the study via informative posters distributed in the University of A Coruña including the Senior University in the network of civic centers in the city of A Coruña as well as electronically through the researchers social media networks Twitter Facebook and Instagram The participant information process as well as the request for informed consent will be conducted in the CITIC after having answered the pre-selection questionnaires
Variables see outcomes measures
Study size the sample size is estimated using the G-power program indicating that the minimum number of participants needed to detect medium effect sizes with a type I error probability of 005 and a power of 095 with an effect size of 07 and considering the analysis through the t-test the difference between two independent means would be a total of 110 participants
Statistical analysis a descriptive analysis will be performed to characterize the subjects in detail Qualitative variables will be presented as absolute figures with their respective percentages and quantitative variables as measures of central tendency mean and median and dispersion standard deviation minimum and maximum values The Kolmogorov-Smirnov test will be used to assess the normality of data distribution
To explore significant differences between groups a bivariate statistical analysis will be conducted The Students T-test for independent samples will be used for comparing means if the variables under consideration are normal otherwise the Mann-Whitney U test will be employed for non-normal variables The chi-square statistic X2 with a 95 confidence interval will be applied for the association of qualitative variables The correlation between quantitative variables will be assessed using the Pearson or Spearman correlation coefficient A significance level of p 005 will be considered Data processing and analysis will be carried out using the statistical package SPSS version 240 for Windows Armonk NY IBM Corp
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