Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06459154
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-05-15
Brief Title:
The Effectiveness of Mixed Reality as Interventional Tool for the Improvement on Quality of Life for People With Parkinsons Disease
Sponsor:
University of Nicosia
Organization:
University of Nicosia
Study Overview
Official Title:
The Effectiveness of Mixed Reality as Interventional Tool for the Improvement on Quality of Life for People With Parkinsons Disease Randomized Control Trial
Status:
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:
Parkinsons disease is a chronic neurodegenerative disease of unknown cause affecting elderly people over the age of 60 It is the second most common neurodegenerative disease presenting psychomotor signs and symptoms that lead to impaired functionality and quality of life in affected individuals Mixed reality involves the delivery of digital stimuli in real time and space through spatial mapping using glasses safely providing multiple iterations to carry out daily activities
Through this tool and in collaboration with technologically skilled mixed reality developers the software for the rehabilitation program to be applied to Parkinsons disease patients was also developed
The main objective of this clinical study is to examine the effect of a mixed reality program compared to a traditional physiotherapy program on quality of life and motivation for the participation of people with Parkinsons disease
Through this tool and in collaboration with technologically skilled mixed reality developers the software for the rehabilitation program to be applied to Parkinsons disease patients was also developed
The main objective of this clinical study is to examine the effect of a mixed reality program compared to a traditional physiotherapy program on quality of life and motivation for the participation of people with Parkinsons disease
Detailed Description:
Parkinsons disease is a chronic neurodegenerative disease of unknown cause affecting elderly people over the age of 60 It is the second most common neurodegenerative disease presenting psychomotor signs and symptoms that lead to impaired functioning and quality of life in affected individuals Mixed reality involves the delivery of digital stimuli in real time and space through spatial mapping using glasses safely providing multiple iterations to carry out daily activities
Through this tool and in collaboration with technologically skilled mixed reality developers the software for the rehabilitation program to be applied to Parkinsons disease patients was also developed
The main objective of this clinical study is to examine the effect of a mixed reality program compared to a traditional physiotherapy program on quality of life and motivation for the participation for people with Parkinsons disease
The study will be divided into two phases the first of which includes the translation and adaptation of the Intrinsic Motivation Inventory IMI questionnaire which assesses motivation and is not available in Greek and will be used in 300 healthy subjects to assess its psychometric characteristics
The second phase of the clinical trial is a parallel blinded randomized study involving 45 patients
This study will provide the opportunity to use innovative equipment that offers multiple stimuli increasing the interactivity of the participants to perform functional activities This research is the first clinical study in Cyprus that will apply the reported rehabilitation tool aiming to improve and evaluate the quality of life functionality and motivation of people with Parkinsons disease Moreover it enables the development of cognitive and motor rehabilitation by increasing the interaction of the individual with the environment and facilitating the completion of treatment goals
The research using mixed reality and through a comparative process with traditional physiotherapy aims to provide valid and reliable data to the general public and health scientists facilitating the selection of appropriate means to provide a holistic treatment plan
Translated with DeepLcom free version
Through this tool and in collaboration with technologically skilled mixed reality developers the software for the rehabilitation program to be applied to Parkinsons disease patients was also developed
The main objective of this clinical study is to examine the effect of a mixed reality program compared to a traditional physiotherapy program on quality of life and motivation for the participation for people with Parkinsons disease
The study will be divided into two phases the first of which includes the translation and adaptation of the Intrinsic Motivation Inventory IMI questionnaire which assesses motivation and is not available in Greek and will be used in 300 healthy subjects to assess its psychometric characteristics
The second phase of the clinical trial is a parallel blinded randomized study involving 45 patients
This study will provide the opportunity to use innovative equipment that offers multiple stimuli increasing the interactivity of the participants to perform functional activities This research is the first clinical study in Cyprus that will apply the reported rehabilitation tool aiming to improve and evaluate the quality of life functionality and motivation of people with Parkinsons disease Moreover it enables the development of cognitive and motor rehabilitation by increasing the interaction of the individual with the environment and facilitating the completion of treatment goals
The research using mixed reality and through a comparative process with traditional physiotherapy aims to provide valid and reliable data to the general public and health scientists facilitating the selection of appropriate means to provide a holistic treatment plan
Translated with DeepLcom free version
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