NCT06459154

The Effectiveness of Mixed Reality as Interventional Tool for the Improvement on Quality of Life for People With Parkinson´s Disease.

The Effectiveness of Mixed Reality as Interventional Tool for the Improvement on Quality of Life for People With Parkinson´s Disease. Randomized Control Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: University of Nicosia · Academic / Other
• Sex: All
• Age: 60 Years – 100 Years
• Healthy volunteers: Accepted

Summary

Parkinson's 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 Parkinson's 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 Parkinson's disease.

Detailed description

Parkinson's 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 Parkinson's 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 Parkinson's 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 Parkinson's 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 DeepL.com (free version)

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
OTHER	Mixed Reality	The experimental group MR will use the mixed reality project involving activities in a supermarket. MR HoloLens2 glasses will be used to conduct the program. The technological equipment that will be used will allow the provision of visual and auditory stimuli. The program presents 5-10 different objects found in a supermarket, where you need, as you walk, to collect them within a mixed environment. This program offers coordination activities, posture, cognitive activities and balance exercises. The mixed reality program lasts 30 minutes, with a frequency of 3 times a week for 12 weeks.
OTHER	Traditional Physiotherapy	The group of traditional physiotherapy follows the guidelines of EPDA. Specifically, the program will be 35-40 minutes long, 3 times a week for 12 weeks. The program includes 5 minutes warm up, 10 minutes resistance exercises, 10 minutes of balance exercises and stretching.

Timeline

• Start date: 2023-08-20
• Primary completion: 2025-02-20
• Completion: 2025-12-20
• First posted: 2024-06-14
• Last updated: 2024-06-14

Locations

1 site across 1 country: Cyprus