An interventional study of Mixed Reality and Traditional Physiotherapy in Parkinson Disease, sponsored by University of Nicosia. Recruiting at 1 site in Cyprus. Open to participants aged 60 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-14.
Sponsored by University of Nicosia · Not applicable, Interventional, and Treatment
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.
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.
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4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 15 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University of Nicosia is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For the first interventional phase:
Inclusion Criteria:
Exclusion Criteria:
For the second interventional phase:
Inclusion Criteria:
Exclusion Criteria:
Other: Mixed Reality · Other: Traditional Physiotherapy
Other: Mixed Reality · Other: Traditional Physiotherapy
Other: Mixed Reality · Other: Traditional Physiotherapy
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.
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.
EuroQol 5 Dimension 5 Level
Measurement of quality of life. Likert scoring style (1-5) where higher scores represent worse state of quality of life
Time frame: baseline, 4weeks follow up
The Short Form (12) Health Survey
Measurement of quality of life: The scores ranged from 0 to 100, where higher scores representing better quality of life
Time frame: baseline, 4weeks follow up
Intrinsic Motivation Inventory
Measurement of intrinsic motivation: That contains 7 subcategories with average score from 1 to 7. Higher scores indicating better motivation
Time frame: baseline, 4weeks follow up
Mini Balance Evaluation Systems Test
Measurement of functionality and Balance: The scale's scores ranging from 0 to 28, where higher scores represent better functionality
Time frame: baseline, 4weeks follow up
Multidirectional Reach Test
Measurement of balance and functionality: Is the only scale that includes cm for the measurement of distance. Most healthy people present 25cm. People who present less than 18cm, indicates limitations on functional balance
Time frame: baseline, 4weeks follow up
Nine-Hole Peg Test
Measurement of fine motor skills and functionality: The test scores are based on the average duration of four trials. Healthy females present 17.9-19.6 second and males 19-20.6 seconds. Higher average duration indicates limited fine mobility
Time frame: baseline, 4weeks follow up
Started Aug 2023 (actual). Primary completion is estimated for Feb 2025, 18 months after the start.
Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 18 months is below that.
Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
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