About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Presence of neurological disease
Presence of uncontrolled diseases of the circulatory system
History of musculoskeletal surgery in the last 6 months
Use of a walking aid
Trial design
Parallel
Treatments tested in this trial
Mixed Reality
Other interventionThe 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.
Traditional Physiotherapy
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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
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
Secondary outcomes
Intrinsic Motivation Inventory
Measurement of intrinsic motivation: That contains 7 subcategories with average score from 1 to 7. Higher scores indicating better motivation
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
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
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
Sponsors and contacts
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