RecruitingNot ApplicableNCT06459154

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

Sponsor

University of Nicosia

Enrollment

15 participants

Start Date

Aug 20, 2023

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease

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.

Eligibility

Min Age: 60 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether mixed reality (MR) technology — a blend of real and virtual environments experienced through a headset — can improve balance, movement, and quality of life in people with Parkinson's disease. **You may be eligible if (Phase 1 — healthy volunteers)...** - You are over 18 years old - You can walk independently without a walking aid - You have normal cognitive ability - Greek is your native language **You may be eligible if (Phase 2 — Parkinson's patients)...** - You have been diagnosed with Parkinson's disease - You meet similar functional criteria as Phase 1 **You may NOT be eligible if...** - You have a neurological disease (Phase 1) or uncontrolled neurological/cardiovascular conditions - You use a walking aid - You have had musculoskeletal surgery in the past 6 months - You have partial or complete blindness Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERMixed 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.

OTHERTraditional 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.