The Effectiveness of Mixed Reality as Interventional Tool for the Improvement on Quality of Life for People With Parkinson´s Disease.
NCT ID: NCT06459154
Last Updated: 2024-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2023-08-20
2025-12-20
Brief Summary
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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.
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Detailed Description
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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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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mixed Reality interventional Group
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.
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.
Traditional Physiotherapy Group
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.
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.
Placebo group
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
1. Male and female over 60 years old
2. Persons with independent gait
3. Normal cognitive ability
5\. Greek Native language
Exclusion Criteria
2. Presence of uncontrolled diseases of the circulatory system
3. History of musculoskeletal surgery in the last 6 months
4. Use of a walking aid
5. Partial or total blindness
For the second interventional phase:
1. Presence of neurological disease
2. Presence of uncontrolled diseases of the circulatory system
3. History of musculoskeletal surgery in the last 6 months
4. Use of a walking aid
5. Partial or total blindness
60 Years
100 Years
ALL
Yes
Sponsors
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University of Nicosia
OTHER
Responsible Party
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Elena Papamichael
PhD Candidate in Physiotherapy
Principal Investigators
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Elena Papamichael, PhD Cand
Role: PRINCIPAL_INVESTIGATOR
University of Nicosia
Locations
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University of Nicosia
Nicosia, Engomi, Cyprus
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ΕΕΒΚ/ΕΠ/2023/07
Identifier Type: -
Identifier Source: org_study_id
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