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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Mixed Reality; Other: Traditional Physiotherapy

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.

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• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elena Papamichael, PhD Cand; Phone Number: 00357 99886346; Email: papamichael.e1@live.unic.ac.cy

Study Locations

• Cyprus
  • Engomi
    • Nicosia, Engomi, Cyprus, 2408
      • Recruiting
      • University of Nicosia
      • Contact: Elena Papamichael, PhD Cand; Phone Number: 00357 99886346; Email: papamichael.e1@live.unic.ac.cy
      • Principal Investigator: Elena Papamichael, PhD Cand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

For the first interventional phase:

Inclusion Criteria:

1. Male and female over 18 years old 2. Persons with independent gait 3. Normal cognitive ability 5. Greek Native language

Exclusion Criteria:

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

For the second interventional phase:

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group	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.
Experimental: Mixed Reality interventional Group	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.
Experimental: Traditional Physiotherapy Group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	baseline, 4weeks follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intrinsic Motivation Inventory	Measurement of intrinsic motivation: That contains 7 subcategories with average score from 1 to 7. Higher scores indicating better motivation	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	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	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	baseline, 4weeks follow up

Collaborators and Investigators

• Sponsor: University of Nicosia
• Investigators: Principal Investigator: Elena Papamichael, PhD Cand, University of Nicosia

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2023
• Primary Completion (Estimated): February 20, 2025
• Study Completion (Estimated): December 20, 2025

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Motivation; Physiotherapy; PD; QOL; Mixed Reality
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: ΕΕΒΚ/ΕΠ/2023/07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No