The Effectiveness of Mixed Reality as Interventional Tool for the Improvement on Quality of Life for People With Parkinson´s Disease.

NCT06459154 | Recruiting

• 1 other identifier: ΕΕΒΚ/ΕΠ/2023/07
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

PD; Mixed Reality; Physiotherapy; QOL; Motivation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Intrinsic Motivation Inventory

  baseline, 4weeks follow up

• Mini Balance Evaluation Systems Test

  baseline, 4weeks follow up

• Multidirectional Reach Test

  baseline, 4weeks follow up

• Nine-Hole Peg Test

  baseline, 4weeks follow up

Study Arms (3)

Mixed Reality interventional Group

EXPERIMENTAL

Other: Mixed Reality; Other: Traditional Physiotherapy

Traditional Physiotherapy Group

EXPERIMENTAL

Other: Mixed Reality; Other: Traditional Physiotherapy

Placebo group

PLACEBO COMPARATOR

Other: Mixed Reality; Other: Traditional Physiotherapy

Interventions

Mixed Reality OTHER

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.

Mixed Reality interventional Group; Placebo group; Traditional Physiotherapy Group

Traditional Physiotherapy OTHER

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.

Mixed Reality interventional Group; Placebo group; Traditional Physiotherapy Group

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Partial or total blindness
• For the second interventional phase:
• Male and female over 60 years old
• Persons with independent gait
• Normal cognitive ability
• \. Greek Native language
• 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
• Partial or total blindness

Sponsors & Collaborators

• University of Nicosia: lead

Study Sites (1)

University of Nicosia

Nicosia, Engomi, 2408, Cyprus

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Elena Papamichael, PhD Cand

  University of Nicosia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Papamichael, PhD Cand

CONTACT

99886346; papamichael.e1@live.unic.ac.cy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate in Physiotherapy

Model Details: Parallel assignment of Randomized Control Trial

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: June 14, 2024
• Study Start: August 20, 2023
• Primary Completion: February 20, 2025
• Study Completion: December 20, 2025
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

CY (1)