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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-100
SponsorUniversity of Nicosia

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Mixed Reality

    Other intervention

    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

    Other intervention

    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.

Treatment groups

15 Participants
are divided into 3 treatment groups
Group A: Mixed Reality interventional GroupExperimental treatment 2 interventions
Group B: Traditional Physiotherapy GroupExperimental treatment 2 interventions
Group C: Placebo groupPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
baseline, 4weeks follow up
2

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

Time frame
baseline, 4weeks follow up

Secondary outcomes

1

Intrinsic Motivation Inventory

Measurement of intrinsic motivation: That contains 7 subcategories with average score from 1 to 7. Higher scores indicating better motivation

Time frame
baseline, 4weeks follow up
2

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

Time frame
baseline, 4weeks follow up
3

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

Time frame
baseline, 4weeks follow up
4

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

Time frame
baseline, 4weeks follow up

Other outcomes

Sponsors and contacts

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