Clinical trial NCT06459154: The Effectiveness of Mixed Reality as Interventional Tool for the Improvement on Quality of Life for People With Parkinson´s Disease.
Official title: The Effectiveness of Mixed Reality as Interventional Tool for the Improvement on Quality of Life for People With Parkinson´s Disease. Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: PD
Mixed Reality
Physiotherapy
QOL
Motivation
Lead sponsor: University of Nicosia
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 15
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment of Randomized Control Trial
Primary purpose: TREATMENT

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.

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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Eligibility criteria: 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

Primary outcomes:
measure: EuroQol 5 Dimension 5 Level
timeFrame: baseline, 4weeks follow up
measure: The Short Form (12) Health Survey
timeFrame: baseline, 4weeks follow up
Secondary outcomes:
measure: Intrinsic Motivation Inventory
timeFrame: baseline, 4weeks follow up
measure: Mini Balance Evaluation Systems Test
timeFrame: baseline, 4weeks follow up
measure: Multidirectional Reach Test
timeFrame: baseline, 4weeks follow up
measure: Nine-Hole Peg Test
timeFrame: baseline, 4weeks follow up
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: University of Nicosia
state: Engomi
Study officials:
affiliation: University of Nicosia
name: Elena Papamichael, PhD Cand
role: PRINCIPAL_INVESTIGATOR
References: