Parkinson DiseaseNCT06459154
The Effectiveness of Mixed Reality as Interventional Tool for the Improvement on Quality of Life for People With Parkinson´s Disease.
A study testing Mixed Reality and Traditional Physiotherapy in people with Parkinson Disease, run by University of Nicosia at 1 site in Cyprus.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Mixed Reality and Traditional Physiotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCyprus
- Study dates
- 20 Aug 2023to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Male and female over 18 years old 2. Persons with independent gait 3. Normal cognitive ability 5. Greek Native language
- Male and female over 60 years old
- Persons with independent gait
- Normal cognitive ability
- 5. Greek Native language
Who cannot join
- 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:
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Cyprus1 site, 1 recruiting
- Recruiting
University of Nicosia
Nicosia, Engomi, 2408
Elena Papamichael, PhD Cand, 99886346 ext. 00357, papamichael.e1@live.unic.ac.cy
Elena Papamichael, PhD Cand
About this study
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
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.
Read the 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.
Translated with DeepL.com (free version)
- Conditions
- Parkinson Disease
- Being tested
- Mixed Reality, Traditional Physiotherapy
- Keywords
- PD, Mixed Reality, Physiotherapy, QOL, Motivation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed RealityOther
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 PhysiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mixed Reality interventional Group | Experimental | Not described Receives: Other: Mixed Reality; Other: Traditional Physiotherapy |
| Traditional Physiotherapy Group | Experimental | Not described Receives: Other: Mixed Reality; Other: Traditional Physiotherapy |
| Placebo group | Placebo comparator | Not described Receives: Other: Mixed Reality; Other: Traditional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: baseline, 4weeks follow up
Secondary outcomes (4)
Intrinsic Motivation Inventory
Measurement of intrinsic motivation: That contains 7 subcategories with average score from 1 to 7. Higher scores indicating better motivation
Measured: 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
Measured: 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
Measured: 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
Measured: baseline, 4weeks follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start20 Aug 2023
- Primary completion20 Feb 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment of Randomized Control Trial
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nicosia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Papamichael, University of Nicosia
- Investigators
- Elena Papamichael, PhD Cand, Principal investigator, University of Nicosia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459154
- Sponsor's protocol ID
- ΕΕΒΚ/ΕΠ/2023/07
- Status last verified
- Jun 2024
- First submitted
- 15 May 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06459154
- Acronym / sponsor ID
- ΕΕΒΚ/ΕΠ/2023/07
- Conditions
- Parkinson Disease
- Keywords
- PD, Mixed Reality, Physiotherapy, QOL, Motivation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of NicosiaUniversity, hospital or other
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- 20 Feb 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Translated with DeepL.com (free version)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel assignment of Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Male and female over 18 years old 2. Persons with independent gait 3. Normal cognitive ability 5. Greek Native language
- Male and female over 60 years old
- Persons with independent gait
- Normal cognitive ability
- 5. Greek Native language
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixed RealityThe 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 | Mixed Reality interventional Group, Placebo group, Traditional Physiotherapy Group |
| Traditional PhysiotherapyThe 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. | Other | Mixed Reality interventional Group, Placebo group, Traditional Physiotherapy Group |
Primary outcome
EuroQol 5 Dimension 5 Level
Time frame: baseline, 4weeks follow up
Measurement of quality of life. Likert scoring style (1-5) where higher scores represent worse state of quality of life
The Short Form (12) Health Survey
Time frame: baseline, 4weeks follow up
Measurement of quality of life: The scores ranged from 0 to 100, where higher scores representing better quality of life
4 secondary outcomes
Intrinsic Motivation Inventory
Time frame: baseline, 4weeks follow up
Mini Balance Evaluation Systems Test
Time frame: baseline, 4weeks follow up
Multidirectional Reach Test
Time frame: baseline, 4weeks follow up
Nine-Hole Peg Test
Time frame: baseline, 4weeks follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Papamichael, PhD Cand principal investigator
University of Nicosia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed Reality and Traditional Physiotherapy in people with Parkinson Disease, run by University of Nicosia at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Papamichael, PhD Cand (99886346 ext. 00357, papamichael.e1@live.unic.ac.cy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EuroQol 5 Dimension 5 Level (time frame: baseline, 4weeks follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.