Parkinson DiseaseNCT05235880
Effects of Virtual Reality Based Games in Rehabilitation of Parkinson's Disease
A study testing Virtual reality based games and Conventional exercises in people with Parkinson Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to investigate the effects of virtual reality based games on upper extremities, trunk and cognitive functions in patients with Parkinson's Disease. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Virtual reality based games and Conventional exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2022to 15 Jun 2023
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Parkinson's disease
- 50 years old and over
- Stage 1.5-3 according to the modified Hoehn-Yahr Staging Scale
- Mini mental test score of 24 and above
Who cannot join
- Additional neurological disease or symptom other than Parkinson's disease
- Orthopedic disorder that will prevent them from doing exercises
- Severe mental disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Virtual Reality Based Games on Upper Extremities, Trunk and Cognitive Functions in Parkinson's Disease
The purpose of this study is to investigate the effects of virtual reality based games on upper extremities, trunk and cognitive functions in patients with Parkinson's Disease.
- Conditions
- Parkinson Disease
- Being tested
- Virtual reality based games, Conventional exercises
- Keywords
- parkinson disease, physiotherapy, exergames
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality based gamesOther
In an hour physiotherapy session first 40 minutes of session includes conventional physiotherapy program tailored to patient's needs. Last 20 minutes of session includes virtual reality based games aiming improvement on upper extremities, trunk and cognitive functions.
Conventional exercisesOther
In an hour physiotherapy session first 40 minutes of session includes conventional physiotherapy program tailored to patient's needs. Last 20 minutes of session includes conventional physiotherapy approaches aiming improvement on upper extremities, trunk and cognitive functions.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | 1 hour physiotherapy session for 3 times a week and 8 weeks in total. Receives: Other: Virtual reality based games |
| control group | Active comparator | 1 hour physiotherapy session for 3 times a week and 8 weeks in total. Receives: Other: Conventional exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper extremities performance with 9 hole peg test
The patient sits with a table in front of him/her and places 9 small wooden sticks on the surface with nine holes on them, takes them out again and lays them on his/her side. He/she is asked to do it as quickly as possible and his/her time is saved
Measured: Change from Baseline at 8 weeks
Upper extremities performance with Minnesota Manual Dexterity Test
It involves taking small disc-shaped objects, each of standard size, to different distances on the table in the shortest possible time and placing them in sequence, while the patient is in a sitting position with a table in front of him/her.
Measured: Change from Baseline at 8 weeks
Cognitive Status with Montreal Cognitive Assessment
its validity and reliability in Turkish have been established. The total score ranges from 0-30, and a higher score indicates a better cognitive status. Below 21 points indicates cognitive impairment.
Measured: Change from Baseline at 8 weeks
Trunk Functions with Trunk Impairment Scale
It is a valid and reliable scale for evaluating the motor disorders and balance of the trunk in Parkinson's patients. The total score in the scale, which consists of 17 items in 3 sections, ranges from 0 to 23. A higher score indicates better trunk function and balance.
Measured: Change from Baseline at 8 weeks
Secondary outcomes (4)
Dynamic balance with functional reach test
Functional reach test is frequently used to assess dynamic balance and fall risk. While the patient is standing by the wall, he/she raises his/her arm to 90 degrees and tries to reach as far as he/she can without taking his/her feet off the ground. Extending a longer distance indicates better balance and less risk of falling
Measured: Change from Baseline at 8 weeks
Balance and mobility with Timed Up and Go Test
While the patient is in a sitting position, he/she is asked to stand up from the chair, walk 3 meters, turn around, come back and sit down, and the time is recorded. Doing it in less time demonstrates better balance and mobility
Measured: Change from Baseline at 8 weeks
Quality of life with Parkinson's Disease Questionnaire
The 39-item Parkinson's Disease Questionnaire was developed to evaluate the quality of life of Parkinson's patients and has Turkish validity and reliability. Higher scores mean worse outcome.
Measured: Change from Baseline at 8 weeks
Disease severity and symptoms with Unified Parkinson Disease Rating Scale Part 2 and 3
It is one of the most frequently used scales to evaluate the severity of the disease in Parkinson's patients. It evaluates many problems such as motor and non-motor problems, treatment complications, problems in daily living activities and consists of 4 sections. However, in our study, the 2nd and 3rd sections which evaluate motor problems and activities of daily living will be used. Higher scores mean worse outcome.
Measured: Change from Baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start15 Apr 2022
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed KILINÇ, Hacettepe University
- Investigators
- Gül Yalçın Çakmaklı, Assoc. Prof., Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235880
- Sponsor's protocol ID
- KA-21067
- Status last verified
- Sep 2023
- First submitted
- 22 Dec 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalia LV, Lang AE. Parkinson's disease. Lancet. 2015 Aug 29;386(9996):896-912. doi: 10.1016/S0140-6736(14)61393-3. Epub 2015 Apr 19.
PubMed 25904081Jankovic J. Parkinson's disease: clinical features and diagnosis. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):368-76. doi: 10.1136/jnnp.2007.131045.
PubMed 18344392Abbruzzese G, Marchese R, Avanzino L, Pelosin E. Rehabilitation for Parkinson's disease: Current outlook and future challenges. Parkinsonism Relat Disord. 2016 Jan;22 Suppl 1:S60-4. doi: 10.1016/j.parkreldis.2015.09.005. Epub 2015 Sep 3.
PubMed 26360239Allen NE, Song J, Paul SS, Smith S, O'Duffy J, Schmidt M, Love R, Sherrington C, Canning CG. An interactive videogame for arm and hand exercise in people with Parkinson's disease: A randomized controlled trial. Parkinsonism Relat Disord. 2017 Aug;41:66-72. doi: 10.1016/j.parkreldis.2017.05.011. Epub 2017 May 15.
PubMed 28528804Levin MF. Can virtual reality offer enriched environments for rehabilitation? Expert Rev Neurother. 2011 Feb;11(2):153-5. doi: 10.1586/ern.10.201. No abstract available.
PubMed 21306202Cetin B, Kilinc M, Cakmakli GY. The effects of exergames on upper extremity performance, trunk mobility, gait, balance, and cognition in Parkinson's disease: a randomized controlled study. Acta Neurol Belg. 2024 Jun;124(3):853-863. doi: 10.1007/s13760-023-02451-3. Epub 2024 Jan 5.
PubMed 38182919
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality Based Games on Upper Extremities, Trunk and Cognitive Functions in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05235880
- Acronym / sponsor ID
- KA-21067
- Conditions
- Parkinson Disease
- Keywords
- parkinson disease, physiotherapy, exergames
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 11 Feb 2022 (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.
The purpose of this study is to investigate the effects of virtual reality based games on upper extremities, trunk and cognitive functions in patients with Parkinson's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: Virtual reality based games1 hour physiotherapy session for 3 times a week and 8 weeks in total. |
| control group | Active comparator | Other: Conventional exercises1 hour physiotherapy session for 3 times a week and 8 weeks in total. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with Parkinson's disease
- 50 years old and over
- Stage 1.5-3 according to the modified Hoehn-Yahr Staging Scale
- Mini mental test score of 24 and above
Key exclusion criteria (3 listed)
- Additional neurological disease or symptom other than Parkinson's disease
- Orthopedic disorder that will prevent them from doing exercises
- Severe mental disorders
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 |
|---|---|---|
| Virtual reality based gamesIn an hour physiotherapy session first 40 minutes of session includes conventional physiotherapy program tailored to patient's needs. Last 20 minutes of session includes virtual reality based games aiming improvement on upper extremities, trunk and cognitive functions. | Other | study group |
| Conventional exercisesIn an hour physiotherapy session first 40 minutes of session includes conventional physiotherapy program tailored to patient's needs. Last 20 minutes of session includes conventional physiotherapy approaches aiming improvement on upper extremities, trunk and cognitive functions. | Other | control group |
Primary outcome
Upper extremities performance with 9 hole peg test
Time frame: Change from Baseline at 8 weeks
The patient sits with a table in front of him/her and places 9 small wooden sticks on the surface with nine holes on them, takes them out again and lays them on his/her side. He/she is asked to do it as quickly as possible and his/her time is saved
Upper extremities performance with Minnesota Manual Dexterity Test
Time frame: Change from Baseline at 8 weeks
It involves taking small disc-shaped objects, each of standard size, to different distances on the table in the shortest possible time and placing them in sequence, while the patient is in a sitting position with a table in front of him/her.
Cognitive Status with Montreal Cognitive Assessment
Time frame: Change from Baseline at 8 weeks
its validity and reliability in Turkish have been established. The total score ranges from 0-30, and a higher score indicates a better cognitive status. Below 21 points indicates cognitive impairment.
Trunk Functions with Trunk Impairment Scale
Time frame: Change from Baseline at 8 weeks
It is a valid and reliable scale for evaluating the motor disorders and balance of the trunk in Parkinson's patients. The total score in the scale, which consists of 17 items in 3 sections, ranges from 0 to 23. A higher score indicates better trunk function and balance.
4 secondary outcomes
Dynamic balance with functional reach test
Time frame: Change from Baseline at 8 weeks
Balance and mobility with Timed Up and Go Test
Time frame: Change from Baseline at 8 weeks
Quality of life with Parkinson's Disease Questionnaire
Time frame: Change from Baseline at 8 weeks
Disease severity and symptoms with Unified Parkinson Disease Rating Scale Part 2 and 3
Time frame: Change from Baseline at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Background: PubMed 25904081Kalia LV, Lang AE. Parkinson's disease. Lancet. 2015 Aug 29;386(9996):896-912. doi: 10.1016/S0140-6736(14)61393-3. Epub 2015 Apr 19.
- Background: PubMed 18344392Jankovic J. Parkinson's disease: clinical features and diagnosis. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):368-76. doi: 10.1136/jnnp.2007.131045.
- Background: PubMed 26360239Abbruzzese G, Marchese R, Avanzino L, Pelosin E. Rehabilitation for Parkinson's disease: Current outlook and future challenges. Parkinsonism Relat Disord. 2016 Jan;22 Suppl 1:S60-4. doi: 10.1016/j.parkreldis.2015.09.005. Epub 2015 Sep 3.
- Background: PubMed 28528804Allen NE, Song J, Paul SS, Smith S, O'Duffy J, Schmidt M, Love R, Sherrington C, Canning CG. An interactive videogame for arm and hand exercise in people with Parkinson's disease: A randomized controlled trial. Parkinsonism Relat Disord. 2017 Aug;41:66-72. doi: 10.1016/j.parkreldis.2017.05.011. Epub 2017 May 15.
- Background: PubMed 21306202Levin MF. Can virtual reality offer enriched environments for rehabilitation? Expert Rev Neurother. 2011 Feb;11(2):153-5. doi: 10.1586/ern.10.201. No abstract available.
- Derived from this study: PubMed 38182919Cetin B, Kilinc M, Cakmakli GY. The effects of exergames on upper extremity performance, trunk mobility, gait, balance, and cognition in Parkinson's disease: a randomized controlled study. Acta Neurol Belg. 2024 Jun;124(3):853-863. doi: 10.1007/s13760-023-02451-3. Epub 2024 Jan 5.
- Individual participant dataSharing planned: No
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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.
Gül Yalçın Çakmaklı, Assoc. Prof. principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality based games and Conventional exercises in people with Parkinson Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 21 Sep 2023. 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 Turkey (Türkiye). 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper extremities performance with 9 hole peg test (time frame: Change from Baseline at 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05235880, which also lists 6 linked publications.
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 21 Sep 2023.