Mild Cognitive Impairment (MCI)NCT07005271
VR Hand Exercises: Impact on Cognition and Dexterity in MCI
A study testing virtual reality and Conventional treatment in people with Mild Cognitive Impairment (MCI), run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effects of virtual reality (VR)-based hand exercises on cognitive functions and hand skills in older adults with mild cognitive impairment (MCI). Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- virtual reality and Conventional treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Oct 2025to 26 Feb 2026
- 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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged between 65 and 75 years.
- Diagnosed with mild cognitive impairment by the institution's physician during routine examination.
- Ability to understand and follow verbal instructions.
Who cannot join
- Presence of neurodegenerative diseases affecting cognitive functions.
- Auditory or visual impairments that could interfere with rehabilitation implementation and communication.
- Upper extremity disorders, including severe shoulder, elbow, wrist, or finger impairments, bilateral elbow, hand or wrist fractures, or advanced rheumatoid arthritis.
- Participation in any rehabilitation program during the study period.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Metropolitan Municipality Darülaceze Directorate
Istanbul, Ataşehir, 34755
About this study
Official title: Investigation of the Effects of Virtual Reality-Based Hand Exercises on Cognitive Function and Hand Dexterity in Older Adults With Mild Cognitive Impairment.
This study aims to investigate the effects of virtual reality (VR)-based hand exercises on cognitive functions and hand skills in older adults with mild cognitive impairment (MCI). Cognitive functions will be assessed by measuring brain activity using functional near-infrared spectroscopy (fNIRS) during the Stroop test. Additionally, hand functions will be evaluated using the Minnesota Manual Dexterity Test, grip strength measurement (via a Jamar dynamometer), and the Duruöz Hand Index. Hand dominance will be determined using the Edinburgh Handedness Inventory, and sociodemographic data will be collected through a form prepared by the researcher. Based on a G*Power analysis, a total of 30 participants-15 in each group-will be included in the study, with an effect size of 1.00094 and a power of 80%. Evaluations will be conducted twice, before and after the intervention. To avoid participant fatigue, assessments will be divided over two days. The intervention group will receive VR-based hand exercises twice a week for six weeks. These exercises will include activities such as MasterChef (cutting, mixing, and grasping in a virtual kitchen), PinchPeg (placing pegs using pinch grip), HoldAndPut (transporting cups or cans), and bPuzzle (color matching and puzzle completion). The control group will perform traditional exercises twice a week for six weeks, including 30-50 piece puzzle completion, the Nine-Hole Peg Test, shape cutting, and number-color matching tasks. The study will be conducted with volunteer participants at the Istanbul Metropolitan Municipality Darülaceze Directorate, and written and verbal informed consent will be obtained from all participants in accordance with the principles of the Declaration of Helsinki.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- virtual reality, Conventional treatment
- Keywords
- virtual reality, hand exercise, mild cognitive impairment, cortical activation, hand dextery
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityBehavioural
The exercises in this group consist of four different games, including: (1) MasterChef, which involves performing daily living tasks in a virtual kitchen environment such as slicing tomatoes and cheese, adding salt, cracking and adding eggs, and stirring with a fork to prepare an omelet; (2) PinchPeg, where participants use a pinch grip to grasp rods generated in the center of a virtual environment and place them into holes on a pegboard, followed by removing and returning them to their original location; (3) Hold and Put, which requires the use of a standard palmar grasp to pick up virtual cups or cans and place them onto designated shelves; and (4) bPuzzle, a task that integrates cognitive and fine motor exercises by requiring participants to change the color of a puzzle using finger movements and place the pieces into the correct positions using hand gestures.
Conventional treatmentBehavioural
Participants will be asked to complete puzzles consisting of 30 to 50 pieces, with 3 to 4 different puzzles used to eliminate the learning effect. They will perform the Nine-Hole Peg Test, which is similar to the PinchPeg game in the virtual reality group, by picking up pegs one by one from a container and placing them into holes on the board as quickly as possible using only the evaluated hand; this will be used for training purposes. Additionally, participants will be instructed to cut out geometric shapes with dotted outlines using scissors, aiming to follow the lines accurately. Finally, they will sort objects by placing the correct number and color of items into designated locations according to a predetermined pattern, and use a magnetic fishing rod to catch wooden fish, promoting both fine motor skills and task-oriented hand function.
| Study group | Role | What they receive |
|---|---|---|
| virtual reality | Experimental | Participants in this group will perform hand exercises using virtual reality. They will complete task-oriented hand exercises resembling activities of daily living through the ErgoActive system, which consists of four different games. Receives: Behavioral: virtual reality |
| Conventional treatment | Active comparator | Participants in this group will perform exercises involving hand skills used in daily life. These exercises will be similar to those in the virtual reality group but will be carried out in their real-life form. Receives: Behavioral: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical Hemodynamics (Functional Near-Infrared Spectroscopy)
Measured: before treatment, week 6
Hand skills (Minnesota Manual Dexterity Test)
Measured: before treatment, week 6
Activities of daily living (Duruöz Hand Index)
Measured: before treatment, week 6
Secondary outcomes (2)
Gross grip strength (Jamar hand dynamometer)
Measured: before treatment, week 6
Determination of hand preference (Edinburgh Handedness Inventory)
Measured: before treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start16 Oct 2025
- Primary completion25 Jan 2026
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- More trials run by Istinye 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berrak Varhan, Study chair, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005271
- Sponsor's protocol ID
- 24-326
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study will share de-identified, summary-level outcome data, including group-level means, standard deviations, effect sizes, and p-values derived from statistical analyses. These data will be provided to support transparency and allow for interpretation of the study findings.
Publications
Park JH. Effects of Cognitive-Physical Dual-Task Training on Executive Function and Activity in the Prefrontal Cortex of Older Adults with Mild Cognitive Impairment. Brain Neurorehabil. 2021 Sep 13;14(3):e23. doi: 10.12786/bn.2021.14.e23. eCollection 2021 Nov.
PubMed 36741221Liao YY, Tseng HY, Lin YJ, Wang CJ, Hsu WC. Using virtual reality-based training to improve cognitive function, instrumental activities of daily living and neural efficiency in older adults with mild cognitive impairment. Eur J Phys Rehabil Med. 2020 Feb;56(1):47-57. doi: 10.23736/S1973-9087.19.05899-4. Epub 2019 Oct 15.
PubMed 31615196
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Virtual Reality-Based Hand Exercises on Cognitive Function and Hand Dexterity in Older Adults With Mild Cognitive Impairment.
- ClinicalTrials.gov ID
- NCT07005271
- Acronym / sponsor ID
- 24-326
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- virtual reality, hand exercise, mild cognitive impairment, cortical activation, hand dextery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- 25 Jan 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 5 Jun 2025 (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.
This study aims to investigate the effects of virtual reality (VR)-based hand exercises on cognitive functions and hand skills in older adults with mild cognitive impairment (MCI). Cognitive functions will be assessed by measuring brain activity using functional near-infrared spectroscopy (fNIRS) during the Stroop test. Additionally, hand functions will be evaluated using the Minnesota Manual Dexterity Test, grip strength measurement (via a Jamar dynamometer), and the Duruöz Hand Index. Hand dominance will be determined using the Edinburgh Handedness Inventory, and sociodemographic data will be collected through a form prepared by the researcher. Based on a G*Power analysis, a total of 30 participants-15 in each group-will be included in the study, with an effect size of 1.00094 and a power of 80%. Evaluations will be conducted twice, before and after the intervention. To avoid participant fatigue, assessments will be divided over two days. The intervention group will receive VR-based hand exercises twice a week for six weeks. These exercises will include activities such as MasterChef (cutting, mixing, and grasping in a virtual kitchen), PinchPeg (placing pegs using pinch grip), HoldAndPut (transporting cups or cans), and bPuzzle (color matching and puzzle completion). The control group will perform traditional exercises twice a week for six weeks, including 30-50 piece puzzle completion, the Nine-Hole Peg Test, shape cutting, and number-color matching tasks. The study will be conducted with volunteer participants at the Istanbul Metropolitan Municipality Darülaceze Directorate, and written and verbal informed consent will be obtained from all participants in accordance with the principles of the Declaration of Helsinki.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality | Experimental | Behavioral: virtual realityParticipants in this group will perform hand exercises using virtual reality. They will complete task-oriented hand exercises resembling activities of daily living through the ErgoActive system, which consists of four different games. |
| Conventional treatment | Active comparator | Behavioral: Conventional treatmentParticipants in this group will perform exercises involving hand skills used in daily life. These exercises will be similar to those in the virtual reality group but will be carried out in their real-life form. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Aged between 65 and 75 years.
- Diagnosed with mild cognitive impairment by the institution's physician during routine examination.
- Ability to understand and follow verbal instructions.
Key exclusion criteria (4 listed)
- Presence of neurodegenerative diseases affecting cognitive functions.
- Auditory or visual impairments that could interfere with rehabilitation implementation and communication.
- Upper extremity disorders, including severe shoulder, elbow, wrist, or finger impairments, bilateral elbow, hand or wrist fractures, or advanced rheumatoid arthritis.
- Participation in any rehabilitation program during the study period.
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 realityThe exercises in this group consist of four different games, including: (1) MasterChef, which involves performing daily living tasks in a virtual kitchen environment such as slicing tomatoes and cheese, adding salt, cracking and adding eggs, and stirring with a fork to prepare an omelet; (2) PinchPeg, where participants use a pinch grip to grasp rods generated in the center of a virtual environment and place them into holes on a pegboard, followed by removing and returning them to their original location; (3) Hold and Put, which requires the use of a standard palmar grasp to pick up virtual cups or cans and place them onto designated shelves; and (4) bPuzzle, a task that integrates cognitive and fine motor exercises by requiring participants to change the color of a puzzle using finger movements and place the pieces into the correct positions using hand gestures. | Behavioural | virtual reality |
| Conventional treatmentParticipants will be asked to complete puzzles consisting of 30 to 50 pieces, with 3 to 4 different puzzles used to eliminate the learning effect. They will perform the Nine-Hole Peg Test, which is similar to the PinchPeg game in the virtual reality group, by picking up pegs one by one from a container and placing them into holes on the board as quickly as possible using only the evaluated hand; this will be used for training purposes. Additionally, participants will be instructed to cut out geometric shapes with dotted outlines using scissors, aiming to follow the lines accurately. Finally, they will sort objects by placing the correct number and color of items into designated locations according to a predetermined pattern, and use a magnetic fishing rod to catch wooden fish, promoting both fine motor skills and task-oriented hand function. | Behavioural | Conventional treatment |
Primary outcome
Cortical Hemodynamics (Functional Near-Infrared Spectroscopy)
Time frame: before treatment, week 6
Hand skills (Minnesota Manual Dexterity Test)
Time frame: before treatment, week 6
Activities of daily living (Duruöz Hand Index)
Time frame: before treatment, week 6
2 secondary outcomes
Gross grip strength (Jamar hand dynamometer)
Time frame: before treatment, week 6
Determination of hand preference (Edinburgh Handedness Inventory)
Time frame: before treatment
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 13 Apr 2026.
- Background: PubMed 36741221Park JH. Effects of Cognitive-Physical Dual-Task Training on Executive Function and Activity in the Prefrontal Cortex of Older Adults with Mild Cognitive Impairment. Brain Neurorehabil. 2021 Sep 13;14(3):e23. doi: 10.12786/bn.2021.14.e23. eCollection 2021 Nov.
- Background: PubMed 31615196Liao YY, Tseng HY, Lin YJ, Wang CJ, Hsu WC. Using virtual reality-based training to improve cognitive function, instrumental activities of daily living and neural efficiency in older adults with mild cognitive impairment. Eur J Phys Rehabil Med. 2020 Feb;56(1):47-57. doi: 10.23736/S1973-9087.19.05899-4. Epub 2019 Oct 15.
- Individual participant dataSharing planned: Yes. The study will share de-identified, summary-level outcome data, including group-level means, standard deviations, effect sizes, and p-values derived from statistical analyses. These data will be provided to support transparency and allow for interpretation of the study findings.
Related trials for Mild Cognitive Impairment (MCI)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
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.
Berrak Varhan study chair
Istinye 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 and Conventional treatment in people with Mild Cognitive Impairment (MCI), run by Istinye 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 3 inclusion and 4 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 13 Apr 2026. 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?
Cortical Hemodynamics (Functional Near-Infrared Spectroscopy) (time frame: before treatment, week 6). The study lists 3 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 NCT07005271, which also lists 2 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 13 Apr 2026.