NCT07005271

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

October 16, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2026

Completed
Last Updated

April 13, 2026

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

June 3, 2025

Last Update Submit

April 8, 2026

Conditions

Keywords

virtual realityhand exercisemild cognitive impairmentcortical activationhand dextery

Outcome Measures

Primary Outcomes (3)

  • Cortical Hemodynamics (Functional Near-Infrared Spectroscopy)

    before treatment, week 6

  • Hand skills (Minnesota Manual Dexterity Test)

    before treatment, week 6

  • Activities of daily living (Duruöz Hand Index)

    before treatment, week 6

Secondary Outcomes (2)

  • Gross grip strength (Jamar hand dynamometer)

    before treatment, week 6

  • Determination of hand preference (Edinburgh Handedness Inventory)

    before treatment

Study Arms (2)

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.

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.

Behavioral: Conventional treatment

Interventions

virtual realityBEHAVIORAL

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.

virtual reality

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.

Conventional treatment

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Metropolitan Municipality Darülaceze Directorate

Istanbul, Ataşehir, 34755, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 36741221BACKGROUND
  • Liao 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.

    PMID: 31615196BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Berrak Varhan

    Istinye University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2025

First Posted

June 5, 2025

Study Start

October 16, 2025

Primary Completion

January 25, 2026

Study Completion

February 26, 2026

Last Updated

April 13, 2026

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Summary-level data and supporting documents (e.g., study protocol and statistical analysis plan) will be available within 12 months following the final publication of study results and will remain accessible for at least 5 years via institutional repository or upon reasonable request.
Access Criteria
The study's outcome results, including group-level means, standard deviations, p-values, and effect sizes, as well as supporting materials such as the study protocol and statistical analysis plan, will be made available to qualified academic researchers upon reasonable request. Data will be provided for ethically approved, non-commercial research purposes. Interested investigators should contact the principal investigator through the affiliated institution and submit a written request describing the intended use and data handling procedures. Each request will be reviewed individually in accordance with institutional data-sharing guideline.

Locations