Clinical trial NCT07005271: VR Hand Exercises: Impact on Cognition and Dexterity in MCI
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment (MCI)
Keywords: virtual reality
hand exercise
mild cognitive impairment
cortical activation
hand dextery
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Cortical Hemodynamics (Functional Near-Infrared Spectroscopy)
timeFrame: before treatment, week 6
measure: Hand skills (Minnesota Manual Dexterity Test)
timeFrame: before treatment, week 6
measure: Activities of daily living (Duruöz Hand Index)
timeFrame: before treatment, week 6
Secondary outcomes:
measure: Gross grip strength (Jamar hand dynamometer)
timeFrame: before treatment, week 6
measure: Determination of hand preference (Edinburgh Handedness Inventory)
timeFrame: before treatment
Other outcomes:
Locations:
Study officials:
affiliation: Istinye University
name: Berrak Varhan
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.