Comparison of the Effects of Bimanual, Finger and VR Exercises in PwMCI

NCT06935812 | Recruiting

• 1 other identifier: ETK00-2024-0113
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

Mild Cognitive Impairment (MCI) is defined as an impairment in a single cognitive function, usually memory, other than normal cognitive decline with age, that does not fulfil dementia criteria. Finger movements have been shown to stimulate the sensory-motor and cognitive parts of the cerebral cortex, as well as the supplementary motor area, Broca's area, premotor cortex, and prefrontal cortex, all of which contribute to movement skills. Asymmetrical hand and finger movements done concurrently were proven to improve cognitive processes and cerebral blood flow more than movements performed with one hand.

Conditions

Mild Cognitive Impairment

Keywords

Finger Exercise; Bimanual Exercise; Virtual Reality; Processing Speed; Cognitive Functions; Walking Speed; Gross Motor Skills; Fine Motor Skills; Dual Task

Outcome Measures

Primary Outcomes (4)

• MoCA

  Montreal Cognitive Assessment Scale: MoCA is a short screening test for Mild Cognitive Impairment and Alzheimer's Disease to measure cognitive functions. The test is administered using pen and paper and takes approximately 10-20 minutes. It has 7 subheadings and these are listed as follows: (1) visuospatial/executive functions (clock drawing and cube copying, tracing test (part B) - 5 points); (2) naming (learning and repeating a list of 5 words - 3 points); (3) memory (5 points for recall); (4) attention (target-orientated clapping - 6 points); (5) language (fluency - 3 points); (6) abstract thinking (similarity between words - 2 points); and (7) orientation (knowledge of day, month, year and place - 6 points). The score range is 0 to 30, with higher scores indicating better performance. Values below 26 points indicate a risk of cognitive impairment and provide information about a possible MCI.

  8 weeks

• Cognitive functions-Trail Making Test (A-B)

  Trail Making Test (A-B): Trail Making Test (TMT) is a complex visual screening test with motor components and is sensitive to frontal region functions (12, 13). Motor speed, agility and careful participation are required to be successful in this test. This first version of the IST consists of two parts (forms), A and B. In Part A, the participants will be asked to connect the circles with numbers (1-2-3-4-......) on the test form by drawing a line consecutively and in the correct order. In Part B, the participants will be asked to connect the circles containing numbers and letters (1-A,2-B,3-C- ......) on the test form by drawing a line in a consecutive and correct order in accordance with the order of one number and one letter. The time will be recorded for both A and B tests.

  8 weeks

• Cognitive functions-Digit Span Test/Digit Symbol Substitution Test

  Digit Span Test (DST): In the DST, participants will be asked to repeat the read digits in sequence. The test continues with growing digits. Then, in the second part of the test, they will be asked to repeat the spoken digits backwards and the number of correct ones will be recorded. Digit Symbol Substitution Test (DSST): DSST is a test used to evaluate psychomotor performance. The participants will be asked to draw the symbol determined for each number in the boxes left blank for 90 seconds. The total number of correct shapes will be recorded.

  8 weeks

• Cognitive Functions-Verbal Fluency Test/Serial Subtraction Test

  Verbal Fluency Test - Phonemic: The participant is asked to count the words starting with the letters we have determined (letters A and S) within 1 minute. The number of correct and incorrect words spoken will be determined. Serial Subtraction Test: The participant is asked to count backwards by subtracting 7 from a number between 200-300 within 1 minute. The number of correct and incorrect counts will be determined.

  8 weeks

Secondary Outcomes (1)

• Choice Stepping Reaction Time Mat (CSRT)

  8 weeks

Other Outcomes (6)

• Grip Strength

  8 weeks

• Fine motor skills

  8 weeks

• Gross motor skills

  8 weeks

Study Arms (4)

Bimanual Exercise

EXPERIMENTAL

Bimanual Exercise The bimanual exercise group consists of exercises that involve movements in which both hands are used simultaneously. The bimanual exercise group will have 40 minutes of training for 3 sessions per week for 8 weeks.

Other: Bimanual Exercise

Finger Exercise

EXPERIMENTAL

Finger Exercise The finger exercise group consists of exercises that involve finger movements. The bimanual exercise group will have 40 minutes of training for 3 sessions per week for 8 weeks.

Other: Finger Exercise

Virtual Reality

EXPERIMENTAL

Virtual Reality The virtual reality exercise group consists of hand-tracking game exercises that involve finger movements. The bimanual exercise group will have 40 minutes of training for 3 sessions per week for 8 weeks.

Other: Virtual Reality

Control

NO INTERVENTION

In this group, participants will asses on the first and the last weeks of the program (0. and 8. week).

Interventions

Bimanual Exercise OTHER

The bimanual exercise group consists of exercises that involve movements in which both hands are used simultaneously. The bimanual exercise group will have 40 minutes of training for 3 sessions per week for 8 weeks.

Bimanual Exercise

Finger Exercise OTHER

The finger exercise group consists of exercises that involve finger movements. The bimanual exercise group will have 40 minutes of training for 3 sessions per week for 8 weeks.

Finger Exercise

Virtual Reality OTHER

The virtual reality exercise group consists of hand-tracking game exercises that involve finger movements. The bimanual exercise group will have 40 minutes of training for 3 sessions per week for 8 weeks.

Virtual Reality

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who are between 50-75 years of age
• Individuals diagnosed with MCI by a geriatrician according to DSM-5 criteria,
• Who has the Montreal Cognitive Assessment score between 13-26,
• Who has the Quick Mild Cognitive Impairment screen score between 48-67,
• Who has Instrumental Activities of Daily Living Scale score ≥6/8,
• Who says yes to "Do you have a memory problem?" question,
• Who can walk independently without using any walking aids

You may not qualify if:

• Participants who have any musculoskeletal disorders that may cause balance and gait disorders,
• Who have central or peripheral neurological diseases (eg. stroke, Parkinson's disease or polyneuropathies),
• Who are using psychiatric drugs that may affect psychiatric disease and/or cognitive performance (Using nonsteroidal anti-inflammatory drugs more than three times a week, which may affect cognitive functions, using gingko biloba and antioxidant supplements (for example, coenzyme Q10 and alpha-lipoic acid)),
• Who has daltonism and
• Who attends any exercise program last 6 months will not be included in this study.

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Eastern Mediterranean University

Famagusta, Eyalet/Yerleşke, 99450, Cyprus

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Betül Fatma Bilgin, MSc PT

  Eastern Mediterranean University

  PRINCIPAL INVESTIGATOR

• Gözde İyigün, PhD

  Eastern Mediterranean University

  STUDY DIRECTOR

Central Study Contacts

Betül Fatma Bilgin, MSc PT

CONTACT

3926303011; betulll_96@hotmail.com

Gözde İyigün, PhD

CONTACT

3926303011; gozde.iyigun@emu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: June 1, 2024
• First Posted: April 20, 2025
• Study Start: April 29, 2025
• Primary Completion: December 24, 2025
• Study Completion: December 24, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

CY (1)