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

Not Applicable

Recruiting

• Conditions: Mild Cognitive Impairment

• Registration Number: NCT06935812
• Lead Sponsor: Eastern Mediterranean University

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.

Detailed Description

Cognitive impairment is one of the most pressing healthcare problems of the 21st century. Mild cognitive impairment (MCI) has been defined as a disorder in a single cognitive function; usually, memory is impaired to an extent greater than anticipated for age, yet the patient does not meet the criteria for dementia. MCI, known as a risk factor for the early stage of dementia, constitutes a risk factor for Alzheimer's Disease (AD) and is also known as the prodromal syndrome of AD. MCI affects 3%-22% of people over the age of 65, depending on demographic characteristics, and persons with MCI (PwMCI) progress to dementia at a rate of 10%-15% every year. Advanced age, low education level, and low cognitive capacity are among the most common risk factors for MCI. Although the pathology of MCI is not completely understood, hippocampal and entorhinal cortex atrophy is defined as a hallmark, and the connectivity of the hippocampus with the prefrontal lobe, temporal lobe, parietal lobe, and cerebellum was found to be lower in PwMCI than healthy controls. PwMCI can be categorized as amnestic and non-amnestic MCI. Individuals with non-amnestic MCI have impairments in other domains than memory, such as attention/executive functions (eMCI), which are frequent and disabling symptoms MCI. It was shown that response inhibition, switching, and cognitive flexibility are selectively impaired, while sustained and divided attention are intact in PwMCI. It has been proposed that executive control and gait share common frontal brain circuitry vulnerable to age-related neuropathology. It is known that cognitive deficits are associated with increased fall risk in community-dwelling older adults, and older adults with higher cognitive impairments are more prone to experience falls. The stepping reaction time variability indicate compromised neural circuitry involved in executive function, gait, and posture and increases the risk of fall in PwMCI.

A promising avenue in this regard is finger or hand exercise, which is rooted in traditional Chinese medicine and grounded in the meridian theory. The meridian theory suggests that specific meridians and acupoints can be stimulated through finger exercises, leading to the promotion of energy flow and restoration of overall balance within the body. While finger exercise has a historical foundation in traditional Chinese medicine, its potential impact on cognitive function has recently gained attention, resulting in several studies investigating its benefits. Notably, two recent randomized controlled trials (RCT) demonstrated that finger exercise improved cognitive performance in both cerebral ischemic stroke (CIS) and mild cognitive impairment (MCI) patients. Despite the promising nature of finger exercises as an effective cognitive intervention highly accessible to older adults, a thorough investigation of their effects is imperative before widespread application.

Study Timeline

• Study First Submitted: 2024-06-01
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-13
• Last Update Submitted: 2025-04-13
• Study First Posted: 2025-04-20
• Last Update Posted: 2025-04-20
• Study Start: 2025-04-29
• Primary Completion: 2025-12-24
• Study Completion: 2025-12-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
MoCA	8 weeks	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.
Cognitive functions-Trail Making Test (A-B)	8 weeks	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.
Cognitive functions-Digit Span Test/Digit Symbol Substitution Test	8 weeks	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.
Cognitive Functions-Verbal Fluency Test/Serial Subtraction Test	8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Choice Stepping Reaction Time Mat (CSRT)	8 weeks	Lower extremity reaction time: Step taking reaction time will be evaluated on the Choice Stepping Reaction Time Mat (CSRT) with Flash/response facilitation (stepping as fast as possible in the direction of the lit green arrow) and Inhibitor/response inhibition (staying in place when the purple arrow is lit and stepping with the green arrow). Accordingly, reaction time, movement time and response/operation time (sum of reaction time and movement time) will be evaluated in all tests.; Upper extremity reaction time: While the participant is in a sitting position, he/she will be asked to touch the buttons (Blaze Pods) on the table as fast as possible when the light is on and the reaction time will be recorded. The test will be performed separately for right and left extremities.

Trial Locations

Locations (1)

Eastern Mediterranean University; 🇨🇾 Famagusta, Eyalet/Yerleşke, Cyprus