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

NCT ID: NCT06935812

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-29
• Study Completion Date: 2025-12-24

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bimanual Exercise

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.

Group Type: EXPERIMENTAL

Bimanual Exercise

Intervention Type: 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.

Finger Exercise

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.

Group Type: EXPERIMENTAL

Finger Exercise

Intervention Type: 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.

Virtual Reality

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.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: 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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eastern Mediterranean University

OTHER

Sponsor Role: lead

Responsible Party

Betül Fatma Bilgin

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Betül Fatma Bilgin, MSc PT

Role: PRINCIPAL_INVESTIGATOR

Eastern Mediterranean University

Gözde İyigün, PhD

Role: STUDY_DIRECTOR

Eastern Mediterranean University

Locations

Eastern Mediterranean University

Famagusta, Eyalet/Yerleşke, Cyprus

Site Status: RECRUITING

Countries

Cyprus

Central Contacts

Betül Fatma Bilgin, MSc PT

Role: CONTACT

betulll_96@hotmail.com

3926303011

Gözde İyigün, PhD

Role: CONTACT

gozde.iyigun@emu.edu.tr

3926303011

Facility Contacts

Betül F Bilgin, MSc, PT

Role: primary

betulll_96@hotmail.com

Gözde İyigün, PhD, PT

Role: backup

gozde.iyigun@emu.edu.tr

Other Identifiers

ETK00-2024-0113

Identifier Type: -

Identifier Source: org_study_id