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NCT Number: NCT07547111

A Comparison of the Efficacy of Different Rehabilitation Strategies in Mild Cognitive Impairment

The aim of this study is to conduct a comparative analysis of the effects of two different rehabilitation approaches on cognitive and functional outcomes in older adults diagnosed with mild cognitive impairment (MCI).

The study compares two widely used approaches in the field of cognitive rehabilitation: Computer-Based Cognitive Rehabilitation (CBCR) and Dual-Task Training (DTT).

The planned study will be conducted using a randomized controlled, parallel-group experimental design, in which individuals aged 65 and older diagnosed with MCI will be assigned to two intervention groups via computer-assisted randomization. Both groups will receive training for eight weeks, twice a week for 45 minutes each session, under the supervision of a specialist physical therapist. Pre- and post-intervention assessments will measure general cognitive function, executive function, fall risk, dual-task performance, functional independence, fear of falling, and physical activity level.

This study is based on the assumption that cognitive decline is not limited to neuropsychological performance alone but is closely related to motor performance, safe mobility, and quality of life. The findings are expected to contribute to clinical decision-making processes by providing evidence-based data on which rehabilitation approach is more effective and feasible for older adults with HBB.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kartal Dr. Lütfi Kırdar Şehir Hastanesi

Istanbul, Kartal, Turkey (Türkiye)

Location contact

Duygu Erbaş Saçar, MD

SUB_INVESTIGATOR

Tülay Ülkü Sevim Çelebi, Research Assistant

CONTACT

[email protected]

905349787081

About this study

Mild cognitive impairment (MCI) is defined as mild cognitive decline that occurs as a natural consequence of aging. MCI generally represents a transitional stage between healthy aging and dementia. The recognition of MCI as a high-risk intermediate step leading to Alzheimer's disease and other forms of dementia makes early intervention approaches for MCI a priority. Preserving cognitive capacity encompasses not only mental functions but also areas that directly impact quality of life, such as fall risk, functional independence, and physical activity levels. The literature demonstrates that cognitive decline is associated with reduced walking speed, impaired balance control, and decreased ability to perform activities of daily living. Furthermore, a decline in cognitive performance increases the fear of falling, which in turn limits an individual's participation in physical activity and leads to a sedentary lifestyle. The literature indicates that physical activity levels decrease alongside cognitive decline in older adults. Low physical activity levels also increase the risk of falls and limit the ability to maintain independent living.Dual-task training and computer-based cognitive rehabilitation are two important intervention methods developed for cognitive impairments. Dual-task training aims to enhance cognitive-motor integration across multiple domains-including attention, executive functions, processing speed, spatial-visual perception, and postural control-by requiring the simultaneous performance of both cognitive and motor tasks. Dual-task training may also have positive effects on balance, fall risk, and gait in addition to cognitive functions. Computer-assisted cognitive rehabilitation programs, on the other hand, are digital intervention approaches that focus on cognitive domains such as memory, attention, processing speed, and problem-solving; they are individually adaptable and provide systematic progress. It has been reported that these programs have a direct effect on the improvement of cognitive functions.

Studies investigating the specific effects of both approaches are available in the literature; however, there are no studies in the literature comparing the effects of these two intervention methods on cognitive function, functional independence, fall risk, fear of falling, and physical activity levels. Therefore, a comparative evaluation of the effects of different intervention strategies not only on cognitive functions but also on quality-of-life parameters such as fall risk, fear of falling, physical activity level, and functional independence would make significant contributions to determining the approaches to be preferred in clinical practice.Therefore, a comparative evaluation of the effects of different intervention strategies not only on cognitive functions but also on quality-of-life parameters such as fall risk, fear of falling, physical activity level, and functional independence will make a significant contribution to determining the preferred approaches in clinical practice.

The aim of this study is to comparatively examine the effects of dual-task training and computer-based cognitive rehabilitation on cognitive functions, fall risk, functional independence, physical activity level, and fear of falling in older adults with mild cognitive impairment (MCI). By analyzing the effectiveness of both intervention methods on the relevant parameters based on quantitative data, the study aims to identify an effective and feasible intervention approach for preventing or slowing cognitive decline in older adults.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have been diagnosed with mild cognitive impairment
  • Be 65 years of age or older
  • Agree to participate in the study
  • Be literate in Turkish

Exclusion criteria

  • Having been diagnosed with dementia or Alzheimer's disease
  • Having an orthopedic condition that impairs mobility
  • Having a rheumatological condition
  • Having a neurological or psychiatric disorder
  • Having a hearing or visual impairment,
  • Having participated in a cognitive training program within the last 3 months

Treatment and study plan

Dual task training

Other

Week Motor Task Cognitive Task Week 1 Straight walking Counting numbers Week 2 Straight walking Naming fruit images Week 3 Balancing Counting backward (feet together, tandem) Week 4 Throwing a ball Word generation (words starting with 'A') Week 5 Catching a ball Counting by 2s and 4s Week 6 Zigzag walking Reciting days of the week backward Week 7 Walking with obstacles Responding to non-animal words Week 8 Changing direction Verbal commands (e.g., "turn right if yellow, turn left if blue, or vice versa")

The computer-assisted cognitive rehabilitation

Other

The computer-assisted cognitive rehabilitation intervention will be conducted via the RehaCom (Hasomed, Germany) platform. The intervention program is designed to include combinations of modules targeting selective and divided attention, executive functions, processing speed, and visuospatial perception, with each session lasting 40 minutes. It will be implemented in a stepwise manner, with content and difficulty levels gradually increasing every two weeks.

Primary outcomes

  1. Mini Mental State Examination

    Time frame: baseline and at the end of the 8-week intervention

    The Mini-Mental State Examination (MMSE) is a 30-point, 5-10 minute questionnaire used to screen for cognitive impairment, covering orientation, memory, and attention. A score of 25-30 is considered normal, while scores below 24 may indicate impairment, making it crucial for detecting dementia in clinical settings.

  2. The Trail Making Test

    Time frame: baseline and at the end of the 8-week intervention

    The Trail Making Test (TMT) is a common neuropsychological test measuring cognitive flexibility, processing speed, and executive functioning through two parts. Part A requires drawing lines to connect 25 numbered circles in ascending order. Part B requires alternating between numbers and letters (1-A, 2-B, etc.) in ascending order, evaluating the ability to switch between tasks.

  3. The Timed Up And Go Test

    Time frame: baseline and at the end of the 8-week intervention

    The Timed Up and Go (TUG) test is a simple, quick assessment of functional mobility, balance, and fall risk in older adults or those with mobility conditions. It measures the time it takes for an individual to stand from a chair, walk 3 meters (10 feet), turn around, walk back, and sit down.

  4. The Timed Up and Go dual-task Test

    Time frame: baseline and at the end of the 8-week intervention

    The Timed Up and Go (TUG) dual-task test is a clinical assessment that combines the standard TUG mobility test with a simultaneous cognitive task. This method helps evaluate a person's ability to maintain balance and mobility while performing another activity, which is a common real-life scenario.

Secondary outcomes

  1. Lawton Instrumental Activities of Daily Living Scale

    Time frame: baseline and at the end of the 8-week intervention

    The Lawton Instrumental Activities of Daily Living (IADL) Scale is an 8-item survey assessing complex daily tasks (e.g., shopping, cooking, finances) to evaluate independent living skills in older adults. It is widely used by clinicians to detect functional decline or manage care, scoring 0 (dependent) to 8 (independent) in 10-15 minutes.

  2. The Falls Efficacy Scale-International

    Time frame: baseline and at the end of the 8-week intervention

    The Falls Efficacy Scale-International (FES-I) is a widely used 16-item questionnaire designed to measure fear of falling or concern about falling during social and physical activities among older adults. It assesses both basic and more demanding activities (like walking on slippery surfaces or attending social events) on a 4-point scale, with higher total scores (16-64) indicating greater fear of falling.

  3. Physical Activity Level

    Time frame: for 3 days before and at the end of the 8-week intervention

    A Polar Unite watch will be worn for 3 days to determine the level of physical activity. Polar Unite utilizes tri-axial (3D) digital accelerometer technology for the continuous monitoring of physical activity. By recording and analyzing the frequency, intensity, and temporal patterns of wrist movements through sophisticated signal processing algorithms, the device distinguishes between low-intensity activities of daily living (e.g., domestic mobility) and high-intensity aerobic exercises. This kinematic data, integrated with the user's anthropometric profile and basal metabolic rate, provides a valid and reliable estimation of physical activity levels.

Study contacts

Contact information is provided by the study sponsor or research team.

Tülay Ülkü Sevim Çelebi, Research Assistant

CONTACT

[email protected]

905349787081

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

Comparison of the Effectiveness of Dual-Task Training and Computer-Based Cognitive Rehabilitation in Older Adults With Mild Cognitive Impairment

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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