- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07547111
A Comparison of the Efficacy of Different Rehabilitation Strategies in Mild Cognitive Impairment
Comparison of the Effectiveness of Dual-Task Training and Computer-Based Cognitive Rehabilitation in Older Adults With 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tülay Ülkü Sevim Çelebi, Research Assistant
- Phone Number: 905349787081
- Email: tulayulkusevim@gmail.com
Study Locations
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Kartal
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Istanbul, Kartal, Turkey (Türkiye)
- Kartal Dr. Lütfi Kırdar Şehir Hastanesi
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Contact:
- Tülay Ülkü Sevim Çelebi, Research Assistant
- Phone Number: 905349787081
- Email: tulayulkusevim@gmail.com
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Sub-Investigator:
- Duygu Erbaş Saçar, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Dual Task Group
Dual-task training will be implemented in parallel with the cognitive rehabilitation intervention and will be structured to target cognitive domains such as selective and divided attention, executive functions, processing speed, and visuospatial perception.
The intervention will last a total of eight weeks, with content and difficulty levels progressing every two weeks.
The program will begin with a low cognitive load and will be gradually increased in difficulty based on the individual's performance.
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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")
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Active Comparator: Computer-Assisted Cognitive Rehabilitation Group
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mini Mental State Examination
Time Frame: baseline and at the end of the 8-week intervention
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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.
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baseline and at the end of the 8-week intervention
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The Trail Making Test
Time Frame: baseline and at the end of the 8-week intervention
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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.
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baseline and at the end of the 8-week intervention
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The Timed Up And Go Test
Time Frame: baseline and at the end of the 8-week intervention
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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.
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baseline and at the end of the 8-week intervention
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The Timed Up and Go dual-task Test
Time Frame: baseline and at the end of the 8-week intervention
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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.
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baseline and at the end of the 8-week intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Lawton Instrumental Activities of Daily Living Scale
Time Frame: baseline and at the end of the 8-week intervention
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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.
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baseline and at the end of the 8-week intervention
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The Falls Efficacy Scale-International
Time Frame: baseline and at the end of the 8-week intervention
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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.
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baseline and at the end of the 8-week intervention
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Physical Activity Level
Time Frame: for 3 days before and at the end of the 8-week intervention
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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.
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for 3 days before and at the end of the 8-week intervention
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Montero-Odasso M, Verghese J, Beauchet O, Hausdorff JM. Gait and cognition: a complementary approach to understanding brain function and the risk of falling. J Am Geriatr Soc. 2012 Nov;60(11):2127-36. doi: 10.1111/j.1532-5415.2012.04209.x. Epub 2012 Oct 30.
- Sherrington C, Fairhall N, Kwok W, Wallbank G, Tiedemann A, Michaleff ZA, Ng CACM, Bauman A. Evidence on physical activity and falls prevention for people aged 65+ years: systematic review to inform the WHO guidelines on physical activity and sedentary behaviour. Int J Behav Nutr Phys Act. 2020 Nov 26;17(1):144. doi: 10.1186/s12966-020-01041-3.
- Tam ACY, Chan AWY, Cheung DSK, Ho LYW, Tang ASK, Christensen M, Tse MMY, Kwan RYC. The effects of interventions to enhance cognitive and physical functions in older people with cognitive frailty: a systematic review and meta-analysis. Eur Rev Aging Phys Act. 2022 Aug 24;19(1):19. doi: 10.1186/s11556-022-00299-9.
- Nousia A, Martzoukou M, Siokas V, Aretouli E, Aloizou AM, Folia V, Peristeri E, Messinis L, Nasios G, Dardiotis E. Beneficial effect of computer-based multidomain cognitive training in patients with mild cognitive impairment. Appl Neuropsychol Adult. 2021 Nov-Dec;28(6):717-726. doi: 10.1080/23279095.2019.1692842. Epub 2019 Dec 29.
- Silsupadol P, Shumway-Cook A, Lugade V, van Donkelaar P, Chou LS, Mayr U, Woollacott MH. Effects of single-task versus dual-task training on balance performance in older adults: a double-blind, randomized controlled trial. Arch Phys Med Rehabil. 2009 Mar;90(3):381-7. doi: 10.1016/j.apmr.2008.09.559.
- Oliveira JJ, Ribeiro AGSV, de Oliveira Silva JA, Barbosa CGR, Silva ASE, Dos Santos GM, Verlengia R, Pertille A. Association between physical activity measured by accelerometry and cognitive function in older adults: a systematic review. Aging Ment Health. 2023 Nov-Dec;27(11):2089-2101. doi: 10.1080/13607863.2023.2248477. Epub 2023 Sep 5.
- Wang KN, Page AT, Etherton-Beer CD. Mild cognitive impairment: To diagnose or not to diagnose. Australas J Ageing. 2021 Jun;40(2):111-115. doi: 10.1111/ajag.12913. Epub 2021 Feb 18.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Istanbul Üniversitesi Cerrahpa
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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