NCT07547111

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
19mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

March 24, 2026

Completed
24 days until next milestone

Study Start

First participant enrolled

April 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

March 24, 2026

Last Update Submit

April 20, 2026

Conditions

Keywords

dual task trainingcognitive rehabilitationmotor function

Outcome Measures

Primary Outcomes (4)

  • Mini Mental State Examination

    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.

    baseline and at the end of the 8-week intervention

  • The Trail Making Test

    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.

    baseline and at the end of the 8-week intervention

  • The Timed Up And Go Test

    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.

    baseline and at the end of the 8-week intervention

  • The Timed Up and Go dual-task Test

    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.

    baseline and at the end of the 8-week intervention

Secondary Outcomes (3)

  • Lawton Instrumental Activities of Daily Living Scale

    baseline and at the end of the 8-week intervention

  • The Falls Efficacy Scale-International

    baseline and at the end of the 8-week intervention

  • Physical Activity Level

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

Study Arms (2)

Dual Task Group

EXPERIMENTAL

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.

Other: Dual Task Training

Computer-Assisted Cognitive Rehabilitation Group

ACTIVE COMPARATOR

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.

Other: The computer-assisted cognitive rehabilitation

Interventions

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")

Dual Task 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.

Computer-Assisted Cognitive Rehabilitation Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kartal Dr. Lütfi Kırdar Şehir Hastanesi

Istanbul, Kartal, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    PMID: 36002799BACKGROUND
  • 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.

    PMID: 31885287BACKGROUND
  • 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.

    PMID: 19254600BACKGROUND
  • 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.

    PMID: 33239019BACKGROUND
  • 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.

    PMID: 37667883BACKGROUND
  • 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.

    PMID: 23110433BACKGROUND
  • 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.

    PMID: 33604998BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Tülay Ülkü Sevim Çelebi, Research Assistant

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 24, 2026

First Posted

April 23, 2026

Study Start

April 17, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations