About this trial
Mild and Moderate cognitive impairment is a condition characterized by a noticeable decline in cognitive abilities, including memory and thinking skills, which is greater than expected for an individual's age but does not significantly interfere with daily life. Early intervention is essential to prevent further cognitive decline and progression to dementia.
Dual-task training has emerged as an effective rehabilitation approach that combines cognitive and motor tasks to enhance neuroplasticity and improve both physical and cognitive performance. This study is designed to investigate the effectiveness of dual-task training compared to conventional therapy in individuals with mild cognitive impairment.
Participants meeting the inclusion criteria will be recruited and randomly allocated into intervention and control groups. The intervention group will receive structured dual-task training, which may include activities such as walking while performing cognitive tasks (e.g., counting, word recall), balance exercises combined with mental tasks, and functional activities requiring divided attention. The control group will receive standard rehabilitation or single-task training.
The intervention will be conducted over a specified duration (e.g., several weeks), with sessions held multiple times per week. Outcome measures will be assessed at baseline and after completion of the intervention. The primary outcome will be cognitive function measured using the Mini-Mental State Examination (MMSE). Secondary outcomes may include balance, mobility, and functional performance.
Data will be analyzed to determine the effectiveness of dual-task training in improving cognitive and functional outcomes. The results of this study may contribute to evidence-based rehabilitation practices and support the use of dual-task interventions in clinical settings.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age > 55 years
MoCA: 10-25
MMSE: 10-23
Diagnosed cognitive impairment
Disqualifiers
Severe cognitive impairment
Severe physical sensory limitations
Unstable medical conditions
Participation in other trials
Trial design
Parallel
Treatments tested in this trial
Integrated Dual-Task Training
BehavioralParticipants will perform motor and cognitive tasks simultaneously (integrated dual-task training). The intervention includes balance and gait exercises combined with cognitive activities such as counting, memory, and executive function tasks. Training will be conducted for 8 weeks, 3 sessions per week, with each session lasting 45 minutes.
Sequential Dual-Task Training
BehavioralParticipants will perform motor and cognitive tasks separately (sequential dual-task training). Motor exercises (balance, gait training) and cognitive tasks (memory, attention, executive function) will be administered in sequence. The intervention will last 8 weeks, with 3 sessions per week, each session lasting 45 minutes.
Treatment groups
Trial outcomes
Primary outcomes
Functional Mobility (Timed Up and Go Test) Change from Baseline in Timed Up and Go (TUG) Test Time at 8 Weeks
Functional mobility will be evaluated using the Timed Up and Go (TUG) test. It measures the time (in seconds) taken by a participant to stand up from a chair, walk 3 meters, turn, walk back, and sit down. Lower times indicate better mobility. Functional mobility and balance will be assessed using the Timed Up and Go (TUG) test, a simple and widely used clinical measure of mobility and fall risk. In this test, participants are required to stand up from a standard chair, walk a distance of 3 meters, turn around, walk back to the chair, and sit down. The total time taken to complete the task is recorded in seconds. Shorter completion times indicate better functional mobility and balance, while longer times indicate impaired mobility and increased risk of falls. A time of less than 10 seconds is considered normal for healthy adults, 10-19 seconds indicates good mobility, 20-29 seconds suggests variable mobility, and 30 seconds or more indicates impaired mobility and a higher risk of falls
Executive Function (Trail Making Test) Change from Baseline in Trail Making Test (Part A and Part B) Completion Time at 8 Weeks
Executive function will be assessed using the Trail Making Test (TMT Parts A and B), which evaluates cognitive flexibility, processing speed, and task-switching ability. Performance is measured by completion time in seconds. Cognitive function, specifically attention, processing speed, and executive function, will be assessed using the Trail Making Test (TMT). The test consists of two parts: Part A and Part B. In Part A, participants are required to connect numbered dots in sequential order as quickly as possible, assessing visual scanning and processing speed. In Part B, participants alternate between numbers and letters in sequence (e.g., 1-A-2-B), assessing executive function and task-switching ability. The outcome is measured as the time (in seconds) taken to complete each part. Longer completion times indicate poorer cognitive performance, while shorter times indicate better cognitive performance. The Trail Making Test will be administered at baseline and after completion of the
Global Cognitive Function (Montreal Cognitive Assessment) Change from Baseline in Montreal Cognitive Assessment (MoCA) Score at 8 Weeks
Global cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). It evaluates multiple cognitive domains including attention, memory, language, visuospatial ability, and executive function. Scores range from 0 to 30, with higher scores indicating better cognitive performance. Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a standardized screening tool designed to detect mild cognitive impairment. The MoCA evaluates multiple cognitive domains including attention, executive function, memory, language, visuospatial skills, abstraction, calculation, and orientation. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance and lower scores indicating greater cognitive impairment. A score of 26 or above is generally considered normal cognitive function. The MoCA will be administered at baseline and after completion of the intervention period to assess changes in cognitive function.
Balance Performance (Berg Balance Scale) Change from Baseline in Berg Balance Scale (BBS) Score at 8 Weeks
Balance will be assessed using the Berg Balance Scale (BBS), a 14-item objective measure designed to assess static and dynamic balance abilities in older adults. Scores range from 0 to 56, with higher scores indicating better balance performance. Balance will be assessed using the Berg Balance Scale (BBS), a standardized clinical tool used to evaluate static and dynamic balance abilities. The BBS consists of 14 functional tasks, including sitting, standing, transferring, reaching, turning, and single-leg stance. Each item is scored on a 5-point scale ranging from 0 to 4, with a maximum total score of 56. Higher scores indicate better balance performance, while lower scores indicate greater balance impairment and increased risk of falls. A score of 41-56 indicates low fall risk, 21-40 indicates medium fall risk, and 0-20 indicates high fall risk. The BBS will be administered at baseline and after completion of the intervention period to assess changes in balance performance.
Secondary outcomes
Quality of Life Change from Baseline in WHO Quality of Life-BREF (WHOQOL-BREF) Score at 6 Weeks
Quality of life will be measured using the WHOQOL-BREF questionnaire, which assesses physical health, psychological health, social relationships, and environmental domains. Higher scores indicate better quality of life. Quality of life will be assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire, a standardized instrument that evaluates individuals' perception of their position in life in the context of culture and value systems. The WHOQOL-BREF consists of 26 items covering four domains: physical health, psychological health, social relationships, and environmental well-being. Each item is scored on a 5-point Likert scale, and domain scores are transformed to a scale of 0 to 100, with higher scores indicating better quality of life. The WHOQOL-BREF will be administered at baseline and after completion of the intervention period to assess changes in quality of life.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.