NCT07241598 · NOT YET RECRUITING
Cognitive-motor Training in Community-dwelling Older People With Mild Cognitive Impairment
This trial is testing a device called Smart±step — an interactive stepping platform that combines physical movement with cognitive tasks, like a video game you play with your feet. Researchers want to know if it reduces falls and improves balance, thinking, and quality of life in older adults who already have mild cognitive impairment. This is a Phase NA study, meaning it is a practical real-world effectiveness trial rather than an early safety or drug approval study.
Eligibility criteria
Inclusion Criteria: * Older people with MCI will be identified based on the core criteria outlined by the diagnostic scheme of MCI by Petersen and the National Institute on Aging-Alzheimer's Association and as follows: Subjective cognitive complaints (SCCs) will be assessed using four commonly endorsed items from Slavin et al., with a total score ≥3 indicating SCCs. Objective cognitive impairment will be determined using the Thai version of the Montreal Cognitive Assessment (MoCA), with inclusion criteria defined as MoCA scores of 20-25 for individuals with ≤12 years of education and 21-25 for those with >12 years. Functional ability will be evaluated using the Bayer Activities of Daily Living Scale (B-ADL), with scores \<3 indicating no impairment. Participants with MoCA scores \<20 (≤12 years education) or \<21 (>12 years) will be excluded to rule out dementia. Individuals meeting all four criteria-subjective complaints, objective cognitive impairment, preserved functional abilities, and absence of dementia-will be classified as having MCI. * Aged 60 years or more. * Thai-speaking language and able to read or understand the Thai language * Able to walk 10m independently (without a walking aid) Exclusion Criteria: * Having had a stroke in the last 2 years. * Having a progressive neurodegenerative disorder e.g. Parkinson's disease, Multiple sclerosis, amyotrophic lateral sclerosis (ALS). * Individuals who are blind, deaf, or amputees, whether the condition is congenital or acquired. * A medical condition that would interfere with the safety and conduct of the training and testing protocol or interpretation of the results, such as: 1. Musculoskeletal conditions e.g. severe pain of lower extremities (pain score > 4/10), recent TKR/THR (less than or equal to 12 months after operation) and recent fracture (12-months). 2. Cardiopulmonary conditions e.g. unstable angina, uncontrolled hypertension. 3. Metabolic conditions e.g. severe or poorly controlled diabetes. 4. Mental health conditions e.g. severe or poorly controlled depression or psychiatric condition.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-11-21