Exergame aims to cut fall risk in seniors with mild cognitive impairment

NCT ID NCT07241598

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a computer-based stepping game, called Smart±step, can help older adults with mild cognitive impairment (MCI) improve their balance, thinking, and quality of life while reducing their risk of falling. About 70 participants will use the game, which combines mental challenges with physical stepping tasks. The goal is to see if this fun, interactive approach can prevent falls and boost overall function in a group that is five times more likely to fall than other older adults.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction dementia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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Contacts and locations

Locations

  • Faculty of Physical Therapy

    Salaya, Changwat Nakhon Pathom, 73170, Thailand

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