ELDERLY PEOPLENCT07025278
The Effects of Cognitive-motor Dual-task Intervention on Fall Prevention Among Older Adults
A study testing Medium difficulty fixed priority group and Medium difficulty variable priority group in people with ELDERLY PEOPLE and Cognitive-motor Dual-task, run by Jinyao Wang.
Trial summary
1. Develop an evidence-based dual-task intervention programme incorporating gamification for fall risk reduction in older adults. 2. Examine the effects of the gamified dual-task intervention on fall risk in older adults. 3. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- ELDERLY PEOPLE, Cognitive-motor Dual-task, Fall Prevention
- What is being tested?
- Medium difficulty fixed priority group and Medium difficulty variable priority group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2027to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age ≥ 65 years old;
- Able to walk independently for at least 10 meters without obvious pain or difficulty;
- Free from lower limb and foot deformities, wounds, ulcers, or other diseases, and capable of wearing flexible devices;
- Scored as low or moderate fall risk on the Morse Fall Risk Assessment Scale;
- Scored > 40 points on the Berg Balance Scale and < 20 seconds on the Time Up and Go Test (TUG);
- Scored ≥ 21 points on the Mini-Mental State Examination (MMSE);
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- With an educational level of primary school or above, able to correctly understand instructions and make corresponding responses;
- Without diseases that severely affect cognitive and motor functions, including cardiovascular diseases (such as uncontrolled hypertension, heart failure, etc.), neurological diseases (such as Parkinson's disease, stroke, epilepsy, etc.), musculoskeletal diseases (such as severe arthritis, recent fractures, etc.), etc.;
- Normal vision and hearing or corrected to normal, without affecting the understanding of instructions and participation in interventions;
- Conscious and able to understand the test requirements;
- Able to understand and sign the informed consent form voluntarily, and willing to cooperate in completing the research procedures.
Who cannot join
- Must rely on assistive walking devices or others to walk;
- Individuals with color vision disorders, including various types of color blindness and color weakness;
- Unable to correctly perform addition and subtraction operations;
- Those allergic to the materials of research equipment;
- Currently participating in other research or intervention projects that may affect the effectiveness of this intervention.
About this study
Official title: The Effects and Mechanisms of Game-based Cognitive-motor Dual-task Intervention on Fall Prevention Among Older Adults
- Develop an evidence-based dual-task intervention programme incorporating gamification for fall risk reduction in older adults.
- Examine the effects of the gamified dual-task intervention on fall risk in older adults.
- Elucidate the underlying mechanisms of the optimal gamified dual-task intervention programme in reducing falls in older adults.
- Being tested
- Medium difficulty fixed priority group, Medium difficulty variable priority group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medium difficulty fixed priority groupBehavioural
During the intervention process, participants carried out cognitive and motor tasks simultaneously. They were told to divide attention equally between them and not prioritize one over the other.
Medium difficulty variable priority groupBehavioural
During the intervention process, participants performed medium-difficulty cognitive and motor tasks simultaneously. Participants alter focus between the motor task and the cognitive task every half of the intervention time.
| Study group | Role | What they receive |
|---|---|---|
| Medium difficulty fixed priority group | Experimental | Participants in this group underwent a medium-difficulty and fixed-priority cognitive-motor dual-task fall prevention intervention program Receives: Behavioral: Medium difficulty fixed priority group |
| Medium difficulty variable priority group | Active comparator | Participants in this group underwent a medium-difficulty and variable-priority cognitive-motor dual-task fall prevention intervention program Receives: Behavioral: Medium difficulty variable priority group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of Time up and go test from baseline to the end of the intervention
Measured: From enrollment to the end of the intervention at 3 weeks
Secondary outcomes (4)
The changes of the Berg Balance Scale (BBS) from baseline to the end of the intervention
The minimum and maximum values of the Berg Balance Scale are 0 and 56 points, respectively. The higher the score, the better the balance ability, and the lower the risk of falling.
Measured: From enrollment to the end of the intervention at 3 weeks
The changes of the Mini-Mental State Examination (MMSE) from baseline to the end of the intervention
The minimum and maximum values of the Mini-Mental State Examination (MMSE) are 0 and 30 points, respectively. The higher the score, the better the cognitive function.
Measured: From enrollment to the end of the intervention at 3 weeks
The changes of Trail making test from baseline to the end of the intervention
Measured: From enrollment to the end of the intervention at 3 weeks
The changes of gait from baseline to the end of the intervention
The gait of participants is measured using insole plantar pressure measurement systems to assess the step length, cadence, walking speed, and plantar pressure distribution. The results could determine whether gait abnormalities are present.
Measured: From enrollment to the end of the intervention at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start31 Mar 2027 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ELDERLY PEOPLEStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Sequential Multiple Assignment Randomized Trial (SMART) design was adopted in this study. The SMART intervention consisted of two stages. In the first stage, participants were randomly assigned to either the VP group (receiving variable-priority dual-task intervention) or the FP group (receiving fixed-priority dual-task intervention). Outcome data were collected and assessed immediately after the first-stage intervention, and participants were classified as responders or non-responders based on predefined tailoring variables. Responders in both the VP and FP groups continued with their original intervention protocol in the second stage, whereas non-responders were re-randomized in the second stage. The re-randomization was conducted within their original priority group by adjusting the difficulty level of the intervention, with non-responders being re-assigned to either a difficulty-increase or difficulty-decrease CMDT intervention group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinyao Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jinyao Wang, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025278
- Sponsor's protocol ID
- Ethics No. 2573, 2024
- Status last verified
- Jun 2025
- First submitted
- 1 Jun 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects and Mechanisms of Game-based Cognitive-motor Dual-task Intervention on Fall Prevention Among Older Adults
- ClinicalTrials.gov ID
- NCT07025278
- Acronym / sponsor ID
- Ethics No. 2573, 2024
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Jinyao WangUniversity, hospital or other
- Study start
- 31 Mar 2027 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Develop an evidence-based dual-task intervention programme incorporating gamification for fall risk reduction in older adults.
- Examine the effects of the gamified dual-task intervention on fall risk in older adults.
- Elucidate the underlying mechanisms of the optimal gamified dual-task intervention programme in reducing falls in older adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A Sequential Multiple Assignment Randomized Trial (SMART) design was adopted in this study. The SMART intervention consisted of two stages. In the first stage, participants were randomly assigned to either the VP group (receiving variable-priority dual-task intervention) or the FP group (receiving fixed-priority dual-task intervention). Outcome data were collected and assessed immediately after the first-stage intervention, and participants were classified as responders or non-responders based on predefined tailoring variables. Responders in both the VP and FP groups continued with their original intervention protocol in the second stage, whereas non-responders were re-randomized in the second stage. The re-randomization was conducted within their original priority group by adjusting the difficulty level of the intervention, with non-responders being re-assigned to either a difficulty-increase or difficulty-decrease CMDT intervention group.
| Arm | Type | Receives |
|---|---|---|
| Medium difficulty fixed priority group | Experimental | Behavioral: Medium difficulty fixed priority groupParticipants in this group underwent a medium-difficulty and fixed-priority cognitive-motor dual-task fall prevention intervention program |
| Medium difficulty variable priority group | Active comparator | Behavioral: Medium difficulty variable priority groupParticipants in this group underwent a medium-difficulty and variable-priority cognitive-motor dual-task fall prevention intervention program |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Age ≥ 65 years old;
- Able to walk independently for at least 10 meters without obvious pain or difficulty;
- Free from lower limb and foot deformities, wounds, ulcers, or other diseases, and capable of wearing flexible devices;
- Scored as low or moderate fall risk on the Morse Fall Risk Assessment Scale;
- Scored > 40 points on the Berg Balance Scale and < 20 seconds on the Time Up and Go Test (TUG);
Key exclusion criteria (5 listed)
- Must rely on assistive walking devices or others to walk;
- Individuals with color vision disorders, including various types of color blindness and color weakness;
- Unable to correctly perform addition and subtraction operations;
- Those allergic to the materials of research equipment;
- Currently participating in other research or intervention projects that may affect the effectiveness of this intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medium difficulty fixed priority groupDuring the intervention process, participants carried out cognitive and motor tasks simultaneously. They were told to divide attention equally between them and not prioritize one over the other. | Behavioural | Medium difficulty fixed priority group |
| Medium difficulty variable priority groupDuring the intervention process, participants performed medium-difficulty cognitive and motor tasks simultaneously. Participants alter focus between the motor task and the cognitive task every half of the intervention time. | Behavioural | Medium difficulty variable priority group |
Primary outcome
The changes of Time up and go test from baseline to the end of the intervention
Time frame: From enrollment to the end of the intervention at 3 weeks
4 secondary outcomes
The changes of the Berg Balance Scale (BBS) from baseline to the end of the intervention
Time frame: From enrollment to the end of the intervention at 3 weeks
The changes of the Mini-Mental State Examination (MMSE) from baseline to the end of the intervention
Time frame: From enrollment to the end of the intervention at 3 weeks
The changes of Trail making test from baseline to the end of the intervention
Time frame: From enrollment to the end of the intervention at 3 weeks
The changes of gait from baseline to the end of the intervention
Time frame: From enrollment to the end of the intervention at 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Medium difficulty fixed priority group and Medium difficulty variable priority group in people with ELDERLY PEOPLE and Cognitive-motor Dual-task, run by Jinyao Wang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of Time up and go test from baseline to the end of the intervention (time frame: From enrollment to the end of the intervention at 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.