Clinical trial NCT07025278: The Effects of Cognitive-motor Dual-task Intervention on Fall Prevention Among Older Adults
Official title: The Effects and Mechanisms of Game-based Cognitive-motor Dual-task Intervention on Fall Prevention Among Older Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ELDERLY PEOPLE
Cognitive-motor Dual-task
Fall Prevention
Intervention
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. Elucidate the underlying mechanisms of the optimal gamified dual-task intervention programme in reducing falls in older adults.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 65 years old;
2. Able to walk independently for at least 10 meters without obvious pain or difficulty;
3. Free from lower limb and foot deformities, wounds, ulcers, or other diseases, and capable of wearing flexible devices;
4. Scored as low or moderate fall risk on the Morse Fall Risk Assessment Scale;
5. Scored \> 40 points on the Berg Balance Scale and \< 20 seconds on the Time Up and Go Test (TUG);
6. Scored ≥ 21 points on the Mini-Mental State Examination (MMSE);
7. With an educational level of primary school or above, able to correctly understand instructions and make corresponding responses;
8. 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.;
9. Normal vision and hearing or corrected to normal, without affecting the understanding of instructions and participation in interventions;
10. Conscious and able to understand the test requirements;
11. Able to understand and sign the informed consent form voluntarily, and willing to cooperate in completing the research procedures.

Exclusion Criteria:

1. Must rely on assistive walking devices or others to walk;
2. Individuals with color vision disorders, including various types of color blindness and color weakness;
3. Unable to correctly perform addition and subtraction operations;
4. Those allergic to the materials of research equipment;
5. Currently participating in other research or intervention projects that may affect the effectiveness of this intervention.

Primary outcomes:
measure: The changes of Time up and go test from baseline to the end of the intervention
timeFrame: From enrollment to the end of the intervention at 3 weeks
Secondary outcomes:
measure: The changes of the Berg Balance Scale (BBS) from baseline to the end of the intervention
timeFrame: From enrollment to the end of the intervention at 3 weeks
measure: The changes of the Mini-Mental State Examination (MMSE) from baseline to the end of the intervention
timeFrame: From enrollment to the end of the intervention at 3 weeks
measure: The changes of Trail making test from baseline to the end of the intervention
timeFrame: From enrollment to the end of the intervention at 3 weeks
measure: The changes of gait from baseline to the end of the intervention
timeFrame: From enrollment to the end of the intervention at 3 weeks
Other outcomes:
measure: The changes of the Falls Efficacy Scale-International (FES-I) from baseline to the end of the intervention
timeFrame: From enrollment to the end of the intervention at 3 weeks
measure: The changes of 12-Item Health Survey from baseline to the end of the intervention
timeFrame: From enrollment to the end of the intervention at 3 weeks
measure: The changes of the Geriatric Depression Scale (GDS) from baseline to the end of the intervention
timeFrame: From enrollment to the end of the intervention at 3 weeks
Locations:
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