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NCT Number: NCT07025278

The Effects of Cognitive-motor Dual-task Intervention on Fall Prevention Among Older Adults

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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);
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Medium difficulty fixed priority group

Behavioral

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 group

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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 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.

  2. 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 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.

  3. 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

  4. 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

    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.

Other outcomes

  1. The changes of the Falls Efficacy Scale-International (FES-I) from baseline to the end of the intervention

    Time frame: From enrollment to the end of the intervention at 3 weeks

    The minimum and maximum values of the Falls Efficacy Scale-International (FES-I) are 16 and 64 points, respectively. A higher score indicates a greater degree of an individual's concern about falling.

  2. The changes of 12-Item Health Survey from baseline to the end of the intervention

    Time frame: From enrollment to the end of the intervention at 3 weeks

  3. The changes of the Geriatric Depression Scale (GDS) from baseline to the end of the intervention

    Time frame: From enrollment to the end of the intervention at 3 weeks

    The minimum and maximum scores of the Geriatric Depression Scale (GDS) are 0 and 30 points, respectively. A higher score indicates more severe depressive symptoms in individuals.

Sponsors and collaborators

Lead sponsor

Jinyao Wang

Other

Registry information

Official study title

The Effects and Mechanisms of Game-based Cognitive-motor Dual-task Intervention on Fall Prevention Among Older Adults

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Jun 17, 2025
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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