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

NCT07025278 | Not Yet Recruiting

• 1 other identifier: Ethics No. 2573, 2024
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Develop an evidence-based dual-task intervention programme incorporating gamification for fall risk reduction in older adults.
2. 2.Examine the effects of the gamified dual-task intervention on fall risk in older adults.
3. 3.Elucidate the underlying mechanisms of the optimal gamified dual-task intervention programme in reducing falls in older adults.

Conditions

ELDERLY PEOPLE; Cognitive-motor Dual-task; Fall Prevention; Intervention

Outcome Measures

Primary Outcomes (1)

• The changes of Time up and go test from baseline to the end of the intervention

  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

  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

  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

  From enrollment to the end of the intervention at 3 weeks

• The changes of gait from baseline to the end of the intervention

  From enrollment to the end of the intervention at 3 weeks

Other Outcomes (3)

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

  From enrollment to the end of the intervention at 3 weeks

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

  From enrollment to the end of the intervention at 3 weeks

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

  From enrollment to the end of the intervention at 3 weeks

Study Arms (2)

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

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

Behavioral: Medium difficulty variable priority group

Interventions

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 fixed priority group

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.

Medium difficulty variable priority group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinyao Wang: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Given the inherent nature of the intervention, blinding of participants and intervention providers was not feasible; only the outcome assessors were kept blinded to group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2025
• First Posted: June 17, 2025
• Study Start (Estimated): March 31, 2027
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 29, 2026

Record last verified: 2025-06