Cognitive-motor Dual-task, ELDERLY PEOPLE, Fall Prevention, Intervention
Conditions
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.
Interventions
BEHAVIORALMedium difficulty fixed priority group
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.
BEHAVIORALMedium difficulty variable priority group
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.
Sponsors
Jinyao Wang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 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. |
| 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 | 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. |
Outcome results
None listed