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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Medium 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.
• Поведенческое Medium 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.

Первичные конечные точки

• The changes of Time up and go test from baseline to the end of the intervention [Срок оценки: From enrollment to the end of the intervention at 3 weeks]

Вторичные конечные точки (4)

• The changes of the Berg Balance Scale (BBS) from baseline to the end of the intervention [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From enrollment to the end of the intervention at 3 weeks]
• The changes of gait from baseline to the end of the intervention [Срок оценки: From enrollment to the end of the intervention at 3 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07025278 · Ethics No. 2573, 2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗