Development of Pressure Sensor Based Dementia and Fall Prevention Program for Older Adults

Официальное название

Development of the Flexible and Printed Electronic Device for Dementia and Fall Prevention of Older Adults

Обзор

The goal of this intervention program is to test the effectiveness of pressure sensor based dementia and fall prevention program for improving cognitive and physical functions of community dwelling older adults. The main purposes of this study are: 1. Develop a pressure sensor based exercise mat and linked software programs to be used for group training sessions for cognitive and balance training of older adults at a community senior center. 2. Evaluate efficacy of the program to improve cognitive and physical functions of older adults via a pilot study and a main study with randomized control trial design. Older adults will be asked to participate in a group training session that was lead by a fitness coach using a pressure sensor mat, a standing monitor, and a linked software programs. They will be asked to stand on the mat, which is set in front of a monitor to show positions of the mat where they place their foots. The monitor screen will guide them to conduct either a balancing exercise for fall prevention or a cognitive exercise such as memory game or quiz game for dementia prevention. Researchers will compare age and gender matched control group in a main study to see if cognitive and balancing functions of intervention group is better than the control group by conducting pre and post surveys and physical examinations. A pilot study will examine pre-post changes in the intervention group without the control group.

Подробное описание

A. Developed group exercise devices

○ The study will test the flexible, stretchable film-type pressure sensor embedded balance mat and a monitor that will present a sequence of fitness programs and cognitive tasks.

* A 65cm wide balance mat embedded with pressure sensors will be utilized for balance trainings and responding to cognitive tasks. * The devices are consisted of hardware and software based on a thin, flexible pressure sensor (includes additional safety aids such as safety bars and surrounding cushion mats). * The thin pressure sensor allows for a lightweight, portable mat.

B. Pilot Test

* The pilot test will be conducted with a single intervention group who participated in the group exercises using the developed devices that are led by a trainer. * Pre- and post-assessment: Two measurements will be taken before and after the intervention, evaluating balance, physical fitness, cognition, and quality of life. * User-centered interviews: One interview will be conducted after the intervention to gather participants' opinions on the exercise program and to determine the direction of future studies. The interview will use the Metaplan method, which was verified as an effective approach for developing assistive systems for older users in a previous study (Thoma-Lürken et al., 2018). The interview will be conducted with four participants from the pilot test, and the interview session will last 60 to 90 minutes, considering participants' needs for breaks. For effective data collection and analysis, the entire interview process will be recorded with participants' prior consent.

C. The main test

* The main test will be conducted with single-blind, randomized controlled trial (RCT) design. The intervention group will participate in the group exercises using the developed devices that are led by a trainer.

* Random assignment: Block randomization (block size 4) will be applied to randomly assign participants to the intervention group or the control group. * Single-blind (blinding of the evaluator): The evaluator will not be informed of the participants' group allocation during assessments. * Pre-, mid-, and post-assessment: Measurements will be taken three times-before the intervention, after 8 weeks of exercise, and after 16 weeks of exercise-assessing balance, physical fitness, cognition, depression, sleep, and quality of life.

Вмешательства

• Поведенческое Fall and dementia prevention exercise
  The fall and dementia prevention exercise is designed as a combination of balancing and cognitive exercise and games that is conducted as a group activity. The session will be provided three times per week for six weeks for a pilot test and three times per week for 12 weeks for a main comparison study. The fall prevention exercise involves the pressure mat based balancing exercise such as side stepping, heel or toe standing, and quarter squat. The safety bar will be placed around the mat, so th

Первичные конечные точки

• The Mini-Mental State Exam Korean Version (MMSE-K) [Срок оценки: The system usability test will be conducted at baseline and within one week following the last session of the intervention.]
• The Berg Balance test [Срок оценки: The Berg balance test will be conducted at baseline (one week before the first session), mid-term survey (6th week of 12 week program or 8th week of 16 week program), and within one week following the last session of the intervention (13th or 17th week).]
• Sarcopenia index [Срок оценки: The test will be conducted at baseline, and at the mid-term assessment, and within one week following the last session of the intervention.]
• The figure of 8 walk test [Срок оценки: The figure of 8 walk test will be conducted at baseline, mid-term survey, and within one week following the last session of the intervention.]
• The 3 m sit-walk and return test [Срок оценки: The 3 m sit-walk and return test will be conducted at baseline, mid-term survey, and within one week following the last session of the intervention.]
• The 30 second sit-stand test [Срок оценки: The 30 second sit-stand test will be conducted at baseline, mid-term survey, and within one week following the last session of the intervention.]
• Montreal Cognitive Assessment (MoCA) [Срок оценки: MoCA will be conducted at baseline and within one week following the last session of the intervention.]
• The 2 minute step in place test [Срок оценки: The 2 minute step in place test will be conducted at baseline, mid-term survey, and within one week following the last session of the intervention.]
• The sit and reach test (cm) [Срок оценки: The sit and reach test will be conducted at baseline, mid-term survey, and within one week following the last session of the intervention.]

Вторичные конечные точки (5)

• Geriatic depression [Срок оценки: Geriatric depression scale will be conducted at baseline and within one week following the last session of the intervention.]
• Pain related functional limitations [Срок оценки: The WOMAC will be conducted at baseline and within one week following the last session of the intervention.]
• The Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: The PSQI will be conducted at baseline, mid-term survey, and within one week following the last session of the intervention.]
• The Morse Fall Risk Scale [Срок оценки: The system usability test will be conducted at baseline and within one week following the last session of the intervention.]
• WHO quality of life bref [Срок оценки: The system usability test will be conducted at baseline and within one week following the last session of the intervention.]

Критерии участия

Критерии включения

• Older adults in the community who are 65 years old or older.

Критерии исключения

• Older adults who cannot walk independently with assisting devices or use wheelchair.
• Older adults who are diagnosed with dementia, or other neurological/mental disorders that may limit their cognitive ability to participate in the study.
• Older adults who cannot speak or read Korean.

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

Простое слепое

Основная цель

Профилактика

Центры проведения

South Korea · 1 центр

• Korea University — Seoul

Публикации

• Song S, Hahm SC, Chang S, Lee J, Kang H, Lee SH, Kim J. Feasibility and Preliminary Effects of a Pressure Sensor-Based Exergame on Cognitive and Sensorimotor Frailty in Low-Income Older Adults Receiving Public Community Care Services: Pilot Randomized Controlled Trial. JMIR Aging. 2026 Jul 24;9:e93467. doi: 10.2196/93467. PMID 42497405

Идентификаторы

NCT: NCT06664229 · Q2317781

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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