Development of Pressure Sensor Based Dementia and Fall Prevention Program for Older Adults
- Conditions
- Dementia, MildAccidental FallsMild Cognitive Impairment
- Registration Number
- NCT06664229
- Lead Sponsor
- Sunmi Song
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 205
- Older adults in the community who are 65 years old or older.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The Berg Balance test 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). The Berg Balance test (Lusardi, 2004) ranges from 0 to 56 with lower score indicating the more risk of losing one's balance.
The Mini-Mental State Exam Korean Version (MMSE-K) The system usability test will be conducted at baseline and within one week following the last session of the intervention. The Mini-Mental State Exam Korean version (MMSE-K) ranges from 0-30 with higher score indicating better cognitive function.
The Morse Fall Risk Scale The system usability test will be conducted at baseline and within one week following the last session of the intervention. The Morse Fall Risk Scale ranges 0-125 with higher score indicating higher risk of fall.
Montreal Cognitive Assessment (MoCA) MoCA will be conducted at baseline and within one week following the last session of the intervention. MoCA test will be conducted to examine changes in cognitive functioning before and after the intervention program.
Grip test The grip test will be conducted at baseline, and at the mid-term assessment, and within one week following the last session of the intervention. A test that measures left and right grip strength (kg). The larger the test score, the stronger the grip strength.
The 30 second sit-stand test 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. The 30 second sit-stand test measures the number of completed chair stands in 30 seconds. The larger number of completed chair stands, the better physical fitness of a participant.
The 2 minute step in place test 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 2 minute step in place test (number): A test that measures the total number of times the right knee reaches the tape level in two minutes. The more number of reaches, the better fitness scores the participant has.
The sit and reach test (cm) The sit and reach 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) measures the distance reached by the hand. The participant sits on the floor with legs stretched out straight ahead, with the soles of the feet flat against the box. Both knees should be locked and pressed flat to the floor. Reach forward with a slow and steady movement as far as possible, and hold that position for three seconds while the distance is recorded. The larger scores indicate the better fitness of the participant.
The 3 m sit-walk and return test 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 3 m sit-walk and return test measures the time (seconds) from sitting on a chair to standing, walking to a 3 m target, and then returning to the chair and sitting down. The shorter test score indicates better fitness of a participant.
The figure of 8 walk test 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 figure of 8 walk test measures the time (seconds) to walk a figure-of-eight around 2 cones placed 2.4 m apart twice. The smaller score indicates the better walking ability of a participant.
- Secondary Outcome Measures
Name Time Method Geriatic depression Geriatric depression scale will be conducted at baseline and within one week following the last session of the intervention. Geriatric depression scale score ranges from 0-15 with higher scores indicating more severe depressive symptoms.
Pain related functional limitations The WOMAC will be conducted at baseline and within one week following the last session of the intervention. The brief version of the Western Ontario and McMaster Universities Osteoarthritis Index, which measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68), with higher scores indicating worse pain and functional limitations in one's daily living.
The Pittsburgh Sleep Quality Index (PSQI) The PSQI will be conducted at baseline, mid-term survey, and within one week following the last session of the intervention. The brief version of the Pittsburgh Sleep Quality Index ranges from 0 to 15 with higher score indicating more sleep problems.
WHO quality of life bref 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 assesses physical, psychological, social, environmental health, which ranges 7-35, 6-30, 3-15, 8-40, respectively, higher score indicating better physical, psychological, social, environmental health status.
Trial Locations
- Locations (1)
Korea University
🇰🇷Seoul, Korea, Republic of