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NCT Number: NCT06664229

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

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.

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Key information

Conditions

Dementia, Mild Accidental Falls Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mental Disorders Mild Cognitive Impairment Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea University

Seoul, 02841, South Korea

Location status: Recruiting

Location contact

Junesun Kim, PT/PhD

PRINCIPAL_INVESTIGATOR

Seyun Jang, BS

SUB_INVESTIGATOR

Suk-chan Halm, PT/PhD

SUB_INVESTIGATOR

Sunmi Song, PhD

CONTACT

[email protected]

+821087489593

Sunmi Song, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Fall and dementia prevention exercise

Behavioral

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 that older adults with instability can hold while they follow the movements.

The cognitive exercise will concise of multiple types of cognitive tasks to train memory, numeric processing, spatial perception, and logical thinking. For example, memory task such as memorizing the series of positions on the screen and use the mat to point the positions in the right order.

At the end, older adults play games in which they use balancing movements and cognitive tasks to gain scores for their team.

Primary outcomes

  1. The Mini-Mental State Exam Korean Version (MMSE-K)

    Time frame: 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.

  2. The Berg Balance test

    Time frame: 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.

  3. Sarcopenia index

    Time frame: The test will be conducted at baseline, and at the mid-term assessment, and within one week following the last session of the intervention.

    Sarcopenia-related measures, including appendicular skeletal muscle mass (ASM), appendicular skeletal muscle mass index (ASMI), and handgrip strength, were assessed according to the Asian Working Group for Sarcopenia 2019 criteria

  4. The figure of 8 walk test

    Time frame: 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.

  5. The 3 m sit-walk and return test

    Time frame: 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.

  6. The 30 second sit-stand test

    Time frame: 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.

  7. Montreal Cognitive Assessment (MoCA)

    Time frame: 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 in addition to MMSE.

  8. The 2 minute step in place test

    Time frame: 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.

  9. The sit and reach test (cm)

    Time frame: 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.

Secondary outcomes

  1. Geriatic depression

    Time frame: 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.

  2. Pain related functional limitations

    Time frame: 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.

  3. The Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

  4. The Morse Fall Risk Scale

    Time frame: 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.

  5. WHO quality of life bref

    Time frame: 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.

Other outcomes

  1. System Usability Test

    Time frame: The system usability test will be conducted at baseline, mid-term survey, and within one week following the last session of the intervention.

    System usability test will be conducted to examine changes in the levels of usability for the digital devices that were developed for the intervention program.

Study contacts

Contact information is provided by the study sponsor or research team.

Sunmi Song, PhD

CONTACT

[email protected]

821087489593

Sponsors and collaborators

Lead sponsor

Sunmi Song

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 29, 2024
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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