Clinical trial NCT06596993: Developing a Balance Rehabilitation System for Older Adults, Based on IMU and AI: Personalized Training and Preventive Strategies
Official title: Developing a Balance Rehabilitation System for Older Adults, Based on Inertial Measurement Unit Sensing and Artificial Intelligence: Personalized Training and Preventive Strategies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Community-dwelling Older Adults
Keywords: Inertial Measurement Unit Sensing
Artificial Intelligence
Balance Rehabilitation
Older Adults
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aging physiological state of the elderly may lead to problems such as unstable gait, balance disorders, and falls. Previous research has confirmed that exercise training can help improve the physical function, quality of life, and reduce the risk of falls in the elderly. In order to achieve effective and continuous intervention training, somatosensory games have become a trend in recent years. Among them, the use of non-immersive virtual reality training methods not only provides training for the elderly, but also reduces the discomfort caused by the virtual environment; however, there are some limitations in clinical rehabilitation training methods, such as the lack of data-based evaluation and personalization. In order to solve the above problems, this research plan will use the inertial measurement unit as a tool for clinical monitoring and human movement assessment, and use artificial intelligence technology to evaluate and adjust the training plan according to its gait characteristics to achieve personalization Training and prevention strategies.

Detailed description: The development of a balance rehabilitation system for older adults, integrating Inertial Measurement Unit (IMU) sensing and Artificial Intelligence (AI). The key technical components and methodology are as follows:

Technological Foundation:

IMU sensors will be used to monitor and assess human movement and posture. These sensors detect motion through accelerometers, gyroscopes, and magnetometers, allowing for precise gait analysis.

AI and Generative Adversarial Networks (GAN) will process the data to customize training regimens based on the individual's physiological and movement characteristics.

A Vicon 3D motion capture system will be used in conjunction with IMUs for validating and collecting data during the development phase.

Research Phases:

Year 1: Developing an AI-based gait training system using IMUs. This involves creating a gait database and balance training protocols using bilateral and unilateral movements.

Year 2: Optimizing the training system using AI and GAN to diversify the data and improve training efficacy.

Year 3: Clinical validation of the system by comparing results between participants undergoing IMU-based training versus standard physical exercises.

Training Protocols:

Exergame Environment: Participants engage in exercises within a virtual environment, which mimics real-world conditions but includes artificial elements to challenge balance and coordination.

Balance Training: Skateboard-based training focuses on unilateral leg movements, monitored by IMUs to provide feedback and adjust difficulty based on performance.

Data Analysis:

Gait Data: AI and GAN are used to generate personalized gait profiles, which will feed into the training system.

Statistical Analysis: Various statistical tests (e.g., ANOVA) will assess the effectiveness of the system compared to conventional rehabilitation methods.

This system aims to provide older adults with personalized rehabilitation, reducing fall risk and enhancing their quality of life.

Eligibility criteria: Inclusion Criteria:

Aged between 18 and 80 years capable of independent walking-

Exclusion Criteria:

1. history of lower limb orthopedic surgery, ankylosing spondylitis, rheumatoid arthritis, osteoarthritis, and other medical joint diseases
2. Those who cannot communicate or follow instructions, and those with severe visual or hearing impairments
3. the neurological impairment or vestibular disorders, such as stroke, spinal cord injury, Meniere's syndrome.

Primary outcomes:
measure: Static Standing Balance Test
timeFrame: pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
measure: Single Leg Standing Test
timeFrame: pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
measure: Five Times Sit to Stand Test
timeFrame: pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
measure: Timed Up and Go Test
timeFrame: pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
measure: Six-Minute Walk Test
timeFrame: pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
measure: Over-ground walking
timeFrame: pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
measure: Walking on a treadmill
timeFrame: pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
measure: Delsys Trigno EMG analysis system
timeFrame: pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
measure: Vicon Bonita
timeFrame: pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
measure: Force plates
timeFrame: pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University, College of Medicine, School and Graduate Institute of Physical Therapy
Study officials:
References: