- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06596993
Developing a Balance Rehabilitation System for Older Adults, Based on IMU and AI: Personalized Training and Preventive Strategies
Developing a Balance Rehabilitation System for Older Adults, Based on Inertial Measurement Unit Sensing and Artificial Intelligence: Personalized Training and Preventive Strategies
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hsu Wei-Li, Ph. D
- Phone Number: 886-2-33668127
- Email: wlhsu@ntu.edu.tw
Study Locations
-
-
-
Taipei, Taiwan, 100
- Recruiting
- National Taiwan University, College of Medicine, School and Graduate Institute of Physical Therapy
-
Contact:
- Hsu Wei-Li, Ph. D
- Phone Number: 886-2-33668127
- Email: wlhsu@ntu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Aged between 18 and 80 years capable of independent walking-
Exclusion Criteria:
- history of lower limb orthopedic surgery, ankylosing spondylitis, rheumatoid arthritis, osteoarthritis, and other medical joint diseases
- Those who cannot communicate or follow instructions, and those with severe visual or hearing impairments
- the neurological impairment or vestibular disorders, such as stroke, spinal cord injury, Meniere's syndrome.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
IMU-based balance training
|
Leveraging AI technology to identify motion deficiencies, the experimental group will undergo IMU-based balance training
|
|
Other: control group
General health education or exercise training
|
general health education or exercise training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Static Standing Balance Test
Time Frame: pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
|
Balance Assessments
|
pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
|
|
Single Leg Standing Test
Time Frame: pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
|
Balance Assessments
|
pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
|
|
Five Times Sit to Stand Test
Time Frame: pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
|
Functional Tests
|
pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
|
|
Timed Up and Go Test
Time Frame: pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
|
Functional Tests
|
pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
|
|
Six-Minute Walk Test
Time Frame: pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
|
Functional Tests
|
pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
|
|
Over-ground walking
Time Frame: pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
|
Walking test
|
pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
|
|
Walking on a treadmill
Time Frame: pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
|
Walking test
|
pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
|
|
Delsys Trigno EMG analysis system
Time Frame: pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
|
Three-Dimensional Motion Analysis
|
pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
|
|
Vicon Bonita
Time Frame: pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
|
Three-Dimensional Motion Analysis
|
pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
|
|
Force plates
Time Frame: pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
|
Three-Dimensional Motion Analysis
|
pre-training, post-training(after 6 weeks), follow-up(after 2 weeks)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202309084RIND
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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