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NCT Number: NCT07133724

Digital Health for Lumbar Degeneration

This study will integrate wireless wearable sensors, smartphone imaging, and multimodal artificial intelligence (AI) to address the rehabilitation needs of patients with lumbar degeneration. Patients will undergo comprehensive functional assessments, and individualized exercise instruction with real-time feedback will be provided through a smartphone application. The goals of this research are to: (1) develop a multimodal AI-based digital health system combining IMU sensors and smartphone cameras for real-time assessment and interactive rehabilitation training, (2) construct biomechanics- and gait-analysis models to support personalized rehabilitation for patients with lumbar degeneration, and (3) investigate the mechanisms and clinical efficacy of pelvic control exercise training combined with real-time smartphone feedback in improving function and quality of life for aging patients.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The multimodal AI-based smart assessment and rehabilitation training system developed in this study will provide patients with lumbar degeneration a convenient and precise home-based rehabilitation solution. Through the integration of wireless inertial sensors and smartphone imaging, the system can monitor pelvic and lumbar movements in real time, generate a digital twin model, and deliver instant feedback to guide patients in performing correct exercises. This design not only improves patients' self-awareness of posture and movement but also reduces the risk of improper compensatory strategies that often occur in traditional home exercise programs.

The system is particularly suitable for older adults with mobility limitations or those who have difficulties frequently visiting medical institutions. By enabling remote assessment, individualized training, and long-term monitoring, this platform ensures continuity of care and enhances patients' motivation to engage in rehabilitation. The outcomes of this project will establish a tele-rehabilitation system tailored to degenerative lumbar spine disease, support clinicians in delivering precise and effective treatment, and ultimately reduce the healthcare and economic burden on families and society.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age between 50-80 years to capture the typical characteristics of lumbar degeneration in this age group.
  • No history of low back pain lasting more than one week or severe enough to interrupt work within the past year.
  • Normal lumbar functional mobility.
  • Ability to walk independently for more than 10 meters.

Exclusion criteria

  • Presence of systemic joint diseases such as ankylosing spondylitis, rheumatoid arthritis, or multiple sclerosis, which may significantly affect lumbar mobility and gait patterns.
  • Central nervous system disorders (e.g., spinal cord injury, stroke, or Parkinson's disease) that may influence gait and motor control.
  • Vestibular system disorders, to avoid balance abnormalities interfering with gait testing.
  • History of spinal or lower limb surgery, as postoperative changes may affect the accuracy of gait data.
  • Inability to communicate or follow instructions.

Treatment and study plan

AI-Based Smart Assessment and Rehabilitation Training

Other

Through the integration of wireless inertial sensors and smartphone imaging, the system can monitor pelvic and lumbar movements in real time, generate a digital twin model, and deliver instant feedback to guide patients in performing correct exercises.

Primary outcomes

  1. Functional assessment: Walking speed

    Time frame: 6 months

    Functional assessment is a process that allows for the identification of disability. The data from the functional assessment is used to calculate walking speed (unit: m/s).

  2. Functional assessment: Walking distance

    Time frame: 6 months

    Functional assessment is a process that allows for the identification of disability. The data from the functional assessment is used to calculate walking distance (unit: m).

  3. Functional assessment: 5 Times Sit to Stand Test

    Time frame: 6 months

    Functional assessment is a process that allows for the identification of disability. The data from the 5 Times Sit to Stand Test is used to calculate the duration it took to complete the test (unit: s).

Secondary outcomes

  1. Kinematic variables: Joint angles

    Time frame: 6 months

    A motion capture system is used to measure the joint kinematics. The data is used to calculate joint angles (unit: degree).

  2. Kinetic variables

    Time frame: 6 months

    A motion capture system is used to measure the joint kinetics. The data is used to calculate joint moments (unit: Nm)

Study contacts

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

Wei-Li Hsu, Ph.D.

CONTACT

[email protected]

886-2-3366-8127

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Digital Health for Aging: A Multimodal AI-Based Smart Assessment and Rehabilitation Training System for Lumbar Degeneration

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 21, 2025
Registry last updated
Aug 21, 2025

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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