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RecruitingNCT07133724Updated Aug 21, 2025

Digital Health for Lumbar Degeneration

An interventional study of AI-Based Smart Assessment and Rehabilitation Training in Degenerative Lumbar Spine Diseases, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-21.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
50 Years to 80 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Degenerative Lumbar Spine Diseases

Keywords

  • degenerative lumbar spine disease
  • real-time detection
  • artificial Intelligence
03

In context

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 568 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Presence of systemic joint diseases such as ankylosing spondylitis, rheumatoid arthritis, or multiple sclerosis, which may significantly affect lumbar mobility and gait patterns.
  2. Central nervous system disorders (e.g., spinal cord injury, stroke, or Parkinson's disease) that may influence gait and motor control.
  3. Vestibular system disorders, to avoid balance abnormalities interfering with gait testing.
  4. History of spinal or lower limb surgery, as postoperative changes may affect the accuracy of gait data.
  5. Inability to communicate or follow instructions.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    AI-Based Smart Assessment and Rehabilitation Training

    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.

    Other: AI-Based Smart Assessment and Rehabilitation Training

Interventions

  • OtherAI-Based Smart Assessment and Rehabilitation Training

    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.

06

What researchers measure

Primary outcomes

  1. Functional assessment: Walking speed

    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).

    Time frame: 6 months

  2. Functional assessment: Walking distance

    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).

    Time frame: 6 months

  3. Functional assessment: 5 Times Sit to Stand Test

    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).

    Time frame: 6 months

Secondary outcomes

  1. Kinematic variables: Joint angles

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

    Time frame: 6 months

  2. Kinetic variables

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

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07133724
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Aug 21, 2025
Start date
Aug 1, 2025
Primary completion
Jul 31, 2028 (estimated)
Completion
Jul 31, 2028 (estimated)
Last update
Aug 21, 2025

Study contacts

Wei-Li Hsu, Ph.D.
Contact
wlhsu@ntu.edu.tw
886-2-3366-8127

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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