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Completed

NCT Number: NCT05425680

Remote Intelligent Interactive Virtual Reality Assessment in Patients With Degenerative Lumbar Spine Diseases

This study will combine virtual reality (VR) technology with machine learning to focus on functional movement. Patients' symptoms will be evaluated, and exercise instruction with real-time feedback will be provided. The goals of this research are to: (1) develop a waist digital sensor for real-time monitoring as an evaluation tool, (2) apply a real-time monitoring system in conjunction with virtual reality for telerehabilitation, and (3) develop the standard model.

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Key information

Conditions

Degenerative Lumbar Spine Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital or Movement Science Lab of National Taiwan University, Taipei, Taiwan

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About this study

The remote assessment and training in this study can assist patients obtaining physical therapy care at home. It is suitable for patients who avoid going to the hospital due to the epidemic, and solve the problem of long-term treatment. The outcomes will provide DLSD patients tele-rehabilitation platform and system, help medical personnel to treat patients more effectively in the future, and reduce the burden of medical costs on close ones.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • able to stand and walk for 5 minutes independently
  • aged between 50 and 80 years
  • received a diagnosis of DLSD based on imaging

Exclusion criteria

  • neurological disorder such as stroke or spinal cord injury
  • metabolic disease such as diabetes mellitus
  • vestibular disease such as Meniere's disease.

Treatment and study plan

Core muscle training

Other

Combining virtual reality technology and waist wearable sensors, training the pelvis and lumbar spine movements as the main training goal, it is estimated that two 1-hour training sessions per week, a total of 6 weeks of training, to improve the core muscle of patients with lumbar degenerative diseases muscle strength.

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: Duration

    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 calculate the duration it took to complete the test (unit: s).

  4. Postural balance

    Time frame: 6 months

    he postural balance measurements are performed by using a inertial sensor. The data from the inertial sensor is used to calculate the 95% confidence ellipse area (unit: cm^2)

  5. 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).

  6. Kinematic variables: Center of mass

    Time frame: 6 months

    A motion capture system is used to measure the displacement of the center of mass. The data is used to calculate the displacement of the center of mass (unit: cm).

  7. 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)

  8. Muscle activities

    Time frame: 6 months

    Electromyography is a technique for evaluating and recording muscle activity. The data from electromyography is used to calculate a normalized value (unit: ratio).

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Clinical Effectiveness and Biomechanics Study for Remote Intelligent Interactive Virtual Reality Assessment and Rehabilitation in Patients With Degenerative Lumbar Spine Diseases

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 21, 2022
Registry last updated
Jul 28, 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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