Degenerative Lumbar Spine DiseasesNCT05425680
Remote Intelligent Interactive Virtual Reality Assessment in Patients With Degenerative Lumbar Spine Diseases
A study testing Core muscle training in people with Degenerative Lumbar Spine Diseases, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Degenerative Lumbar Spine Diseases
- What is being tested?
- Core muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 2 sitesTaiwan
- Study dates
- 15 Apr 2021to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- able to stand and walk for 5 minutes independently
- aged between 50 and 80 years
- received a diagnosis of DLSD based on imaging
Who cannot join
- neurological disorder such as stroke or spinal cord injury
- metabolic disease such as diabetes mellitus
- vestibular disease such as Meniere's disease.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
National Taiwan University Hospital or Movement Science Lab of National Taiwan University
Taipei, Taipei, 100
National Taiwan University Hospital
Taipei, 100
About this study
Official title: Clinical Effectiveness and Biomechanics Study for Remote Intelligent Interactive Virtual Reality Assessment and Rehabilitation 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.
Read the detailed description
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.
- Conditions
- Degenerative Lumbar Spine Diseases
- Being tested
- Core muscle training
- Keywords
- degenerative lumbar spine disease, virtual reality, telehealth, real-time detection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core muscle trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Core muscle training | Experimental | specific rehabilitation exercise for improving functional movements Receives: Other: Core muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
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).
Measured: 6 months
Functional assessment: Duration
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).
Measured: 6 months
Postural balance
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)
Measured: 6 months
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).
Measured: 6 months
Kinematic variables: Center of mass
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).
Measured: 6 months
Kinetic variables
A motion capture system is used to measure the joint kinetics. The data is used to calculate joint moments (unit: Nm)
Measured: 6 months
Muscle activities
Electromyography is a technique for evaluating and recording muscle activity. The data from electromyography is used to calculate a normalized value (unit: ratio).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start15 Apr 2021
- Primary completion15 Jul 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Lumbar Spine DiseasesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Li Hsu, Ph.D., Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425680
- Sponsor's protocol ID
- 202201047RINC
- Status last verified
- Jul 2025
- First submitted
- 13 Jun 2022
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness and Biomechanics Study for Remote Intelligent Interactive Virtual Reality Assessment and Rehabilitation in Patients With Degenerative Lumbar Spine Diseases
- ClinicalTrials.gov ID
- NCT05425680
- Acronym / sponsor ID
- 202201047RINC
- Conditions
- Degenerative Lumbar Spine Diseases
- Keywords
- degenerative lumbar spine disease, virtual reality, telehealth, real-time detection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Core muscle training | Experimental | Other: Core muscle trainingspecific rehabilitation exercise for improving functional movements |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- able to stand and walk for 5 minutes independently
- aged between 50 and 80 years
- received a diagnosis of DLSD based on imaging
Key exclusion criteria (3 listed)
- neurological disorder such as stroke or spinal cord injury
- metabolic disease such as diabetes mellitus
- vestibular disease such as Meniere's disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core muscle trainingCombining 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. | Other | Core muscle training |
Primary outcome
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).
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).
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).
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)
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).
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).
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)
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei-Li Hsu, Ph.D. principal investigator
National Taiwan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core muscle training in people with Degenerative Lumbar Spine Diseases, run by National Taiwan University Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional assessment: Walking speed (time frame: 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.