Spine DiseaseNCT06974721
Wearable Flexible Sensors for Spinal Motion Monitoring
An observational study of Spine Disease, run by Peking University Third Hospital.
Trial summary
With the deepening of societal aging, degenerative spinal diseases have become increasingly prevalent in China and are one of the leading causes of disability among middle-aged and elderly populations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spine Disease
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 Dec 2027
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We are recruiting patients with spinal diseases, including cervical spondylosis with hand dysfunction, kyphosis/spinal imbalance, scoliosis (Cobb angle 20°-50°), and lumbar spondylolisthesis (>3mm dynamic slip).
Who may be able to join
- Clinical diagnosis of Spinal Cord Injury
- Clinical diagnosis of cervical spondylotic myelopathy with Impaired Hand Function
- Clinical diagnosis of Kyphosis
- Clinical diagnosis of Spinal Imbalance
- Clinical diagnosis of Scoliosis Patients
- Clinical diagnosis of Lumbar Spondylolisthesis Patients
Who cannot join
- Obesity (BMI>30)
- Inability to complete functional assessments due to physical condition or other reasons;
- Comorbid neuromuscular disorders
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Wearable Flexible Sensors for Spinal Motion Monitoring in Spinal Diseases
With the deepening of societal aging, degenerative spinal diseases have become increasingly prevalent in China and are one of the leading causes of disability among middle-aged and elderly populations. Current musculoskeletal assessment methods primarily focus on imaging rather than functional evaluation, and emphasize static over dynamic analysis, failing to capture the daily functional state of the musculoskeletal system. This limitation hinders a deeper understanding of functional patterns and their role in the progression of degenerative spinal diseases. Therefore, there is an urgent need to develop precise and dynamic functional assessment methods that overcome the constraints of time and space in measurement. This project adopts a dynamic perspective of the musculoskeletal system, developing a wearable monitoring approach based on flexible sensors to assess limb and spinal motion. The method will be validated against traditional imaging techniques such as X-ray and ultrasound, laying the foundation for investigating the pathogenesis of degenerative spinal diseases. This research aligns with China's strategic initiatives and practical needs in addressing the challenges of an aging population.
- Conditions
- Spine Disease
- Keywords
- flexible sensor, spine disease
- Medical subject headings
- Spinal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor and Stabilizing Function of the Spine
The assessment of spinal stability at the baseline involves evaluating flexion-extension mobility in the sagittal plane, lateral bending capability in the coronal plane, and detecting relative displacement between vertebral segments during three-dimensional motion.
Measured: Baseline
Secondary outcomes (1)
Limb Motor Function
Assessment of Limb Muscle Strength Function Using Dynamometer Grip Strength Tests and Hand Function Scoring at the baseline.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spine DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xi'an Jiaotong University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974721
- Sponsor's protocol ID
- PekingUTH20250325
- Status last verified
- Mar 2025
- First submitted
- 29 Apr 2025
- Last updated
- 16 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang Y, Zheng L, Yang J, Wang S. A Grip Strength Estimation Method Using a Novel Flexible Sensor under Different Wrist Angles. Sensors (Basel). 2022 Mar 4;22(5):2002. doi: 10.3390/s22052002.
PubMed 35271152Han G, Zhou S, Wang W, Li W, Qiu W, Li X, Fan X, Li W. Correlations between paraspinal extensor muscle endurance and clinical outcomes in preoperative LSS patients and clinical value of an endurance classification. J Orthop Translat. 2022 Sep 20;35:81-86. doi: 10.1016/j.jot.2022.08.005. eCollection 2022 Jul.
PubMed 36196076Li Z, Zhang S, Chen Y, Ling H, Zhao L, Luo G, Wang X, Hartel MC, Liu H, Xue Y, Haghniaz R, Lee K, Sun W, Kim H, Lee J, Zhao Y, Zhao Y, Emaminejad S, Ahadian S, Ashammakhi N, Dokmeci MR, Jiang Z, Khademhosseini A. Gelatin methacryloyl-based tactile sensors for medical wearables. Adv Funct Mater. 2020 Dec 1;30(49):2003601. doi: 10.1002/adfm.202003601. Epub 2020 Sep 6.
PubMed 34366759Hodges PW, Bailey JF, Fortin M, Battie MC. Paraspinal muscle imaging measurements for common spinal disorders: review and consensus-based recommendations from the ISSLS degenerative spinal phenotypes group. Eur Spine J. 2021 Dec;30(12):3428-3441. doi: 10.1007/s00586-021-06990-2. Epub 2021 Sep 20.
PubMed 34542672
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Flexible Sensors for Spinal Motion Monitoring in Spinal Diseases
- ClinicalTrials.gov ID
- NCT06974721
- Acronym / sponsor ID
- PekingUTH20250325
- Conditions
- Spine Disease
- Keywords
- flexible sensor, spine disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Xi'an Jiaotong University
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 16 May 2025 (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.
With the deepening of societal aging, degenerative spinal diseases have become increasingly prevalent in China and are one of the leading causes of disability among middle-aged and elderly populations. Current musculoskeletal assessment methods primarily focus on imaging rather than functional evaluation, and emphasize static over dynamic analysis, failing to capture the daily functional state of the musculoskeletal system. This limitation hinders a deeper understanding of functional patterns and their role in the progression of degenerative spinal diseases. Therefore, there is an urgent need to develop precise and dynamic functional assessment methods that overcome the constraints of time and space in measurement. This project adopts a dynamic perspective of the musculoskeletal system, developing a wearable monitoring approach based on flexible sensors to assess limb and spinal motion. The method will be validated against traditional imaging techniques such as X-ray and ultrasound, laying the foundation for investigating the pathogenesis of degenerative spinal diseases. This research aligns with China's strategic initiatives and practical needs in addressing the challenges of an aging population.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We are recruiting patients with spinal diseases, including cervical spondylosis with hand dysfunction, kyphosis/spinal imbalance, scoliosis (Cobb angle 20°-50°), and lumbar spondylolisthesis (>3mm dynamic slip).
Key inclusion criteria (6 listed)
- Clinical diagnosis of Spinal Cord Injury
- Clinical diagnosis of cervical spondylotic myelopathy with Impaired Hand Function
- Clinical diagnosis of Kyphosis
- Clinical diagnosis of Spinal Imbalance
- Clinical diagnosis of Scoliosis Patients
Key exclusion criteria (3 listed)
- Obesity (BMI>30)
- Inability to complete functional assessments due to physical condition or other reasons;
- Comorbid neuromuscular disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Motor and Stabilizing Function of the Spine
Time frame: Baseline
The assessment of spinal stability at the baseline involves evaluating flexion-extension mobility in the sagittal plane, lateral bending capability in the coronal plane, and detecting relative displacement between vertebral segments during three-dimensional motion.
1 secondary outcome
Limb Motor Function
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Results publication: PubMed 35271152Wang Y, Zheng L, Yang J, Wang S. A Grip Strength Estimation Method Using a Novel Flexible Sensor under Different Wrist Angles. Sensors (Basel). 2022 Mar 4;22(5):2002. doi: 10.3390/s22052002.
- Results publication: PubMed 36196076Han G, Zhou S, Wang W, Li W, Qiu W, Li X, Fan X, Li W. Correlations between paraspinal extensor muscle endurance and clinical outcomes in preoperative LSS patients and clinical value of an endurance classification. J Orthop Translat. 2022 Sep 20;35:81-86. doi: 10.1016/j.jot.2022.08.005. eCollection 2022 Jul.
- Results publication: PubMed 34366759Li Z, Zhang S, Chen Y, Ling H, Zhao L, Luo G, Wang X, Hartel MC, Liu H, Xue Y, Haghniaz R, Lee K, Sun W, Kim H, Lee J, Zhao Y, Zhao Y, Emaminejad S, Ahadian S, Ashammakhi N, Dokmeci MR, Jiang Z, Khademhosseini A. Gelatin methacryloyl-based tactile sensors for medical wearables. Adv Funct Mater. 2020 Dec 1;30(49):2003601. doi: 10.1002/adfm.202003601. Epub 2020 Sep 6.
- Results publication: PubMed 34542672Hodges PW, Bailey JF, Fortin M, Battie MC. Paraspinal muscle imaging measurements for common spinal disorders: review and consensus-based recommendations from the ISSLS degenerative spinal phenotypes group. Eur Spine J. 2021 Dec;30(12):3428-3441. doi: 10.1007/s00586-021-06990-2. Epub 2021 Sep 20.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Spine Disease, run by Peking University Third Hospital.
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 6 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: opening soon, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weishi Li (+8615701206146, hangengyu@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor and Stabilizing Function of the Spine (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06974721, which also lists 4 linked publications.
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 16 May 2025.