Wearable Flexible Sensors for Spinal Motion Monitoring

NCT06974721 | Not Yet Recruiting

• 1 other identifier: PekingUTH20250325
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (1)

• Limb Motor Function

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• Obesity (BMI\>30)
• Inability to complete functional assessments due to physical condition or other reasons;
• Comorbid neuromuscular disorders

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Xi'an Jiaotong University: collaborator

Related Publications (4)

• 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.

  PMID: 35271152 BACKGROUND

• Han 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.

  PMID: 36196076 BACKGROUND

• Li 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.

  PMID: 34366759 BACKGROUND

• Hodges 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.

  PMID: 34542672 BACKGROUND

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Weishi Li

CONTACT

+8615701206146; hangengyu@pku.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 16, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-03