Clinical trial NCT06974721: Wearable Flexible Sensors for Spinal Motion Monitoring
Official title: Wearable Flexible Sensors for Spinal Motion Monitoring in Spinal Diseases
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Spine Disease
Keywords: flexible sensor
spine disease
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Xi'an Jiaotong University
First posted: 2025-05-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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).

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.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of Spinal Cord Injury
2. Clinical diagnosis of cervical spondylotic myelopathy with Impaired Hand Function
3. Clinical diagnosis of Kyphosis
4. Clinical diagnosis of Spinal Imbalance
5. Clinical diagnosis of Scoliosis Patients
6. Clinical diagnosis of Lumbar Spondylolisthesis Patients

Exclusion Criteria:

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

Primary outcomes:
measure: Motor and Stabilizing Function of the Spine
timeFrame: Baseline
Secondary outcomes:
measure: Limb Motor Function
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
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citation: 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.
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citation: 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.