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临床试验/NCT04735484
NCT04735484Unknown不适用

Measuring Dynamic Spinal Balance With Wearable Activity Trackers. A Case Control Study.

University College, London0 个研究点目标入组 24 人开始时间: 2021年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
24
主要终点
Margin of stability

研究概览

简要总结

Observational case-control study to see if the Margin of Stability and Dynamic Postural Stability (measured using a motion capture gait laboratory and wearable device, respectively) are different in children with Adolescent Idiopathic Scoliosis and matched controls. Participants will walk across level ground and on a treadmill once for data collection and no follow-up is required.

详细描述

The goal of this observational case-control study is to validate the Margin of Stability (MoS) and Dynamic Postural Stability (DPS) measures using a motion capture gait laboratory and wearable device in patients with Adolescent Idiopathic Scoliosis (AIS).

These measures will provide a consultant with objective data about a patient's movement and balance that the consultant and other healthcare professionals can use to infer about their spinal deformity progression or improvement. This research is an early step for working towards providing a distance medicine, non-invasive outcome measure that can be used alongside or in the absence of current clinical measures and radiography. Use of this data could reduce the frequency with which radiographs are required and so reduce the impact of radiation exposure. This wearable device could complement and improve upon existing outcome measures in the treatment of spinal deformity, reduce the need for radiographs and ameliorate the need for distance patient monitoring methods. A motion capture gait laboratory will be used as the gold-standard comparison.

A pilot study has been carried out on healthy participants with a simulated spinal deformity in a kinematic gait laboratory and using the wearable device, which showed altered balance in the simulated scoliosis group compared to controls.

The aim of this project is to:

  1. To see if there's a difference in MoS and DPS between children with AIS and controls,
  2. To see if a difference can be detected using motion capture gait analysis and a wearable device,
  3. To see how similar results from the wearable device are to the motion capture gait laboratory,
  4. To test the ability of the wearable device to measure a scalable difference between radiographic curve magnitude in patients with AIS.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosed with Adolescent Idiopathic Scoliosis
  • Single, right-sided thoracic, left-sided thoraco-lumbar or left-sided lumbar curve
  • <= 1cm leg length discrepancy
  • Diagnostic radiographs of curvature within 3 months
  • Ability to walk without assistance
  • Willing and able to comply with clinical study visit requirements
  • Control Inclusion Criteria:
  • Ability to walk without assistance
  • Willing and able to comply with clinical study visit requirements
  • Case & Control

排除标准

  • Previous spinal surgery or joint replacement
  • Syndromic, neuromuscular or pathologic condition
  • Neurological, vestibular, somatosensory or orthopaedic comorbidities
  • Pregnancy
  • Poor understanding of written and/or spoken English

结局指标

主要结局

Margin of stability

时间窗: Data collection appointment 1 - approx. 90 minutes

次要结局

  • Correlation between Margin of Stability and radiographic Cobb angle(Data collection appointment 1 - approx. 90 minutes)
  • Correlation between Dynamic Postural Stability and radiographic Cobb angle(Data collection appointment 1 - approx. 90 minutes)
  • Dynamic Postural Stability(Data collection appointment 1 - approx. 90 minutes)

研究者

申办方类型
Other
责任方
Sponsor

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