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临床试验/NCT04509310
NCT04509310Unknown不适用

Effectiveness of Active Bodysuits for Adult Degenerative Scoliosis

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年1月6日最近更新:
适应症

试验速览

阶段
不适用
入组人数
15
试验地点
1
主要终点
Body alignment

研究概览

简要总结

Adult degenerative (de novo) scoliosis (ADS) is a condition of the ageing population caused by degenerative changes without pre-existing spinal deformity. Pain is the most frequent problem, especially low back pain and radicular pain, and seriously affects the daily activities and health of ADS patients. The current treatment for ADS is not well defined. The main intervention for ADS treatment is surgical, but surgery is clearly not appropriate for every patient. Active bodysuits will be designed based on body alignment and pain management using special design components and incorporating active posture training from a biofeedback system. Back pain is often localized along the convexity of the curve, and passive support to the areas of pain, most likely in the lower trunk, hip and lower extremities, should be provided.

详细描述

The potential materials that can provide support are 3D printable rigid materials, semirigid foam padding, Velcro tape and stretchable wide waistbands. The 3D printable materials can be very versatile in terms of properties and can be further finished with an epoxy resin or thermoplastics. Different compositions and structures of knitted fabrics will be used in different areas of the proposed bodysuits to provide a close fit, high breathability and effective pain management due to extra support. The fastening system includes a magnetic zipper and pulley system that can be adjusted by pulling on knobs. The pulley system contains a microadjustable dial, super-strong lightweight lacing, and low friction lacing guides.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults diagnosed with degenerative scoliosis
  • Cobb's angle greater than 25 degrees
  • Chronic lower back pain
  • Limited mobility due to degenerative scoliosis

排除标准

  • Substantial cardiac, pulmonary, renal or metabolic disease
  • Neuromuscular scoliosis (e.g., spinal muscular atrophy, cerebral palsy, Parkinson's Disease, post-polio syndrome, Charcot Marie Tooth disease)
  • Spine tumor, infection or connective tissue disorder
  • Cognitively impaired or unable/unwilling to comply with follow-up
  • Past history of vertebroplasty or kyphoplasty of the thoracic or lumbar spine

结局指标

主要结局

Body alignment

时间窗: 9-12 months

Evaluation of kyphosis or lordosis in the sagittal plane

次要结局

  • Scoliosis Research Society Quality of Life Questionnaire(1 year)
  • Oswestry Disability Index(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Kenny Kwan

Clinical Assistant Professor

The University of Hong Kong

研究点 (1)

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