跳至主要内容
临床试验/NCT05010135
NCT05010135Unknown不适用

Evaluation of Balance and Gait Weight Distribution in Patients With Vertebral Column Fractures

Tung Wah College1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年1月25日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
Gait weight distribution (measure by the Zebris Rehabwalk machine to show the force in Newton)

研究概览

简要总结

Vertebral column fracture presents a significant warning of subsequent osteoporotic fracture and frequent falls. The presence of an osteoporotic vertebral fracture is also a predictor of further risk of vertebral and other osteoporotic fractures. This study provides balance assessment and gait evaluation for subjects with a known vertebral fracture.

Subjects are the known cases of vertebral fracture living in the community. They will be assessed for their balance and gait weight distribution by the TechnoBody for their balance ability, and the Zebris Gait System for the gait weight distribution. The Humac Norm for the lower limb muscle strength.

详细描述

This study evaluates the balance and weight distribution in walking gait in subjects with vertebral column fracture, comparing with the healthy subjects.

Study Objectives:

  1. To evaluate the balance and gait weight distribution of the vertebral fracture patients.
  2. To analyze the association between balance and gait weight distribution with fall risks in patients with stable vertebral fractures.
  3. To construct a community fall prevention protocol.

Methodology:

Subjects:80 ambulatory subjects with a history of vertebral fracture, aged 60 and above, will be recruited from the community.

研究设计

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

入排标准

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

入选标准

  • All subjects are aged 60 or above with a history of vertebral fracture, and able to walk without assistance;
  • Not received bilateral hip replacement and spinal surgery;
  • No known malignance at time of enrollment;
  • Able to attend Tung Wah College for examination and assessment, understand and sign the consent form.

排除标准

  • Unable to attend the research center for receiving examination and tests;
  • Unable to give consent;
  • Diseases such as stroke and Parkinson's Disease that adversely affect the balance and gait weight distribution;
  • Bed bound or wheel-chair bound patients.

结局指标

主要结局

Gait weight distribution (measure by the Zebris Rehabwalk machine to show the force in Newton)

时间窗: Up to 24 weeks

compare between the 2 groups

Balance (measure by the TechnoBody machine to show the amplitude of body displacement from the centre)

时间窗: Up to 24 weeks

compare between the 2 groups

次要结局

  • Positional senses (measure by the position sensor attached on the feet, legs, thighs, lumber spine, thoracic spine and the cervical spine to show the body displacement in angle degrees).(Up to 24 weeks)
  • Quality of Life evaluation (measure by the SF-12 questionnaire)(Up to 24 weeks)
  • Muscle strength (measure by the Humac Norm machine to evaluate the Quadriceps and Hamstrings strength in Peak Torque, N)(Up to 24 weeks)
  • Low Back Pain (measure by the Oswestry Disability Index and Roland Morris Disability Questionnaire)(Up to 24 weeks)

研究者

发起方
Tung Wah College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Anthony Kwok

Associate Professor

Tung Wah College

研究点 (1)

Loading locations...

相似试验