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临床试验/NCT02031835
NCT02031835已完成不适用

Body Weight Supported Treadmill Training as Physical Therapy Treatment to Spinal Cord Injury Patients

University of Ioannina1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
WISCI II

研究概览

简要总结

The purpose of this current prospective study is to assess the effects of body weight support treadmill training (BWSTT) in individuals with spinal cord injury (SCI). Training intervention aim at improving: quality of life, walking capability, spasticity, functions in every day life, bone mass density and related hematological factors. The examination consisted of (1) neurological classification by ASIA standard neurological classification of spinal cord injury working sheet, (2) spasticity evaluation of lower limbs by Modified Ashworth Scale, (3) walking independence evaluation by Walking Index for Spinal Cord Injury II (WISCI II), (4) patient's quality of life perspective by World Health Quality of Life- BREF (WHOQOL-BREF), (5) the functional status by 10-item Modified Barthel Index, (6) bone mass density (BMD) by Dual-energy X-ray absorptiometry (DXA) scan, (7) body tissue consistency by full body DXA scan, (8) skeletal system health associated blood factors (calcitonin, osteocalcin, 25 OH vitamin D, 1,25- (OH)2 vitamin D, ostase and parathyroid hormone) by hematological tests. The results will be collected and evaluated using statistical software (i.e. SPSS).

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
8 Years 至 88 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASIA classification B, C or D
  • clinical stable

排除标准

  • unstable cardiac conditions
  • autonomic dysreflexia
  • significant musculoskeletal problems in lower extremities other than SCI
  • Parkinson's disease

结局指标

主要结局

WISCI II

时间窗: At the time of Admittance to the rehabilitation department (at baseline) and after six weeks

Change of walking independence at six weeks

次要结局

  • WHOQOL-BREF(At the time of Admittance to the rehabilitation department (at baseline) and after six weeks)
  • 10-item Modified Barthel Index(At the time of Admittance to the rehabilitation department (at baseline) and after six weeks)
  • DXA scan(At the time of Admittance to the rehabilitation department (at baseline) and after six weeks)
  • ASIA standard neurological classification for spinal cord injury patients working sheet(At the time of Admittance to the rehabilitation department (at baseline) and after six weeks)
  • Full Body DXA scan(At the time of Admittance to the rehabilitation department (at baseline) and after six weeks)
  • Modified Ashworth scale(At the time of Admittance to the rehabilitation department (at baseline) and after six weeks)
  • Hematological analysis(At the time of Admittance to the rehabilitation department (at baseline) and after six weeks)

研究者

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

Avraam Ploumis

Principal Invastigator

University of Ioannina

研究点 (1)

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