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临床试验/NCT03875066
NCT03875066已完成不适用

Immediate Effects of Stepping Training With or Without External Feedback on Walking and Functional Ability in Ambulatory Patients With Spinal Cord Injury

Khon Kaen University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年4月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Change of walking balance using Timed up and go test [TUGT]

研究概览

简要总结

  • Does stepping training with or without external feedback change functional ability of ambulatory patients with iSCI immediately after training?
  • Are there significant differences between the immediate effects of stepping training with or without external feedback in ambulatory patients with iSCI?

详细描述

To compare immediate effects of stepping training with or without the utility of external feedback on functional ability relating to walking in ambulatory patients with iSCI (between-group comparison).

Secondary objective To compare immediate effects in a group of stepping training with or without the utility of external feedback on functional ability relating to walking in ambulatory patients with iSCI (within-group comparison).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Independent ambulatory patients with iSCI at a chronic stage (Post-injury time > 12 months)
  • Traumatic cause or non-progressive disease
  • Independent walking with or without assistive devices at least 17 meters (Functional Independence Measure Locomotor (FIM-L) scores 5-7)
  • Age at least 18 years
  • Body mass index (BMI) between 18.5 - 29.9 kg/m2.

排除标准

  • Any conditions or disorders that might affect ability to participate in the study and/or ambulatory ability of the subjects such as
  • Brain function disorders
  • Visual deficits that cannot be corrected using glasses or contact lens
  • Musculoskeletal pain (with an intensity of pain more than 5 out of 10 on a numerical rating pain scale)
  • Deformity of the musculoskeletal system
  • Unable to follow a command of the tests
  • Unstable medical conditions
  • Color blindness

结局指标

主要结局

Change of walking balance using Timed up and go test [TUGT]

时间窗: Baseline and immediately after complete one section training program

The test was designed to measure mobility and dynamic balance control related to walking. Subjects will be instructed to stand up from a standard chair, walk at a fastest and safe speed for 3 meters, turn around a traffic cone, walk back and sit down on the chair with or without a walking device. Then the average time required for the 3 trials will be recorded.

次要结局

  • Change of walking speed using 10 meter walk test (10MWT)(Baseline and immediately after complete one section training program)
  • Change of lower limb muscle strength using Five times sit-to-stand [FTSST](Baseline and immediately after complete one section training program)
  • Change of lower limb support ability [LLSA] on more and less affected legs(Baseline and immediately after complete one section training program)

研究者

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

Sugalya Amatachaya

Assoc. Prof. Dr.

Khon Kaen University

研究点 (2)

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