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临床试验/NCT03254797
NCT03254797已完成不适用

Effects of Stepping Training With 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 44 人开始时间: 2017年8月20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
44
试验地点
2
主要终点
Change of walking stability using Timed up and go test [TUGT]

研究概览

简要总结

Does a 4-week stepping training program with or without external feedback clinically change functional ability and reduce risk of fall of ambulatory patients with iSCI?

Are there significant differences between 4-weeks stepping training with or without external feedback in ambulatory patients with iSCI?

详细描述

To compare effects of 4-week stepping training with or without external feedback on functional ability and incidence of falls in ambulatory patients with iSCI (between-group comparison).

To compare the change of functional ability in a group of 4-week stepping training with or without the utility of external feedback (within-group comparison).

研究设计

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

入排标准

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

入选标准

  • Independent ambulatory patients with iSCI
  • Non-traumatic or traumatic causes
  • 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 stability using Timed up and go test [TUGT]

时间窗: prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the 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)(prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program)
  • Change of walking endurance using 6 minute walk test (6MWT)(prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program)
  • Change of lower limb muscle strength using Five times sit-to-stand [FTSST](prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the 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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