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临床试验/NCT03316248
NCT03316248已完成不适用

Investigation of the Effect of Visual Feedback on Function, Stability and Quality of Life in Individuals With Transtibial Amputation

Hacettepe University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年1月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Prosthetic Weight bearing

研究概览

简要总结

This study was conducted to examine the effect of visual feedback on function, stability and quality of life in transtibial amputees. A total of 24 subjects who had unilateral transtibial amputations, used prosthesis with total surface bearing socket (TSB) for at least 1 year and volunteered to participate in the study were included. Before and after Treatment subjects were evaluated with "LASAR Posture" for prosthetic weight bearing (PWB), "Berg Balance Scale (BBS)" and "Timed Up& Go Test (TUG)" for balance and functional mobility, "2-Minute-Walk-Test (2MWT)" for physical performance, "Satisfaction with the Prosthesis Questionnaire (SATPRO)" for prosthetic pleasure and "Nottingham Health Profile (NHP)" for health- related quality of life. Participants were randomly divided into two equal groups as study and control groups. After the evaluations the same exercises; PWB exercises, balance exercises, anteroposterior and lateral weight shifting, obstacle course, walking on different grounds were applied to the the study group with visual feedback methods and control group.

详细描述

Inclusion criteria:

  1. had transtibial amputation
  2. >18 years old
  3. had total surface bearing socket at least one year

Outcome measures:

  • Prosthetic weight bearing
  • Berg Balance Scale
  • Timed up &go Test
  • 2 Minute Walk Test
  • Satisfaction of prosthesis questionnare
  • Nottingham health profile

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
None

入排标准

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

入选标准

  • •had unilateral transtibial amputations,
  • •used prosthesis with total surface bearing socket (TSB) for at least 1 year
  • •volunteered to participate in the study

排除标准

  • •had any neurological disorders
  • •had any cognitive problems

研究组 & 干预措施

visual feedback

Experimental

participants in the experimental group were applied usual prosthetic rehabilitation with visual feedback methods. 9 sessions for three days were applied.

干预措施: visual feedback (Other)

Usual prosthetic rehabilitation

Active Comparator

participants in the control group were applied usual prosthetic rehabilitation. 9 sessions for three days were applied.

干预措施: usual prosthetic rehabilitation (Other)

结局指标

主要结局

Prosthetic Weight bearing

时间窗: 3 minutes

minimal (Min WB) and maximal (Max WB) values were visually recorded on the amputated side for three consecutive minutes. The average weight bearing on the amputated side (Ml) was calculated by dividing the sum of maximal and minimal weight bearing values by two. The percentage of total body weight (TBW) borne through the amputated limb was then determined using the formula: (Ml/TBW) x 100

次要结局

未报告次要终点

研究者

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

Elif Kırdı

Research Assistant

Hacettepe University

研究点 (1)

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