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临床试验/NCT03872193
NCT03872193已完成不适用

Effects of Virtual Reality on Transtibial Amputation Ouality of Life,Performance, Balance,Prothesis Adaptation and Gait Outcomes

Hacettepe University0 个研究点目标入组 20 人开始时间: 2016年7月10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
20
主要终点
Performance Test

研究概览

简要总结

The aim of this study is to compare the effects of virtual reality applications on quality of life, performance, balance, prosthesis adaptation and gait parameters in individuals with transtibial amputation. 20 Transtibial amputee were included in study. All participants were using transtibial prothesis with active vacuum system at least 1 year. Participants were divided into two groups. While a group of virtual reality applications were being performed additionally standart physiotherapy, only standard physiotherapy methods were applied in the second group. Balance and gait practices were performed for each group. Individuals were treated for 3 days a week for 4 weeks, and individuals were evaluated before and after treatment. Individuals were evaluated for quality of life, performance, balance, prosthesis adaptation and time-distance parameters of walking.

详细描述

The aim of this study is to compare the effects of virtual reality applications on quality of life, performance, balance, prosthesis adaptation and gait parameters in individuals with transtibial amputation.20 transtibial amputee with 36 mean age were included in study. All participants were using transtibial prothesis with active vacuum system at least 1 year. Participants were divided into two groups. While a group of virtual reality applications were being performed, standard physiotherapy methods were applied in the second group. Balance and gait practices were performed for each group. Individuals were treated for 3 days a week for 4 weeks, and individuals were evaluated before and after treatment. Individuals were evaluated for quality of life, performance, balance, prosthesis adaptation and time-distance parameters of walking.

For this purpose, SF-36 Questionnaire, 6-minute walking test, one leg rest time, Trinity Amputation and Prosthetic Experience Scale, wearable biometric device and footprint method were utilized. There was a statistically significant difference between the two groups in pre-treatment and post-treatment performance, balance and gait parameters in the groups of individuals (p <0.05). The quality of life pain parameter was statistically decline in the group receiving virtual reality (p<0.05). On the other hand, significant differences in the quality of life and prosthesis adaptation of the individuals were not found between the groups (p> 0.05). The results of this study showed that virtual reality practices and standard physiotherapy methods are effective on performance, balance and walking in transtibial amputee rehabilitation. It is thought that it will be important to perform virtual reality applications in amputee rehabilitation separately in both methods, in addition to standard physiotherapy methods, to include in rehabilitation process, to bring an ability of alternative application to professionals working in this area and to work about amputees with using different suspension systems and with different amputation levels.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •transtibial and unilateral amputation
  • •At least 1 year prothesis usage, 18- 65 year age,
  • •At least 15 min independent walking ability,
  • •Stabile stump volume,
  • •Standart stump lentgh,
  • •Enough kognition for evaluation and tests.

排除标准

  • •walking and other activities to prevent; shortness of muscle, limitation of joint motion and phantom pain in stump, presence of any discomfort or systemic health problem that may affect the gait outside the amputation
  • •presence of visual problems to prevent participation in virtual reality applications,
  • •use of walking aids

研究组 & 干预措施

Physio Therapy

Experimental

We intervention this group some routine exercises. They had balance exercises, gait training,incline surface gait,bloked surface gait training and recreational activities. Extremity strengthenin exercises,balance exercises and increasing endurance are applied for this amputees.

干预措施: Exercise (Other)

Virtual Reality

Experimental

This group had physical therapy program plus virtual reality exercises. They had balance exercises, gait training,incline surface gait,bloked surface gait training and recreational activities. Extremity strengthenin exercises,balance exercises and increasing endurance are applied for this amputees. And virtual reality exercises were done for this group. Skiing,kayak, football,rafting and jumping activities were done in this exerciese.

干预措施: Exercise (Other)

结局指标

主要结局

Performance Test

时间窗: 6 minute

6 minute walk test,higher values represent a better

Gait Parameters

时间窗: 6 minute

Wearable Biometric Device

Quality of Life measured of individuals: SF-36 Scale

时间窗: 10 minute

SF-36 Quality of Life Scale, higher values represent a better

Balance Test

时间窗: 5 minute

Single Leg Balance Test,higher values represent a better

Prothesis Satisfaction: Trinity Amputation Prothesis Experience Scale

时间窗: 5 minute

Trinity Amputation Prothesis Experience Scale; 5 point likert scale,5-75 point, activity limitation,physicosocial adaptation,prothesis satisfaction

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

Fatih Erbahceci

Clinical Professor

Hacettepe University

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