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临床试验/NCT02877030
NCT02877030已完成不适用

Sensorimotor Exercises in Virtual Reality Platform and Balance in Individuals With Human T-lymphotropic Virus

Pedreira, Érika, M.D.2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2017年4月2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
发起方
入组人数
42
试验地点
2
主要终点
Timed up and Go

研究概览

简要总结

Testing the effectiveness of an exercise protocol engines sensory performed through a virtual reality platform in individuals infected with HTLV-1

详细描述

Crossover randomized clinical trial to be conducted with people having a previous diagnosis of HTLV-1, they can remain in standing position without assistance. They will be excluded from those presenting amputation of the lower limbs, pregnancy, psychiatric disorders, rheumatic or orthopedic diseases, other neurological disorders associated and those that are experiencing difficulty in understanding the assessment tools used. They will also be recruited to a comparative group, healthy individuals, matched for sex, age and education level. It will be performed three assessments, before randomization, after 10 weeks and after 20 weeks, which will be evaluated in balance, functional mobility, gait and posture. The participants infected with HTLV-1, will be divided into two groups by random distribution, a group will begin the treatment protocol with video game immediately after the first evaluation and the other after ten weeks, with the crossing of the groups . Concealment of allocation will be guaranteed to the examiners who will have no contact with the physiotherapist who will apply the exercise protocol and the team member responsible for drawing. Patients will also be instructed to maintain confidentiality of the entry in the exercise program to other patients and examiners.

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 (Investigator)

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

入选标准

  • people having a previous diagnosis of HTLV-1, which can remain in standing position without assistance.

排除标准

  • amputation of the lower limbs, pregnancy, psychiatric disorders, rheumatic or orthopedic diseases, other neurological disorders associated and those that are experiencing difficulty in understanding the assessment tools used.

研究组 & 干预措施

Test control group

Experimental

Start the sensorimotor exercises protocol with video game immediately after the first evaluation

干预措施: Video game (Other)

Control test group

Active Comparator

Start of sensorimotor exercises with video game protocol after ten weeks

干预措施: Video game (Other)

comparison group

No Intervention

No intervention

结局指标

主要结局

Timed up and Go

时间窗: average 8 weeks

Functional mobility in patients with HTLV-1 undergoing rehabilitation with video game

Gait performance at CvMob (Software for movement analysis)

时间窗: an average 8 weeks

Gait performance in patients with HTLV-1 undergoing rehabilitation with video game

Posture analysis at CvMob (Software for movement analysis)

时间窗: average 8 weeks

Posture analysis in patients with HTLV-1 undergoing rehabilitation with video game

次要结局

  • Brief Pain Inventory (BPI)(average 8 weeks)
  • WHOQOL BRIEF(average 8 weeks)

研究者

发起方
Pedreira, Érika, M.D.
申办方类型
Indiv
责任方
Principal Investigator
主要研究者

Érika Pedreira

M.D.

Pedreira, Érika, M.D.

研究点 (2)

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