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临床试验/NCT04830319
NCT04830319已完成不适用

Therapeutic Effect of the Pilates Method in People With HAM/TSP: a Randomized Crossover Study

Pedreira, Érika, M.D.2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2018年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
2
主要终点
Functional Mobility

研究概览

简要总结

Individuals with HTLV-1 secondary myelopathy (HAM/TSP) may have motor and sensory alterations, which may result in reduced functional performance and consequent risk of falls. The aim of the study is to verify the therapeutic effect of a Pilates exercise program on functional performance and risk of falls, when compared to task-oriented training, of people with HAM / TSP. This is a randomized, crossover clinical trial performed with individuals with HAM / TSP who are attended at a referral center who is able to perform gait whether or not to use a walking aid. Amputees, with psychiatric disorders, rheumatic or orthopedic diseases and other associated neurological disorders, which could influence the balance and functional mobility, as well as pregnant women, were excluded. Participants will be submitted to the initial evaluation of functional mobility, balance, gait balance, fatigue, gait endurance, sphincter changes and questioned about the occurrence of falls in the last three months and will answer a semi-structured questionnaire about their conjugality. They will be allocated randomly to two groups. One will perform the Pilates Method protocol and the other task-oriented training. The first group, called test-control group (GTC), will initiate the protocol with exercises of the Pilates method; the control-test group (GCT) will initiate the task-oriented training protocol. A p <0.05 will be considered a statistically significant difference.

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 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • individuals with probable and/or defined diagnosis of HAM / TSP, according to WHO criteria, of both sexes, aged 18 to 64 years.

排除标准

  • individuals with lower limb amputation, pregnancy, psychiatric disorders, rheumatic or orthopedic diseases, other associated neurological disorders, and those who have difficulty understanding the assessment instruments.

结局指标

主要结局

Functional Mobility

时间窗: 3 minutes

Timed up and Go (TUG)

Gait Balance

时间窗: 10 minutes

Dynamic Gait Index (DGI)

Balance

时间窗: 20 minutes

Balance Evaluation Systems Test of dynamic balance (mini-BESTest)

次要结局

未报告次要终点

研究者

发起方
Pedreira, Érika, M.D.
申办方类型
Indiv
责任方
Sponsor

研究点 (2)

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