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临床试验/NCT03974490
NCT03974490已完成不适用

Effect of Rhythmic Auditory Stimulation on Balance and Gait Parameters in Stroke Patients

Hospital Sociosanitari Mutuam Girona2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2019年4月1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
55
试验地点
2
主要终点
Gait

研究概览

简要总结

A rhythmic auditory stimulation intervention may be beneficial in order to improve movement parameters after stroke. Reviews argue that more randomized controlled trials with a control group are needed. Main objective: Evaluate the effect of a rhythmic auditory stimulation on the quality of balance and gait parameters in people with stroke. Methodology: quasi-experimental study. The study has been approved by the hospital ethics committee.

详细描述

A rhythmic auditory stimulation (RAS) intervention may be beneficial in order to improve the parameters of the post-stroke movement: increase of the speed of the walk, improvement in the width of the step with the affected side, improvement of the walking index dynamics (Dynamic Gait Index), improvement in cadence and improvement in the static balance.

Current systematic reviews argue that more randomized controlled trials with a control group are needed.

Main objective: To evaluate the effect of a rhythmic auditory stimulation on the quality of progress and balance in people with stroke.

Methodology: experimental group will be done between 2019 and 2020 and historical control group of the years 2017 and 2018. Experimental group will do 3 sessions in a week of RAS, and daily 2 hours of physiotherapy except of Sundays. Control group received 2 hours daily of physiotherapy, except Sundays.

The study has been approved by the hospital ethics committee.

研究设计

研究类型
Interventional
分配方式
Non 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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Had a stroke in the last 3 weeks
  • Rankin 3-4
  • Barthel before stroke: >85
  • Tinetti < 23

排除标准

  • Patient can walk independently (Functional Ambulation Category >3)
  • Global and/or mixed aphasia
  • Glasgow < 10
  • Mini-Mental State Examination < 24
  • Posterior cerebral artery stroke
  • Gait and/or balance disorders before stroke (parkinsons disease, neurodegenerative diseases)

结局指标

主要结局

Gait

时间窗: At baseline, 20 days and 40 days after baseline

Change in gait using the Timed Up\&Go Test

Balance

时间窗: At baseline, 20 days and 40 days after baseline

Change in balance using the Tinetti Test

Gait Functionality

时间窗: At baseline and 40 days after baseline

Change in gait functionality using the Functional Ambulatory Category

Gait parameters

时间窗: At baseline, 20 days after baseline and 40 days after baseline

Change in step length using a measure tape

次要结局

未报告次要终点

研究者

发起方
Hospital Sociosanitari Mutuam Girona
申办方类型
Other
责任方
Principal Investigator
主要研究者

Samira Gonzalez Hoelling

Principal Investigator, Physiotherapist

Hospital Sociosanitari Mutuam Girona

研究点 (2)

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