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临床试验/NCT01988220
NCT01988220已完成不适用

The Effects of Lower Extremity Sensory Retraining Treatment in Individuals With Post-stroke Sensory Impairment

Yocheved Laufer1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
Change in Timed Up and Go test

研究概览

简要总结

Background: It is estimated that 50%-85% of individuals post stroke demonstrate sensory deficits. Sensory impairments are often overlooked in the therapeutic setting, although they lead to slower motor recovery.

Working hypothesis: The overall goal of this study is to examine the effectiveness of a sensory discrimination reeducation oriented therapeutic program to the lower limb of stroke patients with sensory impairments. We assume that subjects to both groups will make progress, which will be more significant in the experimental group.

Methods: Study population and design: Sixty individuals with chronic sensory impairment following a stroke will be recruited. Patients will be randomly assigned to sensory retraining treatment or to sensory stimulation treatment. Treatment will consist of ten 45 minute long intervention sessions, carried out within a 6 weeks period, and a home exercise program. The person conducting the assessments will be blind to the treatment allocation of the subjects. Outcome measures: The efficacy of the intervention will be determined in relation to the International Classification of Functionality (ICF) developed by the World Health Organization and will include assessments at the three domains defined by this model: 1. Body structure and function - determined by measures of the sensory capacity of the lower more affected limb; 2. Activities - determined by measures of balance and gait; 3. Participation - determined by measures of well-being and social reintegration.

Two new outcome measures, for ankle and knee position sense and for texture discrimination of the foot, will be developed within this study. Data reliability measures on healthy population, and test - retest measures in post stroke population with be collected.

Intervention: The experimental group will be treated by a perception learning oriented protocol for sensory reeducation, to improve identification, localization and discrimination of sensory stimuli, including electrical stimulation, texture and hardness discrimination and position sense training. The control group will receive the same stimuli without the attentive learning and discriminating component.

Importance: Scientific proof and focused recommendations for a potent therapeutic method for the post-stroke population, allowing them better participation and quality of life.

Key words: Stroke, sensory impairment, perceptual learning, lower limb, clinical trial.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • post stroke
  • at least 6 months after stroke
  • with sensory deficits in study's screening tests

排除标准

  • other neurologic condition
  • peripheral neuropathy
  • pacemaker
  • hemispatial neglect

结局指标

主要结局

Change in Timed Up and Go test

时间窗: pre - up to a week before intervention, post - after 6 weeks, follow-up - 3 months after

Standing up from a chair, walking three meters, turning around and coming back to sitting. time is assessed.

次要结局

  • Von Frey monofilaments foot identification threshold(screening - one week before pretest, pre - up to one week before intervention, post - 6 weeks after, follow-up - 3 months after)

研究者

发起方
Yocheved Laufer
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yocheved Laufer

Chair, Physical Therapy Department

University of Haifa

研究点 (1)

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