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临床试验/NCT03271463
NCT03271463已完成不适用

Lower Extremity Selective Voluntary Motor Control in Adults With Chronic Stroke: Comparing the SCALE Assessment to the Fugl-Meyer Assessment

University of Minnesota1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2018年8月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Selective Control Assessment of Lower Extremity (SCALE)

研究概览

简要总结

The purpose of this study is to compare the clinometric (psychometric) properties of the SCALE and FMA-LE assessments in adults after stroke. A second purpose is to determine how well each measure predicts walking speed using the 10 meter walk test.

详细描述

Selective voluntary motor control may be important in prognosticating future function in adults post stroke. It is therefore important to measure selective voluntary motor control using assessments that are valid, reliable and easy to perform and interpret. Current assessments are time consuming and complicated. Clinicians who work with patients post stroke will benefit from this research because they will have evidence supporting appropriate measurement of selective voluntary motor control. This evidence may inform their clinical decision making when working with patients. Patients who have survived a stroke will benefit because their therapists will be able to better measure their selective voluntary motor control which may one day lead to better prediction of functional outcomes and the selection of appropriate interventions.

The Fugl-Meyer assessment (FMA) is the "Gold Standard" for the assessment of individuals with brain injury, most commonly those surviving cerebrovascular accident (stroke). The full assessment is complicated and can take more than an hour to complete. Clinicians have limited time to perform a full evaluation of their patients, the FMA is just one part of this evaluation. The lower extremity selective voluntary motor control component of the FMA (FMA-LE) is difficult for clinicians who are not experts to perform and interpret. For these reasons, few practicing clinicians use the FMA. However, measuring selective voluntary motor control may be important for prognosticating patients' future functional level and their need for continued therapeutic interventions. The Selective Control Assessment of Lower Extremity (SCALE) was developed for use with children who have cerebral palsy (CP), a condition that in some ways presents similar to stroke. The SCALE has been validated and deemed reliable in the pediatric population with CP. This study aims to determine inter-rater and intra-rater reliability for the FMA-LE and the SCALE. In addition, scores on the SCALE will be compared to scores on the FMA-LE to determine concurrent validity. Finally the scores on the SCALE and FMA-LE will be compared to the time it takes for stroke survivors to walk 10-meters (10-meter walk test) to determine how well each measure predicts functional status (predictive validity).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults between 18 and 79 years of age who have sustained a chronic cerebrovascular accident (stroke) with known corticospinal tract damage
  • At least one year after onset
  • Ability to walk
  • Ability to understand and follow simple instructions
  • Written informed consent obtained from subject

排除标准

  • History of cerebellar infarct, traumatic brain injury, tumor, etc.
  • Rigidity, ataxia, or other Cerebellar or Basal Ganglia signs or symptoms.
  • Hospitalizations in the past 6 months.
  • Neurosurgical or Musculoskeletal surgery in last 12 months.
  • Neurological or Musculoskeletal injury within the past month.
  • Pain that interferes with the ability to assume side-lying position.
  • Medication for hypertonicity: Participants may be on medicine for abnormal tone.
  • However, there must not be any of the following:
  • Change in dosage or type of medication during the past 6 months
  • Botox injection(s) within 6 months.

结局指标

主要结局

Selective Control Assessment of Lower Extremity (SCALE)

时间窗: Baseline to 4 weeks

Each item is rated 2-0, 2 being Normal and 0 being Unable to Move

次要结局

  • Fugl-Meyer Assessment-Lower Extremity component (FMA-LE)(Baseline to 4 weeks)
  • 10-meter walk test(Baseline to 4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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