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临床试验/NCT03328468
NCT03328468已完成不适用

Development of Upper Limb Motor Scale "Awareness of Functional Tasks With Arm and Hand in Stroke"

University of Minnesota1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2017年12月30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
入组人数
41
试验地点
1
主要终点
Validity a new motor scale for upper extremity Upper Limb Motor Scale in people with stroke (AFAS scale

研究概览

简要总结

For the breathing intervention, participants completed two experimental sessions at least two weeks apart. The experimental sessions were randomized between the slow-breathing condition (6 breaths/min) or the control breathing condition (12 breaths/min). Breathing interventions were 15 minutes in length and completed with the assistance of the breathing app, Breathe Deep (Mineev, Bizi Apps LLC).

The breathing intervention is currently completed.

The reliability and validity study of AFAS is ongoing. This is a one-time visit for participants in which participants will undergo screening of sensation and movement as well as fill in some questionnaires.

详细描述

All participants had two visits for the breathing exercise. The only planned intervention was the breathing exercise, which is now concluded.

The protocol for the breathing intervention was as follows: The breathing protocol lasted 15 minutes. It was a guided breathing awareness session with a registered nurse (PhD student) who is also trained in integrative therapies and yoga instruction.

In parallel, during one of the visits the reliability and validity of a new scale for stroke to measure quality of movement and body awareness is tested.

This part is still ongoing and thus this becomes a one-time visit.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Females and males ages 18-99 years of age
  • •People with stroke who are medically stable with one or more ischemic or
  • •hemorrhagic stroke(s)
  • •left or right hemiplegia
  • •willing and able to attend a one-time behavioral testing session
  • •willing and able to sign consent to participate
  • •able to hear, read and comprehend instructions given during the study
  • •English speaking (or willing to work with a (student) translator)

排除标准

  • •cognitive impairment (Mini-mental State Exam-brief version, <13/16)
  • •contractures in the tested arm that would hinder testing arm movements
  • •adults lacking capacity to consent
  • •severe neglect, aphasia, apraxia
  • •other medical conditions that preclude participation

研究组 & 干预措施

Breathing Exercise

Experimental

干预措施: Breathing Exercise (Other)

结局指标

主要结局

Validity a new motor scale for upper extremity Upper Limb Motor Scale in people with stroke (AFAS scale

时间窗: Baseline

Scale using 0-45 for measurement, 0 being low and 45 being high.

Reliability of a new scale for stroke: Awareness of Functional Tasks with Arm and Hand in Stroke (AFAS scale)

时间窗: Baseline

AFAS contains 13 items

次要结局

  • Physical Body Experience Questionnaire (PBE)(Baseline)
  • Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES)(Baseline)
  • Revised Body Awareness Rating Scale (REVBA)(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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