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临床试验/NCT02419222
NCT02419222已完成不适用

Feasibility of Using Prism Adaptation to Treat Spatial Neglect and Motor Function in Stroke Survivors With Multiple Lesions

Kessler Foundation4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年1月1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
发起方
入组人数
30
试验地点
4
主要终点
CBS via Kessler Foundation Neglect Assessment Process

研究概览

简要总结

This research project is a study designed to address both motor and cognitive changes after stroke. Treatment for SN is elusive however there is support for prism adaptation treatment (PAT). Therapists need to know more about the effects of this treatment and if it is feasible in a group of stroke survivors with multiple lesions because these are the patients they are treating in the clinical setting. Also, it has not been investigated that using PAT to remediate SN will then as a result increase spontaneous UE movement of the weak limb.

详细描述

This research project is a study designed to address both motor and cognitive changes after stroke, two common stroke disabilities. For example: two third of patients reported loss of upper limb function as a major problem after stroke and spatial neglect occurs in more than 350,000 US right hemisphere stroke survivors annually. These two impairments if not treated, lead to immediate impairment in basic life activities, long term functional disability, increased risk for falls and increased healthcare costs. The literature displays many strong research studies that trialed the use of multiple treatment approaches to remediate spatial neglect, including prism adaptation treatment (PAT), resulting in positive results. Similar findings result for treatment studies that attempt to remediate the upper extremity (UE). However, in all group of patients that were tested in these studies (both for spatial neglect and UE dysfunction) only had one stroke and past medical histories that were unremarkable. Rehabilitation professionals help clients that have had all types of strokes achieve improved quality of life by helping to increase independence by remediating impairment. In addition, these professionals need to know more about the effects of PAT in stroke survivors with multiple lesions because these are patients commonly being treated in the clinical setting. Also, it has not been investigated whether using PAT, a very promising and easy to administer treatment, to remediate spatial neglect will also increase spontaneous UE movement of the limb affected by the stroke because of an influence on motor-intentional aiming errors. Thus, in this pilot research proposal, the researcher intends to first investigate the feasibility of this two week treatment on stroke survivors that have had multiple lesions and second verify if PAT will improve spatial neglect and jointly increase spontaneous movement of the UE.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Between the ages of 18 and
  • New stroke on the right side of the brain.
  • Has an UE impairment of the arm affected by the stroke (WMFT score of less than 75).
  • Has the presence of spatial neglect (greater than 1 on the KF-NAP).
  • Is able to give informed consent.
  • Past medical history includes having had a stroke or more than one. This can be ischemic or hemorrhagic, and on either side of the brain.

排除标准

  • Is under the age of
  • Has severe communication deficit.
  • Has a left brain stroke as the primary diagnosis and/or the primary diagnosis is anything other than stroke.
  • Is blind in one or both eyes.
  • Is not staying at the inpatient rehabilitation hospital
  • Has a cognitive impairment that inhibits their ability to recall information.
  • Has severely impaired upper extremity function in bilateral arms (cannot participate in the prism task).

研究组 & 干预措施

Prism Adaptation

Experimental

Prism Adaptation Treatment is 20 minutes long, administered 10 consecutive days

干预措施: Prism Adaptation (Behavioral)

结局指标

主要结局

CBS via Kessler Foundation Neglect Assessment Process

时间窗: 30 minutes

The CBS is a 10-item scale for evaluating the severity of spatial neglect (Azouviet al., 1996). Thus, the CBS captures the heterogeneity of spatial neglect in the most functional way. The items include limb awareness, personal belongings, dressing, grooming, gaze orientation, auditory attention, navigation, collisions, eating, cleaning after a meal. Each item is scored from 0-3. Based on a CBS total score (range 0-30), a stroke survivor with unilateral brain damage can be categorized as no neglect (CBS=0), mild (CBS= 1-10), moderate (CBS= 11-20), or severe (CBS= 20-30). In 2012, Chen et al. addressed this obstacle by standardizing the method to use the CBS reliably in the clinic and trademarked the process to use in conjunction with the CBS as the Kessler Foundation Neglect Assessment Process (CBS via KF-NAP™).

次要结局

  • Functional Independence Measure(30 minutes)
  • Wolf Motor Function Test(45 min)
  • Behavior Inattention Test(15 minutes)
  • Motor Activity Log(15 minutes)

研究者

发起方
Kessler Foundation
申办方类型
Other
责任方
Sponsor

研究点 (4)

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