跳至主要内容
临床试验/NCT02945592
NCT02945592已完成不适用

Active Cue-Training in Neglect

Klinikum Bremen Ost2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2016年10月最近更新:
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
26
试验地点
2
主要终点
Change in word and word-part omissions in standardized reading of text and word list

研究概览

简要总结

The presented study investigates standardized visual cueing in reading and visual spatial task as a treatment method for spatial neglect. In a randomized controlled design patients receive either cued reading and visual spatial tasks (intervention) or treatment which is unspecific to neglect (control).

In the intervention condition, patients with left-sided neglect receive intense training, including reading and visual spatial task with standardized and adapted visual cueing by the therapist. Improvements in reading and visual spatial tasks lead to a reduction of cues by the therapist. Accordingly, the patient has to apply self-cueing over time in order to solve the task.

For the control condition, all patients receive unspecific treatment without any standardized adapted cueing implemented by the therapist.

To enhance the effectivity of cueing in reading and visual spatial tasks, the investigators additionally conduct parietal transcranial direct current stimulation (tDCS) in those patients without tDCS exclusion criteria (see exclusion criteria below).

It is hypothesised that systematic and adaptive therapeutic cueing leads to a significant reduction of omissions of word and word parts in reading.

UPDATE: No Add-on tDCS was performed since it was not applicable for our severly impaired patients due to the strict exclusion criteria of tDCS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Left sided neglect
  • Capacity of at least 30 minutes
  • Ability to read in German language
  • Mobilization of 80%

排除标准

  • Previous known dementia
  • Normal pressure hydrocephalus
  • Exclusion Criteria for tDCS Add-on (not exclusion of the intervention):
  • Craniectomy
  • Other metal implants

研究组 & 干预措施

Intervention

Experimental
  • adaptive, therapeutic cueing during reading tasks
  • adaptive, therapeutic cueing during visuo spatial tasks

干预措施: Cueing (Behavioral)

Control

No Intervention
  • unspecific neglect treatment

结局指标

主要结局

Change in word and word-part omissions in standardized reading of text and word list

时间窗: Primary Outcome Measure is assessed two times in the first week (3 days in between), after week 4, after week 7, after week 8

the patient has to read a standardized text of 55 words and a word list of 13 words. Omissions of the complete word and/or of a word part are counted.

次要结局

  • Change in activities of daily living using the Catherine Bergego Scale(Secondary Outcome Measure is assessed after week 1, after week 4, after week 7, after week 8)
  • Change in standardized evaluation of the body posture(Secondary Outcome Measure is assessed two times in the first week (3 days in between), after week 4, after week 7, after week 8)
  • Change in Apples Cancellation Task(Secondary Outcome Measure is assessed two times in the first week (3 days in between), after week 4, after week 7, after week 8)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nergiz Turgut

MSc

Klinikum Bremen Ost

研究点 (2)

Loading locations...

相似试验