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Active Cue-Training in Neglect

Primary Purpose

Hemispatial Neglect

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cueing
Sponsored by
Klinikum Bremen Ost
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemispatial Neglect focused on measuring Hemispatial Neglect, cueing, egocentric-allocentric, early rehabilitation, parietal tDCS

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous known dementia
  • Normal pressure hydrocephalus

Exclusion Criteria for tDCS Add-on (not exclusion of the intervention):

  • Shunt
  • Craniectomy
  • Epilepsy
  • Other metal implants

Sites / Locations

  • Klinikum Bremen-Ost

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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

- unspecific neglect treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in standardized evaluation of the body posture
A blinded neurologist evaluates spontaneous and cued body posture (head, eyes, trunk) for ipsilesional, moderate ipsilesional or no deviation.
Change in Apples Cancellation Task
a standardized measurement for the evaluation of egocentric and allocentric neglect symptoms
Change in activities of daily living using the Catherine Bergego Scale
The blinded hospital staff evaluates activities of daily living by using the Catherine Bergego scale with specified scoring criteria

Full Information

First Posted
October 19, 2016
Last Updated
March 5, 2018
Sponsor
Klinikum Bremen Ost
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1. Study Identification

Unique Protocol Identification Number
NCT02945592
Brief Title
Active Cue-Training in Neglect
Official Title
Active Cue-Training in Neglect
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Klinikum Bremen Ost

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemispatial Neglect
Keywords
Hemispatial Neglect, cueing, egocentric-allocentric, early rehabilitation, parietal tDCS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
adaptive, therapeutic cueing during reading tasks adaptive, therapeutic cueing during visuo spatial tasks
Arm Title
Control
Arm Type
No Intervention
Arm Description
- unspecific neglect treatment
Intervention Type
Behavioral
Intervention Name(s)
Cueing
Primary Outcome Measure Information:
Title
Change in word and word-part omissions in standardized reading of text and word list
Description
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.
Time Frame
Primary Outcome Measure is assessed two times in the first week (3 days in between), after week 4, after week 7, after week 8
Secondary Outcome Measure Information:
Title
Change in standardized evaluation of the body posture
Description
A blinded neurologist evaluates spontaneous and cued body posture (head, eyes, trunk) for ipsilesional, moderate ipsilesional or no deviation.
Time Frame
Secondary Outcome Measure is assessed two times in the first week (3 days in between), after week 4, after week 7, after week 8
Title
Change in Apples Cancellation Task
Description
a standardized measurement for the evaluation of egocentric and allocentric neglect symptoms
Time Frame
Secondary Outcome Measure is assessed two times in the first week (3 days in between), after week 4, after week 7, after week 8
Title
Change in activities of daily living using the Catherine Bergego Scale
Description
The blinded hospital staff evaluates activities of daily living by using the Catherine Bergego scale with specified scoring criteria
Time Frame
Secondary Outcome Measure is assessed after week 1, after week 4, after week 7, after week 8

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Left sided neglect Capacity of at least 30 minutes Ability to read in German language Mobilization of 80% Exclusion Criteria: Previous known dementia Normal pressure hydrocephalus Exclusion Criteria for tDCS Add-on (not exclusion of the intervention): Shunt Craniectomy Epilepsy Other metal implants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helmut Hildebrandt, Prof. Dr.
Organizational Affiliation
Universität Oldenburg, Klinikum Bremen-Ost
Official's Role
Study Director
Facility Information:
Facility Name
Klinikum Bremen-Ost
City
Bremen
ZIP/Postal Code
28325
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Active Cue-Training in Neglect

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