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An Evaluation of a New Nonverbal Treatment for Global Aphasia

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cognitive therapy
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

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

Inclusion Criteria:

  • have global aphasia as diagnosed by an SLT
  • have little or no verbal output
  • inconsistent single word comprehension
  • little or no ability to read or write
  • little or no ability to use alternative modes of communication
  • Little or no ability to make choices in function
  • no diagnosis/history of a progressive neurological condition
  • no diagnosis of hearing loss
  • no diagnosis/history of a mental health condition
  • English as a first language

Exclusion Criteria:

  • has another form of aphasia
  • is able to consistently express basic needs non-verbally or verbally.
  • is able to participate in communicative interaction with a familiar other
  • has a history of a progressive neurological condition
  • has hearing loss
  • has a diagnosis/history of a mental health condition
  • does not have English as a first language.

Sites / Locations

  • University College London, Research Dept of Language and Cognition

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

No Intervention

Arm Label

BASELINE TESTING

Treatment

Post intervention

Arm Description

Language and cognitive assessments conducted

Intervention given: visual tracking pressing a button every time a picture is seen on the screen playing dominoes and snap pressing a button every time a specific picture is seen on the screen Pressing a button every time a specific sound is heard Matching objects to a picture Matching gestures to objects Matching two connected objects Sorting objects by categories Matching sounds to objects "Complete the category" and "odd on out with objects" Choosing target objects by pointing Choosing objects to complete the category by pointing

Repeated testing

Outcomes

Primary Outcome Measures

American Speech and Hearing Association -Functional Assessment of Communication
Questionnaire completed by friend/relative
Constructed Interaction Task
video recorded interaction

Secondary Outcome Measures

Aphasia Screening Test
Language assessment
Mood Screen
depression screening tool
Pyramids and Palm Trees Test
pictorial semantic assessment
Wisconsin Card Sorting Test
cognitive assessment
Butt Non verbal reasoning test
cognitive assessment
Western Aphasia Battery cognitive sub test
cognitive assessment

Full Information

First Posted
June 22, 2015
Last Updated
January 27, 2020
Sponsor
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT02545894
Brief Title
An Evaluation of a New Nonverbal Treatment for Global Aphasia
Official Title
An Investigation Into the Effect of a Novel, Non Verbal, Cognitive Treatment on Functional Communication in Global Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London

4. Oversight

5. Study Description

Brief Summary
People with global aphasia (PwGA) post stroke have little to no meaningful communication abilities (ie limited comprehension, spoken language, reading and writing abilities).A proportion of PwGA will also have limited abilities to use any alternative means of communication e.g. gesture, pictures or computer devices. There is a suggestion in the literature that this is because of co-occurring cognitive deficits. The consequence is that these clients are unable to reliably communicate even their basic needs.This is commonly known as having no functional communication abilities. Such PwGA tend not to respond to standard speech and language therapy interventions. This research will investigate the effect of a new cognitive intervention designed to improve basic functional communication abilities. The treatment will be nonverbal and involve computer and paperbased tasks ordered hierarchically from basic to more complex tasks. Six to eight participants will take part. All their sessions will take place in their own home. For some this may be a care home. They will first complete a diagnostic communication assessment in order for baseline abilities to be established. Further formal language and cognitive assessments will be conducted over a period of 6 weeks. A relative/friend will complete a questionnaires about mood/communication. The PwGA will also be videoed interacting with the research student e.g. looking at a magazine, completing a jigsaw, answering questions and making choices non-verbally. The participants then receive the new intervention 3 times a week for 6 consecutive weeks. All intervention sessions will be videoed. Then participants will be reassessed over 2 weeks using the same assessments as prior to the intervention. The questionnaire with their relative/friend and videoed activity session will also be repeated. After a twelve week break the participant will be videoed interacting with the research student complete some of the assessments again and their relative will re-complete the questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BASELINE TESTING
Arm Type
No Intervention
Arm Description
Language and cognitive assessments conducted
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Intervention given: visual tracking pressing a button every time a picture is seen on the screen playing dominoes and snap pressing a button every time a specific picture is seen on the screen Pressing a button every time a specific sound is heard Matching objects to a picture Matching gestures to objects Matching two connected objects Sorting objects by categories Matching sounds to objects "Complete the category" and "odd on out with objects" Choosing target objects by pointing Choosing objects to complete the category by pointing
Arm Title
Post intervention
Arm Type
No Intervention
Arm Description
Repeated testing
Intervention Type
Behavioral
Intervention Name(s)
Cognitive therapy
Intervention Description
The tasks are: visually tracking a picture as it moves across the computer screen pressing a button every time a picture is seen on the screen pressing a button every time a specific picture is seen on the screen Pressing a button every time a specific sound is heard Matching objects to a picture Matching gestures to objects Matching two connected objects Sorting objects by categories Matching sounds to objects "Complete the category" and "odd on out with objects" Choosing target objects by pointing Choosing objects to complete the category by pointing
Primary Outcome Measure Information:
Title
American Speech and Hearing Association -Functional Assessment of Communication
Description
Questionnaire completed by friend/relative
Time Frame
27 weeks
Title
Constructed Interaction Task
Description
video recorded interaction
Time Frame
27 weeks
Secondary Outcome Measure Information:
Title
Aphasia Screening Test
Description
Language assessment
Time Frame
14 weeks
Title
Mood Screen
Description
depression screening tool
Time Frame
27 weeks
Title
Pyramids and Palm Trees Test
Description
pictorial semantic assessment
Time Frame
27 weeks
Title
Wisconsin Card Sorting Test
Description
cognitive assessment
Time Frame
14 weeks
Title
Butt Non verbal reasoning test
Description
cognitive assessment
Time Frame
27 weeks
Title
Western Aphasia Battery cognitive sub test
Description
cognitive assessment
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: have global aphasia as diagnosed by an SLT have little or no verbal output inconsistent single word comprehension little or no ability to read or write little or no ability to use alternative modes of communication Little or no ability to make choices in function no diagnosis/history of a progressive neurological condition no diagnosis of hearing loss no diagnosis/history of a mental health condition English as a first language Exclusion Criteria: has another form of aphasia is able to consistently express basic needs non-verbally or verbally. is able to participate in communicative interaction with a familiar other has a history of a progressive neurological condition has hearing loss has a diagnosis/history of a mental health condition does not have English as a first language.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Beeke, PhD
Organizational Affiliation
UCL
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College London, Research Dept of Language and Cognition
City
London
ZIP/Postal Code
WC1N
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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An Evaluation of a New Nonverbal Treatment for Global Aphasia

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