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NCT Number: NCT02545894

An Evaluation of a New Nonverbal Treatment for Global Aphasia

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College London, Research Dept of Language and Cognition

London, WC1N, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cognitive therapy

Behavioral

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 outcomes

  1. American Speech and Hearing Association -Functional Assessment of Communication

    Time frame: 27 weeks

    Questionnaire completed by friend/relative

  2. Constructed Interaction Task

    Time frame: 27 weeks

    video recorded interaction

Secondary outcomes

  1. Aphasia Screening Test

    Time frame: 14 weeks

    Language assessment

  2. Mood Screen

    Time frame: 27 weeks

    depression screening tool

  3. Pyramids and Palm Trees Test

    Time frame: 27 weeks

    pictorial semantic assessment

  4. Wisconsin Card Sorting Test

    Time frame: 14 weeks

    cognitive assessment

  5. Butt Non verbal reasoning test

    Time frame: 27 weeks

    cognitive assessment

  6. Western Aphasia Battery cognitive sub test

    Time frame: 14 weeks

    cognitive assessment

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study title

An Investigation Into the Effect of a Novel, Non Verbal, Cognitive Treatment on Functional Communication in Global Aphasia

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 10, 2015
Registry last updated
Jan 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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