NCT02545894

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 10, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

1.5 years

First QC Date

June 22, 2015

Last Update Submit

January 27, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • American Speech and Hearing Association -Functional Assessment of Communication

    Questionnaire completed by friend/relative

    27 weeks

  • Constructed Interaction Task

    video recorded interaction

    27 weeks

Secondary Outcomes (6)

  • Aphasia Screening Test

    14 weeks

  • Mood Screen

    27 weeks

  • Pyramids and Palm Trees Test

    27 weeks

  • Wisconsin Card Sorting Test

    14 weeks

  • Butt Non verbal reasoning test

    27 weeks

  • +1 more secondary outcomes

Study Arms (3)

BASELINE TESTING

NO INTERVENTION

Language and cognitive assessments conducted

Treatment

EXPERIMENTAL

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

Behavioral: Cognitive therapy

Post intervention

NO INTERVENTION

Repeated testing

Interventions

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

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London, Research Dept of Language and Cognition

London, WC1N, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Suzanne Beeke, PhD

    UCL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2015

First Posted

September 10, 2015

Study Start

December 1, 2014

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

January 29, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations