NCT02458222

Brief Summary

Aphasia is a language impairment experienced by about one third of stroke patients. This often devastating condition is treated by speech and language therapists (SLTs). There is evidence that language games delivered at the right intensity are an efficacious means of improving communication for people with post stroke aphasia. However, it is unclear which mechanism of language facilitation used in a game works best. This study will provide evidence for the "active ingredient" of a game, together with measures of efficacy, feasibility and enjoyment compared to standard aphasia therapy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 1, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

9.7 years

First QC Date

May 1, 2015

Last Update Submit

March 2, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Comprehensive Aphasia Test (Swinburn et al 2004)

    Measures of language performance taken as designated in the various sub-tests, and comparisons of improvement in those measures after game therapy and after standard therapy. These will measure the general efficacy of the intervention.

    Assessment carried out prior to commencement of language game therapy, and immediately after language game therapy, 10 week interval. Assessment also carried out prior to and immediately after standard therapy, approx 12 week interval.

  • Communication Outcomes After Stroke Scale (Long et al, 2008)

    Measures of participants' subjective views of communicative abilities taken as designated by the test, and comparisons of improvement in those measures after game therapy and after standard therapy. These will measure the impact of therapy on general functional communication.

    Assessment carried out prior to commencement of language game therapy, and immediately after language game therapy, 10 week interval. Assessment also carried out prior to and immediately after standard therapy, approx 12 week interval.

  • Picture naming of words targeted in game therapy

    Confrontational picture naming of 180 words targeted in game therapy- points awarded for correct naming, and comparisons of improvement in those measures after game therapy and after standard therapy. These will measure therapy effects for the items that are specifically treated based on single word production.

    Assessment carried out prior to commencement of language game therapy, and immediately after language game therapy, 10 week interval. Assessment also carried out prior to and immediately after standard therapy, approx 12 week interval.

  • Picture description of words targeted in game therapy

    Measures of improvement in connected speech using method from Comprehensive Aphasia Test. Comparison of improvement following game therapy and following standard therapy. These will measure the ability of participants to use targeted words, but in a functional communication context -- i.e. producing phrases and sentences to describe a scene.

    Assessment carried out prior to commencement of language game therapy, and immediately after language game therapy, 10 week interval. Assessment also carried out prior to and immediately after standard therapy, approx 12 week interval.

Secondary Outcomes (2)

  • Picture naming of words targeted in game therapy to ascertain effects of different facilitatory techniques - multiple baseline measure

    Assessment carried out immediately after game 1 and game 2, at 4 weeks and 7 weeks.

  • Picture description of words targeted in game therapy to ascertain effects of different facilitatory techniques - multiple baseline measure

    Assessment carried out immediately after game 1 and game 2, at 4 weeks and 7 weeks.

Study Arms (2)

game therapy then standard therapy

EXPERIMENTAL

participants will take part in language game therapy followed by standard aphasia therapy

Other: language game therapyOther: standard therapy

standard therapy then game therapy

EXPERIMENTAL

participants will have standard aphasia therapy first then will take part in language game therapy

Other: language game therapyOther: standard therapy

Interventions

participants will take part in game therapy

game therapy then standard therapystandard therapy then game therapy

usual clinical care

game therapy then standard therapystandard therapy then game therapy

Eligibility Criteria

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

You may qualify if:

  • Adults who have suffered a stroke a minimum of 2 months prior to commencement of the intervention. They will present with expressive aphasia, with relatively preserved language comprehension. They will have been fully fluent in English before the stroke.

You may not qualify if:

  • Severe perceptual or cognitive deficits. History of other neurological, psychiatric or neurodegenerative disease impairing language or communicative ability. Severe visual agnosia. Severe limb apraxia. Severe dysarthria. Drug or alcohol abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moor Green Out-Patient Brain Injury Service

Birmingham, West Midlands, B13 8JL, United Kingdom

RECRUITING

MeSH Terms

Conditions

StrokeAphasia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Sean Jennings, PhD

    University of Birmingham

    STUDY CHAIR

Central Study Contacts

Andrew Olson, PhD

CONTACT

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

May 1, 2015

First Posted

June 1, 2015

Study Start

August 1, 2015

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

March 3, 2021

Record last verified: 2021-03

Locations