Efficacy of Language Games as Therapy for Post Stroke Aphasia (AphasiaGame)

March 2, 2021 updated by: University of Birmingham
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Participants with moderate-severe difficulties will play picture naming games, involving self-cuing using gesture and circumlocution. Those with mild difficulties will play story-telling games, using similar self-cuing techniques. Change in language performance will be measured and compared to that achieved by the same participants following an episode of standard aphasia therapy from their local SLT (i.e. normal care).

This study will build on a growing evidence base for the efficacy of therapeutic language games in post stroke aphasia. In today's resource-constrained National Health Service, SLTs are continually searching for cost-effective, innovative ways of delivering therapy. Language games based on sound neuro-scientific principles have the potential to deliver improvements in functional communication by means of an enjoyable and motivating activity, and moreover can be done cost effectively. Improvements have been demonstrated from the acute through to the chronic stage of stroke. A number of factors are said to contribute to the outcomes achieved: intensity of training, behavioural relevance and focussed use of capacities. This study intends to explore in more depth some of the specific behaviours that can occur spontaneously or than can be prompted to facilitate language. The aim is to uncover the "active ingredient", and thereby ensure that participants can benefit maximally from therapeutic language games.

This study will contribute to the search for cost effective treatment for post-stroke aphasia, which offers ease and flexibility of delivery, is enjoyable and motivating for patients, and works.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B13 8JL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: game therapy then standard therapy
participants will take part in language game therapy followed by standard aphasia therapy
Other: language game therapy
participants will take part in game therapy
Other: standard therapy
usual clinical care
Experimental: standard therapy then game therapy
participants will have standard aphasia therapy first then will take part in language game therapy
Other: language game therapy
participants will take part in game therapy
Other: standard therapy
usual clinical care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Comprehensive Aphasia Test (Swinburn et al 2004)
Time Frame: 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.
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)
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Picture naming of words targeted in game therapy to ascertain effects of different facilitatory techniques - multiple baseline measure
Time Frame: Assessment carried out immediately after game 1 and game 2, at 4 weeks and 7 weeks.
Confrontational picture naming of 180 words targeted in game therapy- points awarded for correct naming, and comparisons of improvement in those measures after each type of language game.
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
Time Frame: Assessment carried out immediately after game 1 and game 2, at 4 weeks and 7 weeks.
Measures of improvement in connected speech using method from Comprehensive Aphasia Test. Comparison of improvement following each type of language game.
Assessment carried out immediately after game 1 and game 2, at 4 weeks and 7 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Birmingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Sean Jennings, PhD, University of Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RG_14-300

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on language game therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings