StrokeAphasiaGameNCT02458222
Efficacy of Language Games as Therapy for Post Stroke Aphasia
A study testing language game therapy and standard therapy in people with Stroke and Aphasia, run by University of Birmingham at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- language game therapy and standard therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2015to Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Moor Green Out-Patient Brain Injury Service
Birmingham, West Midlands, B13 8JL
Louise Lander, MSc, 44 121 466 6070, Louise.Lander@BHAMCLouise.Lander@BHAMCommunity.nhs.uk
Andrew Olson, PhD
About this study
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.
Read the 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.
- Being tested
- language game therapy, standard therapy
- Medical subject headings
- Stroke, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
language game therapyOther
participants will take part in game therapy
standard therapyOther
usual clinical care
| Study group | Role | What they receive |
|---|---|---|
| game therapy then standard therapy | Experimental | participants will take part in language game therapy followed by standard aphasia therapy Receives: Other: language game therapy; Other: standard therapy |
| standard therapy then game therapy | Experimental | participants will have standard aphasia therapy first then will take part in language game therapy Receives: Other: language game therapy; Other: standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
Measures of improvement in connected speech using method from Comprehensive Aphasia Test. Comparison of improvement following each type of language game.
Measured: Assessment carried out immediately after game 1 and game 2, at 4 weeks and 7 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sean Jennings, PhD, Study chair, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458222
- Sponsor's protocol ID
- RG_14-300
- Acronym
- AphasiaGame
- Status last verified
- Mar 2021
- First submitted
- 1 May 2015
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Language Games as Therapy for Post Stroke Aphasia
- ClinicalTrials.gov ID
- NCT02458222
- Acronym / sponsor ID
- AphasiaGame / RG_14-300
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 1 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| game therapy then standard therapy | Experimental | Other: language game therapy, Other: standard therapyparticipants will take part in language game therapy followed by standard aphasia therapy |
| standard therapy then game therapy | Experimental | Other: language game therapy, Other: standard therapyparticipants will have standard aphasia therapy first then will take part in language game therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| language game therapyparticipants will take part in game therapy | Other | game therapy then standard therapy, standard therapy then game therapy |
| standard therapyusual clinical care | Other | game therapy then standard therapy, standard therapy then game therapy |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Jennings, PhD study chair
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing language game therapy and standard therapy in people with Stroke and Aphasia, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Olson, PhD (+44 121 414 3328, olsonac@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.