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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02458222
Other study ID # RG_14-300
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 2015
Est. completion date April 2025

Study information

Verified date March 2021
Source University of Birmingham
Contact Andrew Olson, PhD
Phone +44 121 414 3328
Email olsonac@bham.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date April 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
language game therapy
participants will take part in game therapy
standard therapy
usual clinical care

Locations

Country Name City State
United Kingdom Moor Green Out-Patient Brain Injury Service Birmingham West Midlands

Sponsors (1)

Lead Sponsor Collaborator
University of Birmingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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.
Primary 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 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. Assessment carried out immediately after game 1 and game 2, at 4 weeks and 7 weeks.
Secondary 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. Assessment carried out immediately after game 1 and game 2, at 4 weeks and 7 weeks.
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