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Randomised Controlled Trial of an Intensive Comprehensive Aphasia Programme for People With Post-Stroke Aphasia
Sponsor: University College, London
Summary
Research question Does participation in an Intensive Comprehensive Aphasia Programme produce a meaningful change in the communication of people with aphasia, their quality of life and that of their carers? Background Aphasia is a persistent language disorder that severely impairs communicative abilities. Most commonly induced by a stroke, aphasia reduces quality of life more than any other condition. People with aphasia (PWA) and their carers feel abandoned by the NHS due to the limited treatment options available. Meanwhile, neuroscientific evidence suggests that PWA can make meaningful gains in communicative ability, mood, and quality of life if therapists are given enough time to work with them. Although studies indicate Intensive Comprehensive Aphasia Programmes (ICAPs) are effective ways to deliver such therapy, no randomised controlled trial (RCT) of an ICAP has yet been conducted. We propose conducting the first ever ICAP RCT. Aims and objectives Clinical: i) To test the efficacy of an ICAP in improving PWAs' language impairment, communicative ability, mood, and quality of life; ii) to measure the quantity and quality of therapy received in the community by the standard care group; iii) to assess the significance of age and time-since-stroke in PWA's responses to ICAP intervention. Mechanistic: To test whether combining baseline behaviour and MRI brain scans can usefully predict individual patients' responses to the ICAP treatment. Methods Our RCT will test the effect of an ICAP intervention by randomly assigning PWA and their carers to one of two groups receiving either ICAP or standard care at two participating sites. We aim to deliver 100 hours of ICAP therapy over a 4-week schedule to adult PWA who are more than 3 months post-stroke. We will compare the effects of the ICAP, comprising complex interventions with multiple interacting therapeutic components, with standard care, the quantity and quality of which will be recorded by research assistants. The primary outcome measure is a standardized scale for measuring quality of life for PWA (SAQOL-39g). The primary endpoint is 4 months post-randomisation. We will also test for effects at 9 months. Anticipated impacts Our trial could provide the evidence needed to transform how the NHS treats PWA and their carers. If we demonstrate that participating in an ICAP leads to clinically meaningful and sustained improvements, the next stage in achieving wider NHS roll-out will be a multi-centre trial to investigate the cost- and clinical effectiveness of ICAPs across the UK.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
334
Start Date
2026-09-01
Completion Date
2030-08-31
Last Updated
2026-02-04
Healthy Volunteers
Yes
Conditions
Interventions
ICAP
As defined by the new framework commissioned by the NIHR and the MRC \[44\], ICAPs are complex interventions with multiple interacting components. We have published our ICAP operating manual using the TIDieR format (Template for Intervention Description and Replication) to ensure it complies with intentionally accepted requirements (see uploads) \[45, 46\] Accordingly, no individual PWA or their carer will receive all possible therapeutic components; instead the therapists will personalise content according to individual needs to help them achieve their goals. A further key feature of the ICAP is that the treating therapists (4 Speech and Language Therapists and one Clinical Psychologist) work as a team, meaning all of them will work with each PWA over the 4-week ICAP.
Standard Care (in control arm)
Although the amount of therapy received by PWA in the community varies, the most in-depth study of this variation across 21 UK-based SLT departments concludes as follows: "Where resources are in short supply, therapists have the difficult ethical decision of providing therapeutic levels of intervention to some patients, or providing sub therapeutic levels to all. Currently it looks as if the latter is most common in practice."\[48\] This study found the majority of PWA over a year post-stroke were not receiving any therapy, while a minority were receiving \~6.3 hours, ranging widely from 0.5-41.5 hours. To capture the quantity and quality of the therapy received by PWA in this arm (and the ICAP group once they complete the ICAP) we will ensure the research team complete the relevant sections of the Client Service Receipt Inventory at each time point.
Locations (1)
UCL Queen Square Institute of Neurology
London, United Kingdom