RCT of an ICAP

• Research type

  Research Study

• Full title

  Randomised Controlled Trial of an Intensive Comprehensive Aphasia Programme for People with Post-Stroke Aphasia

• IRAS ID

  335270

• Contact name

  Alexander Leff

• Contact email

  a.leff@ucl.ac.uk

• Sponsor organisation

  University College London

• Clinicaltrials.gov Identifier

  NCT07386652

• Clinicaltrials.gov Identifier

  UCL Data Protection number, Z6364106/2025/07/206

• Duration of Study in the UK

  4 years, 11 months, 31 days

• Research summary

  Aims
  Clinical: To test the efficacy of an Intensive Comprehensive Aphasia Programme (ICAP) in improving PWAs’ language impairment, communicative ability, mood, and quality of life

  Mechanistic: To test whether combining baseline behaviour and MRI brain scans can usefully predict individual patients’ responses to the ICAP treatment.

  Design: We will test the effect of an ICAP intervention by randomly assigning people with aphasia (PWA) and their carers to one of two groups receiving either, 1) ICAP or 2) 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 at least 3 months post stroke. No upper limit for time since 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.

• REC name

  London - Queen Square Research Ethics Committee

• REC reference

  26/LO/0168

• Date of REC Opinion

  1 Apr 2026

• REC opinion

  Further Information Favourable Opinion