Gamified naming therapy versus traditional speech-language pathology for post-stroke anomia in Arabic speakers

ISRCTN	ISRCTN25938988
DOI	https://doi.org/10.1186/ISRCTN25938988
Sponsor	Dhahran Health Center
Funder	Johns Hopkins Aramco Healthcare

Submission date: 07/04/2026
Registration date: 08/04/2026
Last edited: 08/04/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Yusuf Albustanji
Principal investigator, Scientific, Public

Johns Hopkins Aramco Healthcare
Dhahran
4321
Saudi Arabia

Phone	+966 0502702885
Email	yusufmohammed.albustanji@JHAH.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Parallel
Purpose	Diagnostic, Treatment
Scientific title	Gamified naming therapy versus traditional speech-language pathology for post-stroke anomia in Arabic speakers: a randomised pilot trial
Study objectives	Traditional speech-language pathology services face structural limitations: the global Speech-Language Pathologists (SLPs) shortage constrains access, particularly in the Middle East, and therapy is typically limited to one to two hours per week — far below the intensive dosage required for consolidation of lexical-retrieval improvements. Computerised naming treatment platforms can deliver high-dose practice with real-time feedback. Gamification — the application of game-design principles to non-game contexts — has demonstrated clinical utility in motor and cognitive rehabilitation. The iTalkBetter Phase II randomised trial demonstrated that AI-driven gamified digital therapy achieved significant improvements in chronic aphasia naming. Systematic reviews confirm high feasibility and safety of digital interventions for post-stroke language rehabilitation. No prior study has delivered gamified naming therapy within a fully Arabic-language platform, nor compared such a platform against a controlled comparator condition in a randomised design. This study has two primary objectives: (1) a detailed technical description of the Naming Gaming App platform; (2) a randomised pilot trial comparing gamified app-based therapy to an equated-contact-time traditional SLP comparator in Arabic-speaking adults with post-stroke anomia. As a pilot trial, the primary purpose is signal detection and feasibility evidence to power a definitive multisite RCT, not to provide conclusive efficacy evidence.
Ethics approval(s)	Approved 28/01/2026, Johns Hopkins Aramco Healthcare Institutional Review Board (IRB) (Johns Hopkins Aramco Healthcare, 2894 Floor 1 Dhahran Blvd, Dhahran, 34465, Saudi Arabia; +966 013 877 9000; yusufmohammed.albustanji@JHAH.com), ref: IRB # 24-04-039
Health condition(s) or problem(s) studied	Post stroke aphasia
Intervention	Arabic-speaking adults with confirmed post-stroke anomia (≥3 months post-onset) were randomly allocated (1:1, block randomisation, allocation concealment) to an Experimental Group (EG; n = 12) receiving 15 supervised gamified app sessions (45 min, 3×/week, five weeks), or a Control Group (CG; n = 12) receiving an equated-contact-time comparator condition of traditional SLP (2×/week, five weeks; total contact time equated at 675 minutes). Independent blinded assessors administered all outcome probes. Primary outcomes were trained item naming accuracy (/30) and untrained item generalisation (/30) at baseline and post-treatment. A post-hoc power analysis will be reported.
Intervention type	Behavioural
Primary outcome measure(s)	Trained item naming accuracy (/30) and untrained item generalisation accuracy (/30) measured using the Reliable Change Index (RCI) by a blinded independent assessor at baseline, five weeks of treatment and post treatment
Key secondary outcome measure(s)	A-CAT Aphasia Quotient (/100) and naming subtest (/20); naming latency; object vs. action naming (/15 each); error-type classification; four-week maintenance probes measured using the Reliable Change Index (RCI) by a blinded independent assessor at baseline, five weeks of treatment and post treatment
Completion date	14/03/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	24 Years
Upper age limit	78 Years
Sex	All
Target sample size at registration	24
Total final enrolment	24
Key inclusion criteria	1. Acquired aphasia following a single left-hemisphere stroke, confirmed by neuroimaging 2. Arabic as primary spoken language 3. Anomia confirmed by A-CAT naming subtest 4. ≥3 months post-stroke onset (revised from the initially planned ≥4 weeks threshold to minimise the contribution of acute spontaneous recovery) 5. Adequate vision and hearing to engage with app interface or clinic-based materials 6. Capacity to provide written informed consent
Key exclusion criteria	1. Participants with progressive neurological conditions 2. Significant cognitive impairment 3. Prior app-based therapy within the preceding six months
Date of first enrolment	07/01/2026
Date of final enrolment	14/03/2026

Locations

Countries of recruitment

Saudi Arabia

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

08/04/2026: Study’s existence confirmed by the Johns Hopkins Aramco Healthcare Institutional Review Board (JHAH IRB), Saudi Arabia.