App-based rehab plus personalized nutrition to help swallowing recover after stroke.
Effectiveness of an mHealth Intervention, Based on Rehabilitation and a Personalised Nutrition Plan, in the Recovery and Improvement of Dysphagia in Patients Diagnosed With Stroke
This will see if a smartphone or tablet app that provides rehab exercises and a personalized nutrition plan, added to usual care, helps adults with post-stroke swallowing problems recover better than usual care alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Cadiz Academic / other |
| Locations | 1 site (Algeciras, Cadiz) |
| Trial ID | NCT07267468 on ClinicalTrials.gov |
What this trial studies
Adults with post-stroke oropharyngeal dysphagia are assigned to receive usual clinical care with or without an mHealth intervention delivered via a smartphone/tablet app. The app supplies rehabilitation exercises, educational content, follow-up, and a tailored nutrition plan to support home-based recovery. Key outcomes include measures of swallowing recovery, rates of complications such as aspiration pneumonia and malnutrition, adherence, and quality of life during follow-up. The trial is conducted at the University of Cadiz and Punta Europa University Hospital in Algeciras, Spain, with exclusions for severe cognitive impairment, major visual or language barriers, and patients in terminal/palliative or end-of-life care.
Who should consider this trial
Good fit: Adults (18+) with any degree of swallowing impairment after a stroke who can use a smartphone or tablet and do not have severe cognitive, visual, or language barriers are ideal candidates.
Not a fit: Patients in terminal/palliative care, with severe cognitive impairment, major visual impairment, or who cannot use the app or adhere to the prescribed program are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could speed swallowing recovery, reduce aspiration-related complications like pneumonia and malnutrition, and improve patients' quality of life.
How similar studies have performed: Previous tele-rehabilitation and mHealth pilot studies for post-stroke rehabilitation and dysphagia support have shown promising preliminary results, but large definitive trials of mHealth combined with personalized nutrition are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects aged 18 years or older. * Patients with any degree of impairment in swallowing/oropharyngeal dysphagia to liquids following a stroke (ACV). Exclusion Criteria: * Hospitalized patients presenting any type of visual barrier. * Patients in terminal palliative care. * Patients in the final days of life phase. * Patients with severe cognitive impairment. * Patients with a language barrier regarding the use of the App. Subject Withdrawal Criteria: * Revocation of consent. In this case, the subject will exit the study and will not be replaced by another subject, being considered a "loss". * Lack of adherence to the prescribed training plan exceeding 20% of the scheduled sessions.
Where this trial is running
Algeciras, Cadiz
- Faculty of Nursing. Punta Europa University Hospital — Algeciras, Cadiz, Spain (Recruiting)
Study contacts
- Principal investigator: Eduardo Sánchez-Sánchez, Ph.D. — University of Cadiz. Andalusian Healthcare Service
- Study coordinator: Eduardo Sánchez-Sánchez, Ph.D.
- Email: eduardo.sanchez@uca.es
- Phone: +34 956028110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.