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Electrical muscle stimulation programme for swallowing post stroke

Efficacy of the AMPCARE ESP protocol in improving swallowing in patients with persistent dysphagia post stroke

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN80084036
Enrollment
30
Registered
2013-07-24
Start date
2013-06-18
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Stroke Research Network

Interventions

AMPCARE ESP, AMPCARE Effective Swallowing Programme (a combination of electrical stimulation plus specific laryngeal elevation exercises) A cohort of 30 patients with persistent (>1 mo

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Swallowing difficulty which is due to stroke (symptoms should include reduced laryngeal elevation, as determined by videofluoroscopy) 2. These difficulties should have persisted for = 1 month (in order to control for spontaneous recovery and response to usual care) 3. Medical stability 4. Absence of any other neurological disease 5. Availability to participate in a treatment session each weekday (either at home or in clinic) for a 4-week period

Exclusion criteria

Exclusion criteria: 1. Under 18 years of age 2. Have an implanted electronic device e.g. pacemaker 3. Have moderate/severe cognitive or communication difficulties (as they may be unable to give informed consent, or struggle to understand and comply with treatment instructions) 4. Present with progressive disease 5. Are pregnant 6. Have active cancerous lesions or infections in the treatment site

Design outcomes

Primary

MeasureTime frame
1. Swallowing function, measured by: 1.1. MASA - Mann Assessment of Swallowing Ability (validated tool to give a numerical score of patients? swallowing ability) 1.2. FOIS - Functional Oral Intake Scale (well used and psychometrically validated tool to measure change in functional eating abilities of Stroke patients over time) 1.3. Rosenbek PAS - Penetration-Aspiration Scale (validated tool for use during videofluoroscopy to evaluate the presence and severity of aspiration i.e. penetration of food and/or fluid into the airway below the level of the vocal folds) 1.4. SWAL-QOL - Patients' assessment of dysphagia related quality of life (validated tool to allow patients to rate 10 dysphagia related quality of life concepts) 2. Patients will also be asked to rate the tolerability of the treatment. Information on the safety of the treatment protocol will be evaluated by recording of any adverse effects during the study Timepoint(s): 4 weeks following start of treatment

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026