N/A
Completed N=83
Exercise for Swallowing Problems After Stroke
Cerebrovascular Accident · Deglutition Disorders
Source: ClinicalTrials.gov NCT00722111 ↗
Enrolled (actual)
83
Serious AEs
—
Results posted
Mar 2018
Primary outcomePrimary: Isometric Lingual Pressure — 49 kPa
Summary
The purpose of this study is to determine whether stroke patients with swallowing problems will show greater swallowing improvement with intense oral exercise than subjects who perform either a low intensity oral exercise or a sham exercise.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Isometric Lingual Pressure |
49 | — |
| PRIMARY Maximum Isometric Tongue Pressure |
49; 78 | — |
Eligibility Criteria
Inclusion Criteria
- 3 months post ischemic or hemorrhagic stroke
- 45 years of age or older
- physician approval of medical stability
- aspiration or penetration of the laryngeal vestibule (score of 3 or higher on Penetration/Aspiration Scale) or post swallow residue in the oropharynx
- able to manage own secretions with no signs of aspiration
- the capacity to provide informed consent
Exclusion Criteria
- neurologic insult (other than stroke) or neuromuscular disease
- history of radiation to the head or neck
- poorly controlled psychosis
- lack the capacity to complete the exercise program
- refractory alcoholism (on AWD precautions)
- class IV congestive heart failure
- sever chronic obstructive pulmonary disease (home oxygen dependent)
- end-stage renal failure
- allergy to barium (used in radiographic swallowing assessment
Subjects with known contraindication will be excluded from the MRI portion of the protocol:
- Cardiac pacemakers
- Aneurysm clips
- Neurostimulators
- Cochlear implant
- Ossicular prostheses
- Intracranial or intraorbital foreign bodies
- Claustrophobia
Data sourced from ClinicalTrials.gov (NCT00722111). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.