Exercise for Swallowing Problems After Stroke
Rehabilitation Exercise for Dysphagia Subsequent to Stroke
1 other identifier
interventional
83
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2008
CompletedFirst Posted
Study publicly available on registry
July 25, 2008
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
March 21, 2018
CompletedMarch 21, 2018
March 1, 2018
10 months
July 23, 2008
October 17, 2013
March 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Isometric Lingual Pressure
Tongue Strength
8 weeks
Maximum Isometric Tongue Pressure
Peak isometric pressure at 4 sensors
16 months
Study Arms (4)
Arm 1
EXPERIMENTALlingual press (high-intensity, oral, non-swallowing)
Arm 2
EXPERIMENTALeffortful swallowing (high-intensity swallowing)
Arm 3
EXPERIMENTALnatural swallowing (high frequency, low intensity swallowing)
Arm 4
SHAM COMPARATORnon-oral sham (control) exercise
Interventions
Eligibility Criteria
You may qualify if:
- months post ischemic or hemorrhagic stroke
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wlliam S. Middleton Memorial Veterans Hospital, Madison
Madison, Wisconsin, 53705, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. JoAnne Robbins
- Organization
- VAHSRD
Study Officials
- PRINCIPAL INVESTIGATOR
JoAnne Robbins, PhD
Wlliam S. Middleton Memorial Veterans Hospital, Madison
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2008
First Posted
July 25, 2008
Study Start
February 1, 2011
Primary Completion
December 1, 2011
Study Completion
June 1, 2012
Last Updated
March 21, 2018
Results First Posted
March 21, 2018
Record last verified: 2018-03