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Exercise for Swallowing Problems After Stroke

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ClinicalTrials.gov Identifier: NCT00722111
Recruitment Status : Completed
First Posted : July 25, 2008
Results First Posted : March 21, 2018
Last Update Posted : March 21, 2018
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Cerebrovascular Accident
Deglutition Disorders
Interventions: Device: lingual press
Behavioral: effortful swallowing
Behavioral: natural swallowing
Behavioral: non-oral sham (control) exercise

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
PI is not available, thus the numbers presented are what was initially entered by research team. From data available, only two of the four treatment arms had subjects randomized to. Thus, for the other treatment arms, no data is available, as PI is not available.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lingual Strengthening Isometric Progressive resistance oropharyngeal strengthening for 8 weeks.
Lingual Pressure Norms Normative values for lingual pressures

Participant Flow:   Overall Study
    Lingual Strengthening   Lingual Pressure Norms
STARTED   11   72 
COMPLETED   11   72 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PI is not available, therefore, no data is available for reporting in this section.Efforts to retrieve data were unsuccessful.

Reporting Groups
  Description
Lingual Strengthening Isometric Progressive resistance oropharyngeal strengthening for 8 weeks.
Lingual Pressure Norms Normative values for lingual pressures
Total Total of all reporting groups

Baseline Measures
   Lingual Strengthening   Lingual Pressure Norms   Total 
Overall Participants Analyzed 
[Units: Participants]
 0   0   0 


  Outcome Measures

1.  Primary:   Isometric Lingual Pressure   [ Time Frame: 8 weeks ]

2.  Primary:   Maximum Isometric Tongue Pressure   [ Time Frame: 16 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. JoAnne Robbins
Organization: VAHSRD
phone: 608-256-1901 ext 11697
e-mail: bert.landreth@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00722111     History of Changes
Other Study ID Numbers: C4796-R
First Submitted: July 23, 2008
First Posted: July 25, 2008
Results First Submitted: October 17, 2013
Results First Posted: March 21, 2018
Last Update Posted: March 21, 2018