Study of Tongue Strengthening for Swallowing Problems

University of Wisconsin (UW)

Status: Completed

Conditions: Dysphagia

Treatments: Behavioral: Isometric Progressive Resistance Oropharyngeal Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01570023

2011-0518

Details and patient eligibility

About

This study is a multisite, randomized clinical trial to determine the effectiveness of an 8-week rehabilitative exercise regime performed by patients with swallowing problems, termed dysphagia, compared to a control group of patients with swallowing problems who do not exercise, but receive standard clinical care. One hundred male and female patients will take part in this study from eight participating facilities around the country.

Enrollment: 34 patients

Sex: All

Ages: 21 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• referral by a physician for swallowing evaluation because of suspected dysphagia
• complaint of difficulty swallowing
• aspiration or penetration of the laryngeal vestibule with liquids or semisolids OR post-swallow residue visible in the oral cavity, valleculae, or pharynx that is instrumentally documented by a participating SLP during a standard clinical videofluoroscopic swallowing study
• between the ages of 21 and 95
• ability to perform the exercise protocol independently or with the assistance of a caregiver
• physician approval of medical stability to participate
• decision-making capacity to provide informed consent (confirmed through discussion between the participating SLP and the subject's primary physician)

Exclusion criteria

• degenerative neuromuscular disease
• poorly controlled psychosis
• patient unable to complete the exercise program
• allergy to barium (used in videofluoroscopic swallowing assessment)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Standard Clinical Care

No Intervention group

Description:

Standard swallowing intervention is that which is identified by the SLP as appropriate to treat the patient's dysphagia and is in common clinical practice. Such treatment would consist of dietary or postural compensatory strategies (i.e., chin down posture while swallowing).

Standard Clinical Care Plus Isometric Lingual Exercise

Experimental group

Description:

Standard Clinical Care Plus 8-week Isometric Lingual Exercise Regimen. The isometric tongue exercises will be completed using the Madison Oral Strengthening Therapeutic (MOST) device. Baseline maximum lingual pressure will be obtained at the anterior and posterior sensors independently by gathering two sets of data (3 MOST device trials) at each site (anterior and posterior) that differ by less that 5%. During week one of the regimen, the target value of each repetition will be 60% of the maximum baseline pressure. For the remaining seven weeks of the program, the target value will be increased to 80% of the maximum. At weeks three, five, and seven, the baseline will be re-measured by phone and the 80% target value re-calculated.

Treatment:

Behavioral: Isometric Progressive Resistance Oropharyngeal Therapy