Ankyloglossia, Impairment of Speech, Slurred Speech
Conditions
Keywords
Tongue-strengthening self-exercises (TSsE), Tongue strength, Home-based exercise, Self-exercise
Brief summary
The P1821 initiative constitutes an innovative intervention specifically engineered to enhance tongue muscular strength and endurance. The primary objective of this research study is to ascertain whether the integration of a proactive tongue strengthening exercise regimen, utilizing a Non-Significant Risk (NSR) Device, contributes to an observable improvement in speech fluency.
Detailed description
P1821 specifically targets the muscles in the tongue. These areas are part of the tongue's movable section, known for their great flexibility and ability to perform complex movements. The tongue plays a crucial role in speech production. Weakness in its muscles can lead to difficulties in speaking clearly and distinctly. The tongue is a highly mobile group of muscles, richly supplied with blood and nerves. The tongue's remarkable ability to move in all directions stems from the unique arrangement of its muscle fibers, which is unlike any other muscle in the body. These fibers run in three dimensions: From front to back, from the sides to the middle, and from top to bottom. This unique structure allows the tongue to perform a variety of movements, including: Getting longer and shorter. The tongue is the only muscle in the body that can be actively lengthened, not just shortened. When the vertical and horizontal fibers contract simultaneously, the tongue becomes narrower and longer, enabling it to be extended. Changing its position: Additional muscles can alter the tongue's overall position by pulling it from the front (from the lower jaw), from below and behind (from the hyoid bone), and from above and behind (from the base of the skull).
Interventions
DEVICEP1821
The P1821 intervention is distinguished by its independence from pharmaceutical agents and electronic devices. Its foundational mechanism is predicated exclusively on the physiological principles of muscle resistance training, thereby offering a non-pharmacological and non-invasive therapeutic approach.
Sponsors
Dream Video LLC
Dream Holdings Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All study participants will get the same intervention.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Can read and write * Willing and able to follow the requirements of the protocol
Exclusion criteria
* Previously seen and treated by speech and language pathologist for dysphagia or dysarthria for non-head and neck cancer causes * Medical instability, restlessness, or other factors that would compromise data acquisition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| P1821 | From enrollment to the end of treatment at 2 weeks. | The primary key performance indicator will be the proportion of study participants who demonstrate statistically significant and measurable improvements in their speaking ability following the completion of the two-week treatment protocol within P1821. This metric is crucial for evaluating the efficacy of the intervention and will be assessed through standardized linguistic and speech pathology evaluations. |
Countries
United States
Contacts
CONTACTMatthew Quitto II
Outcome results
None listed