Effectivity of P1821, a Novel Tongue Strengthening and Endurance Enhancing Speech Flow Exercise
調査の概要
詳細な説明
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).
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Matthew Quitto II
- 電話番号:917-342-2895
- メール:dream@dreamholdingsllc.com
研究場所
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Florida
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Naples、Florida、アメリカ、34119
- N/A - Remote Study
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コンタクト:
- Matthew Quitto II
- 電話番号:917-342-2895
- メール:dream@dreamholdingsllc.com
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:P1821 #1
P1821 interventions are administered once daily over a period of fourteen days.
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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.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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P1821
時間枠:From enrollment to the end of treatment at 2 weeks.
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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.
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From enrollment to the end of treatment at 2 weeks.
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P1821
時間枠:From enrollment to the end of treatment at 2 weeks.
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Compare the number of participants experiencing treatment-related adverse events versus those with positive treatment outcomes.
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From enrollment to the end of treatment at 2 weeks.
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Suter VG, Bornstein MM. Ankyloglossia: facts and myths in diagnosis and treatment. J Periodontol. 2009 Aug;80(8):1204-19. doi: 10.1902/jop.2009.090086.
- Belmehdi A, Harti KE, Wady WE. Ankyloglossia as an oral functional problem and its surgical management. Dent Med Probl. 2018 Apr-Jun;55(2):213-216. doi: 10.17219/dmp/85708.
- Binger C, Ragsdale J, Bustos A. Language Sampling for Preschoolers With Severe Speech Impairments. Am J Speech Lang Pathol. 2016 Nov 1;25(4):493-507. doi: 10.1044/2016_AJSLP-15-0100.
- Potter NL, Nievergelt Y, VanDam M. Tongue Strength in Children With and Without Speech Sound Disorders. Am J Speech Lang Pathol. 2019 May 27;28(2):612-622. doi: 10.1044/2018_AJSLP-18-0023. Epub 2019 Feb 28.
- Lalakea ML, Messner AH. Ankyloglossia: the adolescent and adult perspective. Otolaryngol Head Neck Surg. 2003 May;128(5):746-52. doi: 10.1016/S0194-59980300258-4.
- Wang J, Yang X, Hao S, Wang Y. The effect of ankyloglossia and tongue-tie division on speech articulation: A systematic review. Int J Paediatr Dent. 2022 Mar;32(2):144-156. doi: 10.1111/ipd.12802. Epub 2021 May 22.
- Wei EX, Tunkel D, Boss E, Walsh J. Ankyloglossia: Update on Trends in Diagnosis and Management in the United States, 2012-2016. Otolaryngol Head Neck Surg. 2020 Nov;163(5):1029-1031. doi: 10.1177/0194599820925415. Epub 2020 May 19.
- Walsh J, Tunkel D. Diagnosis and Treatment of Ankyloglossia in Newborns and Infants: A Review. JAMA Otolaryngol Head Neck Surg. 2017 Oct 1;143(10):1032-1039. doi: 10.1001/jamaoto.2017.0948.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。