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Идёт набор NCT06520579

Anterior Cervical Discectomy and Fusion (ACDF) - Behavioral Intervention

Без фазы С лечением Dysphagia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Proactive pharyngeal-laryngeal Exercise Program, Premier Protein Clear ® High Protein, Hydration Counseling.
Кому может быть актуально
Состояния в реестре: Dysphagia. Базовые параметры: 21 лет — 99 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Pilot Proof of Concept, Prospective Cohort, Single-Center Study on the Effects of Behavioral Intervention on Swallowing and Voice Outcomes After Anterior Cervical Discectomy and Fusion (ACDF) Surgery

Обзор

This study will prospectively recruit and enroll patients undergoing primary Anterior Cervical Discectomy and Fusion (ACDF) surgeries at NYU Langone. Participants will undergo pre-operative and six-week post-operative swallowing assessment using videofluoroscopy (VFSS). Acoustic voice samples and Patient Reported Outcome Measures (PROMs) for swallowing and voice will also be collected. Beginning one-week before surgery participants will begin a behavioral health program that will be continued for six-weeks after surgery. The primary goal of this study will be to determine whether a preventative behavioral health program improves instrumental measures of swallowing and voice six-weeks after ACDF surgery. .

Вмешательства

  • Поведенческое Proactive pharyngeal-laryngeal Exercise Program
    This program consists of daily proactive pharyngeal-laryngeal exercises and weekly sessions with a speech-language pathologist post surgery. One week prior to surgery participants will begin daily proactive pharyngeal-laryngeal exercises and continue these daily exercises for 6 weeks post surgery. Beginning approximately one week after surgery, participants will meet with the speech-language pathologist. Sessions will occur weekly, for approximately 6 weeks, and will last approximately 45 minute
  • Пищевая добавка Premier Protein Clear ® High Protein
    Premier Protein Clear ® High Protein (20 grams of protein and 90 calories per 16.9 oz. drink) 1 drink daily for 7 weeks.
  • Поведенческое Hydration Counseling
    Daily hydration goals are based on recommended guidelines for adults, by gender, from The United States National Academy of Medicine (US NAM) and the European Food Safety Authority (ESFA) (\~2.0 L/day for women; \~2.5 L/day for men of fluid intake, accounting for 20% daily fluid intake from food sources). Patients will be required to track via paper log whether they met their hydration goals daily.

Первичные конечные точки

  • Change in pharyngeal constriction [Срок оценки: Baseline, 6 weeks post-op]
  • Change in pharyngeal shortening [Срок оценки: Baseline, 6 weeks post-op]
  • Change in Dysphagia Score measured by The Hospital for Special Surgery Dysphagia and Dysphonia Inventory (HSS-DDI) [Срок оценки: Baseline, 6 weeks post-op]
Вторичные конечные точки (2)
  • Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Ratings [Срок оценки: Baseline, 6 weeks post-op]
  • Change in Dysphonia Score measured by The Hospital for Special Surgery Dysphagia and Dysphonia Inventory (HSS-DDI) [Срок оценки: Baseline, 6 weeks post-op]

Критерии участия

Критерии включения

  • Able and willing to sign consent form to participate in the study.
  • Age between 21- 99 years.
  • Scheduled to undergo ACDF surgery with surgeons in the departments of Neurosurgery or Orthopedic Surgery at NYU Langone.

Критерии исключения

  • Patients with non-degenerative spine conditions, such as trauma, tumors, infection, radiation, and diabetes.
  • Patients with prior posterior-approach cervical spine procedures.
  • Patients undergoing ACDF revision procedures.
  • Patients who report a pre-existing dysphagia as the result of a neurological deficit or disorder, head and neck cancer treatment, and/or muscular condition.
  • Pregnancy. Female subjects must confirm they are not pregnant before enrolling in the study.
  • Patients with chronic kidney disease, limiting their ability to consume high levels of protein.
  • Patients with known allergies to ingredients listed in Premier Protein Clear drinks.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • NYU Langone Health — New York

Идентификаторы

NCT: NCT06520579 · 24-00667

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗