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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in pharyngeal constriction
研究概览
简要总结
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. .
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in pharyngeal constriction
时间窗: Baseline, 6 weeks post-op
Outcome measure will be assessed using 2D lateral videofluoroscopic images will be used to measure pharyngeal constriction pre and post intervention
Change in Dysphagia Score measured by The Hospital for Special Surgery Dysphagia and Dysphonia Inventory (HSS-DDI)
时间窗: Baseline, 6 weeks post-op
The HSS-DDI consists of 31 patient-reported questions to assess Dysphagia and Dysphonia. Of the 31 questions, 20 ask about swallowing using a 5-point scoring method (1-5). Scores range from 20-100, where lower scores indicate dysphagia.
Change in pharyngeal shortening
时间窗: Baseline, 6 weeks post-op
Outcome measure will be assessed using 2D lateral videofluoroscopic images will be used to measure pharyngeal shortening pre and post intervention
次要结局
- Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Ratings(Baseline, 6 weeks post-op)
- Change in Dysphonia Score measured by The Hospital for Special Surgery Dysphagia and Dysphonia Inventory (HSS-DDI)(Baseline, 6 weeks post-op)