Anterior Cervical Discectomy and Fusion (ACDF) - Behavioral Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Proactive pharyngeal-laryngeal Exercise Program, Premier Protein Clear ® High Protein, Hydration Counseling.
- Who it may be relevant to
- Registry conditions: Dysphagia. Basic parameters: 21 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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. .
Interventions
- Behavioral 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 - Dietary supplement 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. - Behavioral 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.
Primary outcome measures
- Change in pharyngeal constriction [Time frame: Baseline, 6 weeks post-op]
- Change in pharyngeal shortening [Time frame: Baseline, 6 weeks post-op]
- Change in Dysphagia Score measured by The Hospital for Special Surgery Dysphagia and Dysphonia Inventory (HSS-DDI) [Time frame: Baseline, 6 weeks post-op]
Secondary outcome measures (2)
- Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Ratings [Time frame: Baseline, 6 weeks post-op]
- Change in Dysphonia Score measured by The Hospital for Special Surgery Dysphagia and Dysphonia Inventory (HSS-DDI) [Time frame: Baseline, 6 weeks post-op]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT06520579 · 24-00667