Ireland
--:--IST
Recruiting Not applicable

Dysphagia After Anterior Cervical Spine Surgery

NCT04855838 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2020-12-17
Last updated
2024-12-11

Condition(s) studied

DysphagiaCervical Spinal Cord Injury

Investigational drug(s) / intervention(s)

Oral neuromuscular training

Oral neuromuscular training: The oral device is used for 30 seconds, three times a day, before meals and implies new possibilities for training of the orofacial and pharyngeal muscles.

Study summary

The purpose of this research project is to investigate the incidence of impaired swallowing (dysphagia) after anterior cervical spine surgery (ACSS) and to study the long-term effect of dysphagia on nutritional status 12 ± 3 months later. Furthermore, to investigate the effect of a new rehabilitation method for dysphagia among individuals with swallowing dysfunction after ACSS.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * All patients enrolled at the University Hospital of Umeå who have undergone ACSS between C2 and Th1 level due to trauma are eligible participants in the first part of the study. * Eligibility criteria to participate in part 2 is swallowing dysfunction on FEES at 4±1-week post-operation Exclusion Criteria: * Patients \<18 years of age * known dysphagia prior to the trauma/injury * affected brainstem that is shown on a CT or MRI * severe brain damage.

Primary outcome measure(s)

  • Dysphagia severity — At start, at 4 weeks into the training, at end of treatment (after 8 weeks) and 12 ± 3 months post-intervention
    Change in swallowing function measured by FEES.

Trial sites (1)

FacilityCityRegionStatus
University Hospital of Umeå Umeå Sweden Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04855838 on ClinicalTrials.gov ↗ ← All trials in Sweden