Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04855838

Impaired Swallowing Function After Anterior Cervical Spine Surgery: Incidence, Long-term Nutritional Effects, and Oral Neuromuscular Training Evaluation

Led by Umeå University · Updated on 2024-12-11

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

Umeå University

Lead Sponsor

U

University Hospital, Umeå

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying impaired swallowing (dysphagia) following anterior cervical spine surgery (ACSS) performed between the C2 and Th1 spinal levels due to trauma. The study aims to understand how often dysphagia occurs after this surgery, its long-term impact on nutritional health over about 12 months, and to test a new rehabilitation method for those with swallowing difficulties after surgery. The study has two parts. The first part observes patients' swallowing function using a flexible video endoscopic evaluation (FEES) within 14 days after surgery and again 2-3 weeks later, alongside nutritional assessments including clinical tests and blood samples. Patients receive conventional care like postural adjustments and swallowing exercises. Those with ongoing swallowing problems at about 4 weeks post-surgery can join the second part, a randomized trial comparing standard care to an 8-week oral neuromuscular training program using a special oral device. Swallowing function, quality of life, and nutritional status are measured at multiple points during and after treatment. Participants will be assessed multiple times: swallowing function and nutritional status are evaluated early after surgery, at treatment start, mid-treatment, end of treatment, and around 12 months later. Assessments include clinical tests, blood samples, and quality of life questionnaires. All procedures take place at the University Hospital, and clinical data such as age, sex, injury severity, and hospital stay details are recorded. Evaluators measuring swallowing function are blinded to treatment groups to ensure unbiased results.

CONDITIONS

Brief Title

Dysphagia After Anterior Cervical Spine Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who have undergone anterior cervical spine surgery between C2 and Th1 levels due to trauma at the University Hospital of Umeå
  • Swallowing dysfunction confirmed by flexible endoscopic evaluation at about 4 weeks post-operation for part 2
  • Adults aged 18 years or older
Not Eligible

You will not qualify if you...

  • Patients under 18 years of age
  • Known swallowing problems before the trauma or injury
  • Brainstem injury visible on CT or MRI
  • Severe brain damage

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Initial swallowing function assessment within 14 days after surgery

Monitoring

Duration - Approximately 2 to 3 weeks after initial assessment

Participants who have swallowing dysfunction are re-assessed approximately 4 weeks after surgery to evaluate spontaneous recovery while receiving conventional care.

1 follow-up visit (in-person) around 4 weeks post-operation

Treatment

Duration - 8 weeks

Participants with persistent swallowing dysfunction are randomly assigned to 8 weeks of either oral neuromuscular training or conventional compensatory swallowing training starting around 4 weeks post-operation.

Swallowing assessments at start, 4 weeks into treatment, and end of treatment; oral neuromuscular training performed three times daily

Follow-up

Duration - 12 ± 3 months after surgery

Participants have long-term assessments of swallowing function, quality of life, and nutritional status 12 ± 3 months after surgery to evaluate lasting effects.

1 visit (in-person) for long-term evaluation

Trial Site Locations

Total: 1 location

1

University Hospital of Umeå

Umeå, Sweden

Actively Recruiting

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Research Team

P

Patricia Hägglund, PhD/SLP

T

Thorbjörn Holmlund, PhD/MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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