Dysphagia After Anterior Cervical Spine Surgery

NCT04855838 | Recruiting

• 1 other identifier: 2019-06543
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysphagia; Cervical Spinal Cord Injury

Keywords

Swallowing disorder; Anterior cervical spine surgery; Intervention; Incidens; Nutritional status

Outcome Measures

Primary Outcomes (1)

• Dysphagia severity

  Change in swallowing function measured by FEES.

  At start, at 4 weeks into the training, at end of treatment (after 8 weeks) and 12 ± 3 months post-intervention

Secondary Outcomes (5)

• Swallowing ability

  At start, at 4 weeks into the training, at end of treatment (after 8 weeks) and 12 ± 3 months post-intervention

• Swallowing related quality of life

  At start, at end of treatment (after 8 weeks) and 12 ± 3 months post-intervention

• Nutritional status

  At start, at end of treatment (after 8 weeks) and 12 ± 3 months post-intervention

• Nutritional and metabolic status

  At start, at end of treatment (after 8 weeks) and 12 ± 3 months post-intervention

• The frequency of pneumonia

  At start, at end of treatment (after 8 weeks) and 12 ± 3 months post-intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Intensive training with oral neuromuscular device (intervention group) and traditional compensatory swallowing training under 8 weeks with start 4 (±1) weeks post-operation.

Device: Oral neuromuscular training

Control group

NO INTERVENTION

Traditional compensatory swallowing training under 8 weeks with start 4 (±1) weeks post-operation.

Interventions

Oral neuromuscular training DEVICE

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umeå University: lead
• University Hospital, Umeå: collaborator

Study Sites (1)

University Hospital of Umeå

Umeå, Sweden

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Patricia Hägglund, PhD/SLP

  Umeå University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Hägglund, PhD/SLP

CONTACT

+46907850000; patricia.hagglund@umu.se

Thorbjörn Holmlund, PhD/MD

CONTACT

+46907850000; thorbjorn.holmlund@umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 22, 2021
• Study Start: December 17, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)