Dysphagia After Anterior Cervical Spine Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04855838|
Recruitment Status : Recruiting
First Posted : April 22, 2021
Last Update Posted : November 14, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Dysphagia Cervical Spinal Cord Injury||Device: Oral neuromuscular training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Impaired Swallowing Function After Anterior Cervical Spine Surgery- Incidence, Long-term Effect on Nutrition and Effect of Oral Neuromuscular Training|
|Actual Study Start Date :||December 17, 2020|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||December 31, 2024|
Experimental: Intervention group
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
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.
No Intervention: Control group
Traditional compensatory swallowing training under 8 weeks with start 4 (±1) weeks post-operation.
- Dysphagia severity [ Time Frame: 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.
- Swallowing ability [ Time Frame: At start, at 4 weeks into the training, at end of treatment (after 8 weeks) and 12 ± 3 months post-intervention ]Change in swallowing ability measured by the FOIS (functional oral intake scale)
- Swallowing related quality of life [ Time Frame: At start, at end of treatment (after 8 weeks) and 12 ± 3 months post-intervention ]Change in quality of life related to swallowing measured by the SWAL-QOL questionnaire.
- Nutritional status [ Time Frame: At start, at end of treatment (after 8 weeks) and 12 ± 3 months post-intervention ]Changes in nutritional status measured by the NRS-2002
- Nutritional and metabolic status [ Time Frame: At start, at end of treatment (after 8 weeks) and 12 ± 3 months post-intervention ]Changes in nutritional status measured by blood samples (i.e., levels of Albumin, levels of Leptin, Ghrelin and Adiponektin and also metabolites as ketone bodies)
- The frequency of pneumonia [ Time Frame: At start, at end of treatment (after 8 weeks) and 12 ± 3 months post-intervention ]The frequency of pneumonia will be will be registered and compared between the intervention and control group.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04855838
|Contact: Patricia Hägglund, PhD/SLPfirstname.lastname@example.org|
|Contact: Thorbjörn Holmlund, PhD/MDemail@example.com|
|University Hospital of Umeå||Recruiting|
|Contact: Patricia Hägglund, PhD/SLP firstname.lastname@example.org|
|Principal Investigator:||Patricia Hägglund, PhD/SLP||Umeå University|
|Responsible Party:||Umeå University|
|Other Study ID Numbers:||
|First Posted:||April 22, 2021 Key Record Dates|
|Last Update Posted:||November 14, 2022|
|Last Verified:||November 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Anterior cervical spine surgery
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Digestive System Diseases