Condition category
Digestive System
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
20/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Trudi Minns

ORCID ID

Contact details

Regional Rehabilitation Unit
North West London Hospitals NHS Trust
Northwick Park Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0515163804

Study information

Scientific title

Fibreoptic endoscopic evaluation of swallowing (FEES): Therapy or Assessment

Acronym

Study hypothesis

The hypothesis is that visual & verbal feedback improves the ability of participants to correctly perform specific movements within the pharynx to command. In addition to this I am hypothesising that FEES is a valuable therapeutic tool with regards to comfort, acceptability, time and resources. To date there is no documented evidence supporting the use of Nasendoscopy as a therapeutic tool, despite the obvious clinical benefits.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Diagnostic

Patient information sheet

Condition

Digestive System: Deglutition disorders

Intervention

Group 1 Participants of the study will be assigned to one of two groups. All participants will be given information about the anatomy of the pharynx and larynx. This will be done using diagrams. With the aid of the diagram, the participant will then be given information about the precise target movements expected of them. These include: Nasopharyngeal closure, tongue base reaction, vocal fold adduction and the posterior pharyngeal wall. The scope will then be passes transnasally to enable three views the nasopharyngeal port, the pharynx and the larynx.

Participants randomised to group 2 will be positioned to allow viewing of their anatomy. The whole assessment process will be videotaped to allow for inter-rate reliability to be established. The participant will be instructed to attempt to each movement in turn and they will be given 3 minutes to perfect this movement. The participant will then be instructed to attempt to perform the movement 5 times consecutively. The movement will be scored as present or absent and a score out of 5 will be given. Group 2 participants will be scoped as before to allow the therapist full view of the movements achieved in the pharynx and this that are not. The participant will not however be able to view the monitor. The participants in this group will receive the same amount of feedback that would normally be available for patients receiving therapy with out the help of nasendoscopy. The investigator will provide them with information about the target movements. Group 2 participants will be given a practice period of 3 minutes per movement. The participant will then be asked to perform the target movements 5 times and the researcher will record the consistency with which they are achieved.

As with group 1, all the assessment results will be recorded on to videotape. The assessment time in total should not exceed 20 minutes. Analysis of the results will be achieved using a chi squared statistical test.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Measurement of the target movement. Assessment as to whether or not these movements have been achieved will be rate by the principal investigator and the data will be re-rated by a further therapist skilled in this area

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/2002

Overall trial end date

31/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Participants will be selected and randomly assigned into two groups. Each group will consist of 10 healthy volunteers with no history of swallowing difficulties. Participants will be recruited predominantly from staff working at Northwick Park Hospital.

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

1. Patients under 18
2. Patients with swallowing difficulties

Recruitment start date

01/07/2002

Recruitment end date

31/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Northwick Park Hospital
Harrow
HA1 3UJ
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

North West London Hospitals NHS Trust (UK), NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes