Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001071415p
Ethics application status
Not yet submitted
Date submitted
20/07/2025
Date registered
1/10/2025
Date last updated
1/10/2025
Date data sharing statement initially provided
1/10/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of Kinesiology taping for swallowing difficulties in people recovering from brain tumour surgery
Scientific title
The effectiveness of Kinesiology Taping on Dysphagia in brain tumor survivors after neurosurgery: Randomized controlled trial
Secondary ID [1] 314947 0
Nil known
Universal Trial Number (UTN)
U1111-1318-9830
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysphagia 338263 0
Condition category
Condition code
Cancer 334560 334560 0 0
Brain
Oral and Gastrointestinal 335020 335020 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention
The control group will receive standard dysphagia care, while the intervention group will receive both standard and kinesiology tape applications.
Routine dysphagia care consists of oral exercises (e.g., repeated dry swallowing five consecutive times, followed by a 10-second rest period. This sequence will be repeated a total of 10 times), compensatory techniques (e.g., chin tuck, head rotation, and head tilt), swallowing therapeutic maneuvers (e.g., supraglottic swallowing, super-supraglottic swallow, effortful swallowing, and the Mendelsohn maneuver), and other exercises used to improve swallowing physiology (e.g., the Shaker exercise and Masako maneuver).
This routine will be implemented in one daily session, four days a week, for four weeks. Sessions will last approximately 30 minutes, resulting in 16 sessions.
Sessions will be led by a team of two senior nurses specialized in rehabilitation, experts in dysphagia care, and trained in kinesiology taping application, with more than 10 years of clinical experience.
A 5 cm wide, 0.5 mm thick kinesiology tape will be applied as follows: Participants will sit upright in a chair with their head and neck in a neutral position. The anterior neck will be cleaned with an alcohol swab for optimal tape adhesion. Team members will customize an I-shaped tape and a reverse V-shaped tape. The hyoid bone and thyroid cartilage will be marked with a pen. First, an I-shaped tape will be applied by pulling it downwards to the level of the thyroid notch to wrap around the thyroid cartilage and attach it to the sternum. Second, the team members will attach a reverse V-shaped tape from the hyoid bone to the superior medial surface of the clavicle on both sides. Finally, they will cover the hyolaryngeal complex horizontally to restrict its movement throughout swallowing, ensuring the tape is securely attached.
The tape will be applied daily for 4 weeks with an application at approximately 70-80% tension.

Concomitant treatments and medication
Participants can continue their routine medications for underlying diseases such as hypertension and diabetes. However, the use of additional benzodiazepines, antipsychotics, and anti-epileptics that may impact their swallowing function is permitted only if deemed necessary. If a participant takes medication that could affect their swallowing ability, it will be documented in the case report form.

Adherence to the intervention will be monitored through the number of sessions attended and the percentage of enrolled participants who completed the final program assessments, as recorded in the patient diary.
Intervention code [1] 331548 0
Rehabilitation
Intervention code [2] 331877 0
Treatment: Devices
Comparator / control treatment
The control group will receive standard dysphagia care, while the intervention group will receive both standard and kinesiology tape applications. Standard dysphagia management includes oral–motor exercises, compensatory techniques such as postural adjustments and bolus modification, and swallowing therapeutic maneuvers as clinically indicated. Standard care will be delivered in one daily session, four days per week, for a total duration of four weeks. Sessions will be conducted in a one-on-one, face-to-face format and administered by a rehabilitation nurse. Adherence to the control treatment will be monitored through the number of sessions attended, as recorded in the patient diary.
Control group
Active

Outcomes
Primary outcome [1] 342234 0
Evaluation of Swallowing
Timepoint [1] 342234 0
At baseline T0 and after intervention T1 (at 24 hours after the final session).
Primary outcome [2] 342235 0
Evaluation of Swallowing
Timepoint [2] 342235 0
At baseline T0 and after intervention T1 (at 24 hours after the final session).
Primary outcome [3] 342236 0
Evaluation of Swallowing perception
Timepoint [3] 342236 0
At baseline T0 and after intervention T1 (at 24 hours after the final session).
Secondary outcome [1] 450059 0
enrollment
Timepoint [1] 450059 0
end of treatment - immediately after the final session.
Secondary outcome [2] 450060 0
satisfaction
Timepoint [2] 450060 0
end of treatment - immediately after the final session.
Secondary outcome [3] 450061 0
adverse events
Timepoint [3] 450061 0
end of treatment - immediately after the final session.

Eligibility
Key inclusion criteria
Patients with dysphagia after brain tumor surgery will be included in this study if (a) diagnosis of oropharyngeal dysphagia, confirmed by flexible endoscopic evaluation of swallowing (FEES), (b) a Mini-Mental Status Examination (MMSE) score of 22 or higher, (c) ability to swallow voluntarily, (d) ability to swallow against resistance of tape, and (e) able to communicate with the investigator, to understand and comply with the study procedures.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have (a) dysphagia due to drug toxicity, (b) difficulty with or the inability to trigger a volitional swallow, (c) skin disorders, including allergies associated with taping attachment, (d) developed pneumonia or unstable medical conditions during the study, (e) presence of tracheotomy, (f) known history of progressive neurological disorder (for example, Parkinson’s disease, multiple sclerosis), (g) previously received swallowing therapy, (h) under 18 years of age, and (i) severe cognitive difficulties or significant active psychiatric disorders.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation plan, including allocation groups and follow-up measurements, will be generated using online software that employs a random block sizes method.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (icomputerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics measures of mean, standard deviation, median, minimum, maximum, and range will be used to characterize the sample in terms of sociodemographic characteristics and variables of interest for each group in the study. In addition, boxplots will also be created to show these variables in a graphical format. Subsequently, a repeated measures analysis of variance (ANOVA) will be used to identify the differences between the two groups and evaluate which exhibits better outcomes. The assumptions of the ANOVA will be verified through the Mauchly’s test of sphericity, the Levene test for homogeneity of variances and visual observation of the Q-Q plot.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2026
Actual
Date of last data collection
Anticipated
30/08/2026
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 27244 0
Portugal
State/province [1] 27244 0

Funding & Sponsors
Funding source category [1] 319502 0
University
Name [1] 319502 0
Egas Moniz School of Health & Science.
Country [1] 319502 0
Portugal
Primary sponsor type
University
Name
Egas Moniz School of Health & Science.
Address
Country
Portugal
Secondary sponsor category [1] 321997 0
Hospital
Name [1] 321997 0
Garcia de Orta Hospital
Address [1] 321997 0
Country [1] 321997 0
Portugal

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 318078 0
Egas Moniz CRL Ethical Review Committee
Ethics committee address [1] 318078 0
Ethics committee country [1] 318078 0
Portugal
Date submitted for ethics approval [1] 318078 0
24/10/2025
Approval date [1] 318078 0
Ethics approval number [1] 318078 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 143046 0
Prof Júlio Belo Fernandes
Address 143046 0
Campus Universitário, Quinta da Granja, Monte de Caparica, 2829-511 Caparica
Country 143046 0
Portugal
Phone 143046 0
+351968392976
Fax 143046 0
Email 143046 0
[email protected]
Contact person for public queries
Name 143047 0
Júlio Belo Fernandes
Address 143047 0
Campus Universitário, Quinta da Granja, Monte de Caparica, 2829-511 Caparica
Country 143047 0
Portugal
Phone 143047 0
+351968392976
Fax 143047 0
Email 143047 0
[email protected]
Contact person for scientific queries
Name 143048 0
Júlio Belo Fernandes
Address 143048 0
Campus Universitário, Quinta da Granja, Monte de Caparica, 2829-511 Caparica
Country 143048 0
Portugal
Phone 143048 0
+351968392976
Fax 143048 0
Email 143048 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
A finite period of: 5 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Journal publication or its supplementary materials: Individual participant data that underlie the results reported in the study report (after de-identification) will be available in the journal publication or its supplementary materials.

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.