Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000537257
Ethics application status
Not yet submitted
Date submitted
28/06/2009
Date registered
3/07/2009
Date last updated
19/11/2019
Date data sharing statement initially provided
19/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of exercises on suprahyoid muscles and hyoid movement during swallowing in healthy individuals: investigation by ultrasound
Scientific title
The effects of exercises on suprahyoid muscles and hyoid movement during swallowing in healthy individuals: investigation by ultrasound
Secondary ID [1] 299851 0
nil known
Universal Trial Number (UTN)
Trial acronym
none
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 237110 0
dysphagia 237130 0
Condition category
Condition code
Neurological 237438 237438 0 0
Other neurological disorders
Stroke 237452 237452 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be assigned to one of two exercise groups: modified head-lift manoeuvre (group one) or a placebo treatment which is known to not influence swallowing physiology (group two).

Exercise programme:
The instructions for each participant will vary depending on the exercise group they have been assigned to. Procedures for the two groups will be as follows:

Group 1 : Modified Head-lift manoeuvre
Participants assigned to the modified head-lift manoeuvre exercise group will be instructed to sit in an upright position. A theraband (elastic exercise band) will be fixed around their head. They will be instructed to open their mouth against the resistance of the theraband and hold it for one minute, and then rest one minute. The sustained jaw-opening against resistance will be repeated a total of 3 times. Then they will be instructed to to briefly open their mouth against the resistance. They will repeat this brief jaw-opening 30 times. Verbal feedback will be provided throughout regarding the mastery of task performance.


Each participant will then be given an exercise record sheet to take home, and instructed to carry out the practiced exercise 3 times per day, 5 days per week for 6 weeks. Each of the 3 daily sessions will involve 33 repetitions of the assigned exercise (30 rapid ball squeezes and 3 sustained squeezes for the placebo group, and 33 jaw-openings for the modified head-lift group).

Intervention tasks will be supervised by research clinician (speech language therapist)
Intervention code [1] 236831 0
Rehabilitation
Comparator / control treatment
Group 2: Placebo exercise
Participants assigned to the placebo exercise group will carry out an exercise protocol outlined by Shaker and colleagues. They will be given a commercially available rubber ball and will be instructed to squeeze the ball in their right hand for one minute. The sustained ball squeeze will be repeated a total of 3 times. They will then be instructed to briefly squeeze the ball and then relax. They will repeat this brief exercises 30 times. Verbal feedback will be provided throughout regarding the mastery of task performance. The ball squeezing task serves as a placebo by engaging the patient in a smiilar treatment protocol to the experimental task with no indication of physiologic effect. This task has been used in prior swallowing research as a placebo.


Each participant will then be given an exercise record sheet to take home, and instructed to carry out the practiced exercise 3 times per day, 5 days per week for 6 weeks. Each of the 3 daily sessions will involve 33 repetitions of the assigned exercise (30 rapid ball squeezes and 3 sustained squeezes for the placebo group, and 33 jaw-openings for the modified head-lift group).

Intervention tasks will be supervised by research clinician (speech language therapist)
Control group
Placebo

Outcomes
Primary outcome [1] 238237 0
% increase in maximal anterior hyoid movement during swallowing as measured with ultrasound
Timepoint [1] 238237 0
pre-treatment and after 2, 4, 6 weeksof treatment
Primary outcome [2] 238254 0
% change in two dimensional muscle size as measured by ultrasound
Timepoint [2] 238254 0
pre-treatment and after 2, 4,6 weeks of treamtent
Secondary outcome [1] 244609 0
nil
Timepoint [1] 244609 0
nil

Eligibility
Key inclusion criteria
healthy adults aged 21+
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
history of neurological or swallowing impairment; injury or illness to head and neck.

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)
After a potential participant has passed screening procedures for inclusion in the study and signed informed consent the researcher who is providing the treatment will contact the primary investigator who will provide the treatment group assignment. Therefore allocation involved contacting the holder of the allocation schedule who was 'off-site' or at a central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated randomisation table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
15/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment outside Australia
Country [1] 1860 0
New Zealand
State/province [1] 1860 0
Canterbury
Country [2] 1861 0
New Zealand
State/province [2] 1861 0
Christchurch

Funding & Sponsors
Funding source category [1] 237221 0
Self funded/Unfunded
Name [1] 237221 0
Maggie-Lee Huckabee
Country [1] 237221 0
New Zealand
Primary sponsor type
University
Name
University of Canterbury
Address
Private Bag 4800
Christchurch
Country
New Zealand
Secondary sponsor category [1] 4713 0
None
Name [1] 4713 0
Address [1] 4713 0
Country [1] 4713 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239319 0
Upper South A Health and Disability Ethics Committee
Ethics committee address [1] 239319 0
Ethics committee country [1] 239319 0
New Zealand
Date submitted for ethics approval [1] 239319 0
06/07/2009
Approval date [1] 239319 0
Ethics approval number [1] 239319 0
Ethics committee name [2] 239338 0
Ethics committee address [2] 239338 0
Ethics committee country [2] 239338 0
Date submitted for ethics approval [2] 239338 0
06/07/2009
Approval date [2] 239338 0
Ethics approval number [2] 239338 0

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

Contacts
Principal investigator
Name 29808 0
Address 29808 0
Country 29808 0
Phone 29808 0
Fax 29808 0
Email 29808 0
Contact person for public queries
Name 13055 0
Maggie-Lee Huckabee
Address 13055 0
Van der Veer Institute
66 Stewart St
Christchurch
8011
Country 13055 0
New Zealand
Phone 13055 0
6433786070
Fax 13055 0
Email 13055 0
[email protected]
Contact person for scientific queries
Name 3983 0
Maggie-lee Huckabee
Address 3983 0
Van der Veer Institute
66 STewart St
Christchurch
8011
Country 3983 0
New Zealand
Phone 3983 0
6433786070
Fax 3983 0
Email 3983 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.