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Trial registered on ANZCTR


Registration number
ACTRN12621000465853
Ethics application status
Approved
Date submitted
16/02/2021
Date registered
20/04/2021
Date last updated
20/04/2021
Date data sharing statement initially provided
20/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Does increasing the amount of swallowing therapy improve outcomes for adults with swallowing problems after stroke?
Scientific title
The effect of increasing the dosage of swallowing intervention on oral intake in adult inpatients with post-stroke dysphagia
Secondary ID [1] 302689 0
Nil known
Universal Trial Number (UTN)
U1111-1260-7010
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysphagia 319605 0
Condition category
Condition code
Physical Medicine / Rehabilitation 317546 317546 0 0
Speech therapy
Stroke 317547 317547 0 0
Ischaemic
Stroke 317548 317548 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Based on impairments identified during assessment, participants will be prescribed individualised swallowing exercises by their treating speech pathologist. Exercises will target coordination and range-of-movement of oral muscles, strengthening of pharyngeal muscles and swallow-specific exercises. Exercises may include Shaker head lift, chin tuck against resistance, lip and tongue exercises and Mendelsohn maneuver. The target number of repetitions of each exercise per session will be double the mean number of repetitions of each exercise per session (± 1 standard deviation) in the control group (identified from medical record audit).

Participants in the experimental group will receive daily rehabilitative swallowing intervention (i.e. five days per week). Participants will be seen by their usual treating speech pathologist for individual face-to-face sessions in an inpatient rehabilitation hospital. They will also receive additional face-to-face individual swallowing intervention sessions provided by either the lead researcher (speech pathologist with seven years' experience) or trained research assistants/volunteers, so that they are seen five days per week in total. The additional swallowing intervention sessions will consist of the same exercises and target dosages as sessions with their treating speech pathologist.

Intervention will be ceased when participants return to their premorbid diet and fluids; or if they are discharged from the inpatient rehabilitation ward (whichever comes first).

Data on exercises, dosage and adherence will be collected (i.e. type of exercises, number and length of sessions, and number of exercise repetitions). If participants are unable to complete the target number of sessions or repetitions, reasons why will be documented. The exercises and dosages prescribed in therapy sessions will be provided as a home exercise program to participants and their caregivers, along with an exercise record and a hand-held tally counter. Participants or family members will be asked to count and record all repetitions practised outside of therapy sessions.
Intervention code [1] 318972 0
Rehabilitation
Comparator / control treatment
A medical record audit was conducted with 41 patients with post-stroke dysphagia who were admitted to the inpatient rehabilitation ward at Braeside Hospital between March 2018-September 2019. These patients received individualised rehabilitative swallowing exercises which included exercises targeting coordination and range-of-movement of oral muscles, strengthening of pharyngeal muscles and swallow-specific exercises. On average, participants received 52 exercise repetitions per session and two-three swallowing intervention sessions per week.
Control group
Historical

Outcomes
Primary outcome [1] 325590 0
Change in Functional Oral Intake Score (FOIS)
Timepoint [1] 325590 0
Baseline, immediately after intervention (i.e. on return to premorbid diet/fluids, or at discharge; primary timepoint) and 3 months post commencement of intervention
Primary outcome [2] 325591 0
Number of participants who returned to premorbid diet and fluids assessed through medical record audit or patient interview
Timepoint [2] 325591 0
At conclusion of study (primary timepoint) and 3 months post commencement of intervention
Primary outcome [3] 325592 0
Number of days before participants returned to premorbid diet and fluids assessed through medical record audit
Timepoint [3] 325592 0
Immediately after intervention (i.e. on return to premorbid diet/fluids)
Secondary outcome [1] 388475 0
Pharyngeal residue measured using Eisenhuber pharyngeal residue rating scale during videofluoroscopic swallowing studies
Timepoint [1] 388475 0
Baseline and immediately after intervention (i.e. on return to premorbid diet/fluids, or at discharge)
Secondary outcome [2] 388476 0
Anterior hyoid movement measured in millimetres during videofluoroscopic swallowing studies
Timepoint [2] 388476 0
Baseline and immediately after intervention (i.e. on return to premorbid diet/fluids, or at discharge)
Secondary outcome [3] 388477 0
Superior hyoid movement measured in millimetres during videofluoroscopic swallowing studies
Timepoint [3] 388477 0
Baseline and immediately after intervention (i.e. on return to premorbid diet/fluids, or at discharge)
Secondary outcome [4] 388478 0
Width of suprahyoid muscles in millimetres measured using ultrasonography
Timepoint [4] 388478 0
Baseline and immediately after intervention (i.e. on return to premorbid diet/fluids, or at discharge)
Secondary outcome [5] 388479 0
Maximum pressure of lips measured using Iowa Oral Performance Instrument (IOPI)
Timepoint [5] 388479 0
Baseline and immediately after intervention (i.e. on return to premorbid diet/fluids, or at discharge)
Secondary outcome [6] 391955 0
Maximum pressure of anterior tongue measured using Iowa Oral Performance Instrument (IOPI)
Timepoint [6] 391955 0
Baseline and immediately after intervention (i.e. on return to premorbid diet/fluids, or at discharge)
Secondary outcome [7] 391957 0
Maximum pressure of posterior tongue measured using Iowa Oral Performance Instrument (IOPI)
Timepoint [7] 391957 0
Baseline and immediately after intervention (i.e. on return to premorbid diet/fluids, or at discharge)
Secondary outcome [8] 391961 0
Qualitative data on experiences and perspectives of patients undertaking an increased dosage of swallowing intervention gathered through semi-structured patient interviews
Timepoint [8] 391961 0
Immediately after intervention (i.e. on return to premorbid diet/fluids, or at discharge)
Secondary outcome [9] 391962 0
Qualitative data on experiences and perspectives of clinicians undertaking an increased dosage of swallowing intervention gathered through a semi-structured focus group
Timepoint [9] 391962 0
At conclusion of the case-control study
Secondary outcome [10] 393022 0
Peak amplitudes of suprahyoid muscle activation during swallowing measured using surface electromyography (sEMG)
Timepoint [10] 393022 0
Baseline and immediately after intervention (i.e. on return to premorbid diet/fluids, or at discharge)
Secondary outcome [11] 393023 0
Swallowing-related quality of life assessed using the Dysphagia Handicap Index
Timepoint [11] 393023 0
At baseline, immediately after intervention (i.e. upon return to premorbid diet/fluids, or at discharge; primary timepoint), and 3 months post commencement of intervention
Secondary outcome [12] 394279 0
Level of penetration and aspiration on thin fluids measured using Penetration-Aspiration Score during videofluoroscopic swallowing studies
Timepoint [12] 394279 0
Baseline and immediately after intervention (i.e. on return to premorbid diet/fluids, or at discharge)
Secondary outcome [13] 394280 0
Level of penetration and aspiration on thickened fluids measured using Penetration-Aspiration Score during videofluoroscopic swallowing studies
Timepoint [13] 394280 0
Baseline and immediately after intervention (i.e. on return to premorbid diet/fluids, or at discharge)
Secondary outcome [14] 394281 0
Level of penetration and aspiration on food measured using Penetration-Aspiration Score during videofluoroscopic swallowing studies
Timepoint [14] 394281 0
Baseline and immediately after intervention (i.e. on return to premorbid diet/fluids, or at discharge)

Eligibility
Key inclusion criteria
Participants in the case-control study:
i) Adults (18 years or older) admitted as rehabilitation inpatients, ii) diagnosis of stroke as per CT/MRI scan or medical report, iii) pharyngeal or oropharyngeal dysphagia diagnosed by a speech pathologist due to recent stroke (within 12 months), iv) medically stable v) adequate cognition (Functional Independence Measure = 12), vi) able and willing to give written or oral consent to participate and comply with increased dosage of swallowing intervention vii) no restriction on the languages spoken by the patient

Participants in the clinician focus group:
i) speech pathologist, allied health assistant or speech pathology volunteer at the rehabilitation hospital during the study ii) conducted swallowing intervention with participants iii) willing and able to give written consent to participate in focus group
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for participants in the case-control study:
i) Not referred for swallowing rehabilitation ii) have comorbidities which affect swallowing (e.g. neurodegenerative conditions, head and neck cancer) iii) females of reproductive age (i.e. 15-49 years as per World Health Organisation)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other
Other design features
Mixed-methods study involving: i) Quantatitive case-control study. Participants are allocated to a single prospective, experimental group. Their results will be compared with a historical control group sourced through medical record audit. ii) Qualitative semi-structured patient interviews and semi-structured clinician focus group.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The prospective experimental group will consist of 15-20 participants. The lack of precedents inhibits sample size calculation. Nonetheless, this sample size was selected in accordance with findings that a pilot study should involve at least 12 subjects to ensure considerable precision in mean and variance values, and to allow for potential drop outs.

The historical control group will consist of 41 participants. A minimum benchmark of 40 cases was used as per the National Stroke Foundation Clinical Audit on Rehabilitation Services.

After data collection is completed, participants in both groups will be compared to determine if matched-control analysis can be used. If not, data analysis will be conducted as a group-level comparison. Inferential statistics will be used to compare outcome measures between-groups. We will also conduct pre-post statistical analysis of outcomes within the prospective experimental group.

Qualitative data on participants’ and speech pathologists’ experiences and feelings about providing high-intensity therapy will be collated. The interviews and focus group will be audio-recorded and transcribed. Content analysis will be used to code and then group data into similar themes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17948 0
Braeside Hospital - Prairiewood
Recruitment postcode(s) [1] 31813 0
2176 - Prairiewood

Funding & Sponsors
Funding source category [1] 307125 0
University
Name [1] 307125 0
The University of Sydney
Address [1] 307125 0
Faculty of Medicine and Health, Sydney School of Health Sciences, The University of Sydney, Science Rd, Camperdown, Sydney NSW 2006, Australia
Country [1] 307125 0
Australia
Primary sponsor type
Hospital
Name
South Western Sydney Local Health District/Braeside Hospital
Address
340 Prairie Vale Rd, Prairiewood, NSW 2176
Country
Australia
Secondary sponsor category [1] 307829 0
University
Name [1] 307829 0
The University of Sydney
Address [1] 307829 0
Faculty of Medicine and Health, Sydney School of Health Sciences, The University of Sydney, Science Rd, Camperdown, Sydney NSW 2006, Australia
Country [1] 307829 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307237 0
South Western Sydney Local Health District Ethics Committee
Ethics committee address [1] 307237 0
Liverpool Hospital Eastern Campus, Scrivener Street, Liverpool NSW 2170
Ethics committee country [1] 307237 0
Australia
Date submitted for ethics approval [1] 307237 0
15/02/2021
Approval date [1] 307237 0
23/03/2021
Ethics approval number [1] 307237 0
2020/ETH02805

Summary
Brief summary
Up to two thirds of patients after stroke have swallowing problems. Patients with swallowing problems typically have worse health outcomes, reduced nutrition and hydration and poorer quality of life. Swallowing rehabilitation includes swallowing exercises which can improve swallowing ability. However, there is limited evidence about what dosage, or amount of swallowing intervention is most beneficial for patients.

This project will investigate the effect of increasing the dosage of swallowing intervention for patients with swallowing problems after stroke. The project will recruit 15-20 adults with swallowing difficulties after stroke from an inpatient rehabilitation hospital. Participants will receive daily swallowing intervention (five days per week) with a high dosage of swallowing exercise repetitions per session during their inpatient stay. Intervention will involve typically used rehabilitative swallowing exercises as identified by a medical record audit.

Change in oral intake, functional and instrumental swallowing assessments, muscle strength and quality of life outcome measures will be taken. Results will be compared before and after intervention. Results will also be compared with a historical control group of adults with post-stroke swallowing difficulties who received the same swallowing intervention at a lower dosage (i.e. mean of two-three days per week).

We will also investigate patient and staff experiences of high-dosage swallowing intervention and perceived barriers and facilitators to achieving high-dosage swallowing intervention through semi-structured interviews and a staff focus group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106514 0
Ms Jacinda Choy
Address 106514 0
Braeside Hospital
340 Prairie Vale Road
Prairiewood
NSW 2176
Country 106514 0
Australia
Phone 106514 0
+61 2 9756 8907
Fax 106514 0
Email 106514 0
jcho3318@uni.sydney.edu.au
Contact person for public queries
Name 106515 0
Ms Jacinda Choy
Address 106515 0
Braeside Hospital
340 Prairie Vale Road
Prairiewood
NSW 2176
Country 106515 0
Australia
Phone 106515 0
+61 2 9756 8907
Fax 106515 0
Email 106515 0
jcho3318@uni.sydney.edu.au
Contact person for scientific queries
Name 106516 0
Ms Jacinda Choy
Address 106516 0
Braeside Hospital
340 Prairie Vale Road
Prairiewood
NSW 2176
Country 106516 0
Australia
Phone 106516 0
+61 2 9756 8907
Fax 106516 0
Email 106516 0
jcho3318@uni.sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
In alignment with hospital and university rules, the complete data set will be available on request, but not individual participant data to ensure participant confidentiality.
What supporting documents are/will be available?
No other documents available
Summary results
No Results