Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000416897
Ethics application status
Approved
Date submitted
11/02/2021
Date registered
15/04/2021
Date last updated
16/02/2024
Date data sharing statement initially provided
15/04/2021
Date results information initially provided
26/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of a computer-based training program on swallowing-related quality of life, swallowing function and the power and precision of swallowing for adults with chronic dysphagia.
Scientific title
Investigating the effect of skill-based swallowing therapy using the Biofeedback in Strength and Skill Traning (BiSSkiT) program on swallowing-related quality of life, swallowing function and the power and precision of swallowing for adults with chronic dysphagia.
Secondary ID [1] 303422 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic dysphagia 320718 0
Condition category
Condition code
Diet and Nutrition 318562 318562 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 319300 319300 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
A relatively new computer-based training program, called Biofeedback in Strength and Skill Training (BiSSkiT), was developed by Professor Maggie-Lee Huckabee at the Rose Centre for Stroke Recovery and Research, University of Canterbury, Christchurch, New Zealand. BiSSkiT comprises a training protocol and accompanying software program, with surface electromyography as the underlying hardware, for the rehabilitation and outcome measurement of swallowing impairments. The BiSSkiT software will be loaded onto a computer and the BiSSkiT intervention provided face-to-face on a one-to-one basis by one of main investigators. The BiSSkiT intervention involves application of surface electrodes under the chin, allowing measurement of the activity of the floor-of-mouth muscles (mylohyoid, geniohyoid, genioglossus and anterior belly of diagastric) that are involved in anterior hyoid excursion (the movement of the hyoid bone by the muscles during the pharyngeal phase of a swallow). The activity arising from the floor-of-mouth muscles is fed into a computer program that generates real-time amplitude waveform images on the computer screen and provides visual and auditory feedback. The program is aimed at increasing both strength and the precision of muscle contraction, thus providing the necessities of motor learning to drive neural change (e.g. high intensity and high repetition; clear visual waveform display to monitor and adapt task performance; feedback that is adapted to patient performance to increase task challenge; a variety of audio and visual feedback to maintain interest and motivation). For example, to increase strength the display highlights the maximal contraction achieved and provides visual and auditory feedback to achieve this on repeated occasions and, over time, increase the strength of the contraction. To improve the precision of muscle contraction, the program prompts the user to generate a pre-determined sub-maximal contraction at a set time. The BiSSkiT program uses images, such as a bee (whose movement across the computer screen is the trace of the muscle contraction) buzzing into a flower (which is the desired maximal or sub-maximal contraction). The difficulty of BiSSkiT tasks is increased or decreased depending on each persons’ response and individually tailored to meet his/her training requirements. The interventions are each of one hour’s duration, provided three times a week, for a total of 10 interventions. Thus, the intervention period will last 4 weeks. A log book will be kept to document adherence with session attendance.
Intervention code [1] 319727 0
Rehabilitation
Intervention code [2] 319985 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326518 0
Swallowing-related quality of life which will be measured using the SWAL-QOL survey. This is a 44 items self-administered questionnaire.
Timepoint [1] 326518 0
Baseline (twice, one week apart), at conclusion of the intervention period (approximately one month) and one month post-intervention.
Secondary outcome [1] 391750 0
Swallowing function which will be measured using the Eating Assessment Tool (EAT-10). This is a self-administered survey comprising 10 items.
Timepoint [1] 391750 0
Baseline (twice, one week apart), at conclusion of the intervention period (approximately one month) and one month post-intervention.

Eligibility
Key inclusion criteria
Patients (at least 18 years old) currently attending an outpatient clinic within the Central Adelaide Local Health Network with a history of chronic dysphagia (i.e. > 6 months duration) of a severity that requires dietary modification and/or other strategies .
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Refused consent. Neck anatomy (e.g. local scarring, skin problems) preventing the ability to apply and use the surface electrodes. Visual or auditory deficit which would preclude the ability to see/hear BiSSkiT feedback. Cognitive deficit that would preclude the ability to participate in the BiSSkiT program. Inability to understand sufficient written/spoken English to be able to participate in the BiSSkiT program and complete the outcome measurements. Unwilling to commit to attendance for the BiSSkiT interventions and assessments. Currently receiving or about to receive any other interventions specifically aimed at dysphagia (excluding dietary modification).

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)
Not applicable.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 10-20 participants will be sought. This relatively small sample size is believed to be sufficient to evaluate the effect of the BiSSkiT program given: the introductory nature of this study. Data will be imported into SPSS for basic descriptive analyses. Changes in the outcomes over time will be analysed, with the help of a statistician, using paired samples t tests and/or general linear model repeated measures analysis of variance tests.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/05/2021
Actual
20/04/2021
Date of last participant enrolment
Anticipated
Actual
11/10/2021
Date of last data collection
Anticipated
Actual
11/11/2021
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 18695 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [2] 18696 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 18697 0
Hampstead Rehabilitation Centre - Northfield
Recruitment postcode(s) [1] 33133 0
5011 - Woodville
Recruitment postcode(s) [2] 33134 0
5000 - Adelaide
Recruitment postcode(s) [3] 33135 0
5085 - Northfield

Funding & Sponsors
Funding source category [1] 307840 0
Other Collaborative groups
Name [1] 307840 0
The Hospital Research Foundation and University of South Australia Allied Health Collaborative Group
Country [1] 307840 0
Australia
Primary sponsor type
Individual
Name
Kathy Stiller
Address
7F-060 Royal Adelaide Hospital
Port Road
Adelaide, South Australia 5000
Country
Australia
Secondary sponsor category [1] 308548 0
Individual
Name [1] 308548 0
Dianna Burchell
Address [1] 308548 0
Queen Elizabeth Hospital DRS
28 Woodville Rd
Woodville, South Australia 5011
Country [1] 308548 0
Australia
Secondary sponsor category [2] 308549 0
Individual
Name [2] 308549 0
Samantha Hosking
Address [2] 308549 0
Queen Elizabeth Hospital DRS
28 Woodville Rd
Woodville, South Australia 5011
Country [2] 308549 0
Australia
Secondary sponsor category [3] 308550 0
Individual
Name [3] 308550 0
Maria Kambanaros
Address [3] 308550 0
University of South Australia
Level 4 Playford Building, GPO Box 2471
City East Campus, Adelaide
South Australia 5001
Country [3] 308550 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307839 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 307839 0
CALHN Human Research Ethics Committee
Level 3, Roma Mitchell House
136 North Terrace
Adelaide
South Australia 5000
Ethics committee country [1] 307839 0
Australia
Date submitted for ethics approval [1] 307839 0
01/02/2021
Approval date [1] 307839 0
09/04/2021
Ethics approval number [1] 307839 0
14382

Summary
Brief summary
Dysphagia is the term used to describe difficulty with swallowing. It is common condition and increases the risk of choking, pneumonia, malnutrition and dehydration which, in turn, can result in hospitalisation or even death. Dysphagia can have a major adverse impact on quality of life. A relatively new computer-based training program, called Biofeedback in Strength and Skill Training (BiSSkiT), was developed in New Zealand. BiSSkiT comprises a training protocol and accompanying software program, with surface electrodes as the underlying hardware, for the rehabilitation and outcome measurement of swallowing impairments. The effectiveness of the BiSSkiT program in clinical settings apart from Parkinson’s Disease has not been investigated to date.
The overall purpose of this preliminary study is to evaluate whether the BiSSkiT computer-based program improves the swallowing ability of patients with chronic dysphagia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108690 0
Ms Dianna Burchell
Address 108690 0
Queen Elizabeth Hospital DRS
28 Woodville Rd
Woodville South
Adelaide
South Australia 5011
Country 108690 0
Australia
Phone 108690 0
+61 8 82228169
Fax 108690 0
Email 108690 0
[email protected]
Contact person for public queries
Name 108691 0
Ms Dianna Burchell
Address 108691 0
Queen Elizabeth Hospital DRS
28 Woodville Rd
Woodville South
Adelaide
South Australia 5011
Country 108691 0
Australia
Phone 108691 0
+61 8 82228169
Fax 108691 0
Email 108691 0
[email protected]
Contact person for scientific queries
Name 108692 0
Dr Kathy Stiller
Address 108692 0
7F-060 Royal Adelaide Hospital
Port Road
Adelaide
South Australia 5000
Country 108692 0
Australia
Phone 108692 0
+61 8 70742639
Fax 108692 0
Email 108692 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Burchell D, Hosking S, Kambanaros M, Stiller K. Sk... [More Details]

Documents added automatically
No additional documents have been identified.