Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000759897p
Ethics application status
Submitted, not yet approved
Date submitted
19/04/2021
Date registered
16/06/2021
Date last updated
16/06/2021
Date data sharing statement initially provided
16/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Impairment-based rehabilitation of dysphagia post stroke
Scientific title
Effectiveness of rehabilitation targeting the underlying pathophysiological features: strength and skill training for dysphagia post stroke in adults
Secondary ID [1] 303703 0
none
Universal Trial Number (UTN)
U1111-1266-1761
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 321126 0
dysphagia 321127 0
swallowing impairment 321128 0
Condition category
Condition code
Oral and Gastrointestinal 318921 318921 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Stroke 318922 318922 0 0
Ischaemic
Stroke 318923 318923 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Impairment-based rehabilitation of dysphagia post stroke

Procedure:
* This study is an exploratory within subject, interventional A-B-A study design where, participants will be their own control.\
Participants will undergo 2 pre- and 2 post-treatment data collection sessions, all conducted 2 weeks apart. An initial 2-week ‘no-treatment’ period will enable the assessment of stability of measurement and task performance; a 2-week post-treatment period will enable the assessment of skill retention. When participants are available, an additional post-treatment data collection session will be carried out 2 months later in order to measure the longer-term retention of the effects.
* Intervention procedures will take place either at home or at an outpatient specialised University clinical research facility or at participants’ home. Participants will undergo a 2-week individual, face-to-face, intensive swallowing rehabilitation programme (1 hour session, 5 days per week, for a total amount of 10 sessions across 2 weeks, with attendance checklist to monitor adherence to the intervention). Participants will be allocated into two intervention groups at baseline, depending upon their dysphagia presentation, i.e presence of a strength or a precision (“skill”) deficit as identified using the method described by Ng et al. (2020). Participants with an identified strength impairment will undergo a strength-based training involving 100 effortful swallows across 1 hour; whereas participants identified with impairment of swallowing skill will undergo a skill-based training involving 100 skilled (timely and accurate) swallows across 1 hour.

Material:
Biofeedback for Strength and Skill Training™ (BiSSkiT™) software and treatment protocol, paired with NeuroTrac Simplex™ surface electromyography (sEMG) biofeedback device, with electrodes placed underneath the chin in order to capture the activity of the submental swallowing muscles. This will be used during the treatment sessions : participants will have to swallow and control their swallow (timing, amplitude) using biofeedback.

- Intervention and evaluation will be delivered by a fully qualified Speech-language Therapist (SLT) with over 15 years expertise in the treatment and rehabilitation of dysphagia. Randomisation and blinding of outcome measures will be used, with inter- and intra-rater reliability measured on 20% of the data sample.
Intervention code [1] 320010 0
Treatment: Devices
Intervention code [2] 320011 0
Treatment: Other
Intervention code [3] 320012 0
Rehabilitation
Comparator / control treatment
no control group, participants are their own control (A-B-A design)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326859 0
Functional intake using the Functional Oral Intake Scale (FOIS; Crary et al., 2012)
Timepoint [1] 326859 0
- At inclusion
- 2 weeks post inclusion (Baseline)
- 2 weeks post treatment (immediate treatment effects) - primary endpoint
- 4 weeks post treatment (short-term retention)
- 2,5 months post treatment (long term retention)
Primary outcome [2] 327136 0
Diet texture using the International Dysphagia Standardization Initiative Functional Diet Scale (IDDSI-FDS; Steele et al., 2018)
Timepoint [2] 327136 0
- At inclusion
- 2 weeks post inclusion (Baseline)
- 2 weeks post treatment (immediate treatment effects) - primary endpoint
- 4 weeks post treatment (short-term retention)
- 2,5 months post treatment (long term retention)
Primary outcome [3] 327137 0
Quality of life using the SWAL-QOL (McHorney et al., 2002)
Timepoint [3] 327137 0
Timepoints
- At inclusion
- 2 weeks post inclusion (Baseline)
- 2 weeks post treatment (immediate treatment effects) - primary endpoint
- 4 weeks post treatment (short-term retention)
- 2,5 months post treatment (long term retention)
Secondary outcome [1] 392899 0
Biomechanical measures carried out during VideoFluoroscopy Swallowing Study (VFSS):
--> hyolaryngeal displacement in %
Timepoint [1] 392899 0
- At inclusion
- 2 weeks post inclusion (Baseline)
- 2 weeks post treatment (immediate treatment effects)
- 4 weeks post treatment (short-term retention)
- 3 months post treatment (long term retention)
Secondary outcome [2] 392900 0
Biomechanical measures carried out during VFSS:
--> volume of pharyngeal residue in %
Timepoint [2] 392900 0
- At inclusion
- 2 weeks post inclusion (Baseline)
- 2 weeks post treatment (immediate treatment effects)
- 4 weeks post treatment (short-term retention)
- 3 months post treatment (long term retention)
Secondary outcome [3] 392901 0
Biomechanical measures carried out during VFSS:
--> timing measures of Swallow Reaction Time (SRT)
Timepoint [3] 392901 0
- At inclusion
- 2 weeks post inclusion (Baseline)
- 2 weeks post treatment (immediate treatment effects)
- 4 weeks post treatment (short-term retention)
- 3 months post treatment (long term retention)
Secondary outcome [4] 392902 0
Biomechanical measures carried out during VFSS:
--> timing measures of Total Pharyngeal Transit Time (PTT)
Timepoint [4] 392902 0
- At inclusion
- 2 weeks post inclusion (Baseline)
- 2 weeks post treatment (immediate treatment effects)
- 4 weeks post treatment (short-term retention)
- 3 months post treatment (long term retention)
Secondary outcome [5] 392903 0
Biomechanical measures carried out during VFSS:
--> timing measures of Laryngeal Vestibular Closure (LVC)
Timepoint [5] 392903 0
- At inclusion
- 2 weeks post inclusion (Baseline)
- 2 weeks post treatment (immediate treatment effects)
- 4 weeks post treatment (short-term retention)
- 3 months post treatment (long term retention)
Secondary outcome [6] 392904 0
Biomechanical measures carried out during VFSS:
--> timing measures of duration of upper oesophageal sphincter opening (UES)
Timepoint [6] 392904 0
- At inclusion
- 2 weeks post inclusion (Baseline)
- 2 weeks post treatment (immediate treatment effects)
- 4 weeks post treatment (short-term retention)
- 3 months post treatment (long term retention)
Secondary outcome [7] 392905 0
sEMG measures of PreMotor Time (PMT)
Timepoint [7] 392905 0
- At inclusion
- 2 weeks post inclusion (Baseline)
- 2 weeks post treatment (immediate treatment effects)
- 4 weeks post treatment (short-term retention)
- 3 months post treatment (long term retention)
Secondary outcome [8] 392906 0
sEMG measures of PreSwallow Time (PST)
Timepoint [8] 392906 0
- At inclusion
- 2 weeks post inclusion (Baseline)
- 2 weeks post treatment (immediate treatment effects)
- 4 weeks post treatment (short-term retention)
- 3 months post treatment (long term retention)
Secondary outcome [9] 392907 0
sEMG measures of Total Duration of muscle Contraction (TDC)
Timepoint [9] 392907 0
- At inclusion
- 2 weeks post inclusion (Baseline)
- 2 weeks post treatment (immediate treatment effects)
- 4 weeks post treatment (short-term retention)
- 3 months post treatment (long term retention)
Secondary outcome [10] 393940 0
Swallowing capacity for solids using the Test Of Masticating And Swallowing Solids (TOMASS; Huckabee et al., 2018)
Timepoint [10] 393940 0
- At inclusion
- 2 weeks post inclusion (Baseline)
- 2 weeks post treatment (immediate treatment effects)
- 4 weeks post treatment (short-term retention)
- 2,5 months post treatment (long term retention)
Secondary outcome [11] 393941 0
Penetration aspiration score during VFSS using the Penetration-Aspiration Scale (PAS; Rosenbek et al., 1996)
Timepoint [11] 393941 0
- At inclusion
- 2 weeks post inclusion (Baseline)
- 2 weeks post treatment (immediate treatment effects)
- 4 weeks post treatment (short-term retention)
- 2,5 months post treatment (long term retention)
Secondary outcome [12] 396027 0
Swallowing capacity for liquids using the Timed Water Swallowing Test (TWST; Hughes & Wiles, 1996)
Timepoint [12] 396027 0
- At inclusion
- 2 weeks post inclusion (Baseline)
- 2 weeks post treatment (immediate treatment effects)
- 4 weeks post treatment (short-term retention)
- 2,5 months post treatment (long term retention)

Eligibility
Key inclusion criteria
Participants must meet all of the inclusion criteria below to participate in this study:
- completion of the preliminary observational, prospective study (STUDY ONE) aiming at characterising dysphagia based on its underlying strength and skill deficits, with the presence of any pathological indicator from clinical exam AND presence of a strength or skill component underlying dysphagia as documented at completion of this first study
- able to participate in the treatment study (duration and location)
- able to provide informed written consent and to participate in an intensive rehabilitation programme.
Additionally, as this study involves applying an adhesive electrode patch under the chin, participants will be required to consent to shaving this area at each time point and during the treatment study.
An information sheet will be given to all eligible participants. Written informed consent for inclusion in the study and data collection will be obtained after full verbal explanation regarding the study aims and protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants meeting any of the exclusion criteria at baseline will not be included in the study:
- co-existing serious condition affecting swallowing and/or cognition (e.g. Head and neck cancer, Parkinson’s disease, Huntington’s disease, motor neuron disease, or major neurocognitive disorder)
- participants with current intubation or tracheostomy as it can affect swallowing
- unwillingness to provide written informed consent (participant, family / EPOA)
- any new stroke event occurring during the study period will result in termination of study involvement
- current involvement in rehabilitation of swallowing with another therapist

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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Characterising dysphagia based on its predominant strength vs. skill deficits is a novel concept and there are inadequate published data to calculate a required sample size for this exploratory, treatment pilot study. Therefore, formal sample size have not been calculated. As a result, all consecutive patients admitted and meeting the inclusion criteria (completion of STUDY ONE with remaining dysphagia characterised by strength of skill deficits) will be included within a period of 4 months from the start of the study, up to N=20. These data will consequently be used in further research as a basis for sample size calculation.

The clinical assessments (cranial nerve exam, TOMASS, TWST) will be video-recorded and these data, as well as the data from the VFSS and sEMG, will be analysed offline in a blinded and randomised fashion by the primary researcher.

After all participants have completed the research protocol, second ratings will be carried out on a random sample of 20% of the data set by the primary researcher (intrarater reliability) and by a second independent rater (interrater reliability), both blind to timepoint. Intra- and interrater reliability for each measure will be evaluated using Type 3 intra-class correlation coefficients (ICC 3,1) with standard error measurement. Clinical measures with an ICC = 0.75 will be accepted as having a good test-retest reliability (Koo & Li, 2016).

Descriptive statistics will be analysed and reported where appropriate. It is hypothesised that data will be analysed using mixed effects models, but this will be determined at the time of analysis. As multiple comparisons will be conducted, proper adjustment will be required. Overall evolution will be documented through data comparison between baselines (T0/T1), baseline and end of treatment (T1/T2), and after each follow-up session (T2/T3/T4).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/09/2021
Actual
Date of last participant enrolment
Anticipated
15/01/2022
Actual
Date of last data collection
Anticipated
15/06/2022
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 23539 0
New Zealand
State/province [1] 23539 0
Canterbury

Funding & Sponsors
Funding source category [1] 308118 0
University
Name [1] 308118 0
University of Canterbury Rose Centre for Stroke Recovery and Research
Country [1] 308118 0
New Zealand
Primary sponsor type
Individual
Name
Prof Maggie-Lee Huckabee
Address
UC Rose Centre for Stroke Recovery and Research
St George’s medical centre – Leinsters Chambers level one
248 Papanui Road
Merivale
Christchurch, 8014
Country
New Zealand
Secondary sponsor category [1] 308873 0
None
Name [1] 308873 0
Address [1] 308873 0
Country [1] 308873 0
Other collaborator category [1] 281727 0
Individual
Name [1] 281727 0
Dr Phoebe Macrae
Address [1] 281727 0
UC Rose Centre for Stroke Recovery and Research
St George’s medical centre – Leinsters Chambers level one
248 Papanui Road
Merivale
Christchurch, 8014
Country [1] 281727 0
New Zealand
Other collaborator category [2] 281728 0
Individual
Name [2] 281728 0
Dr Carl Hanger
Address [2] 281728 0
CDHB Burwood Hospital
300 Burwood Road,
Burwood,
Christchurch 8083
Country [2] 281728 0
New Zealand
Other collaborator category [3] 281729 0
Individual
Name [3] 281729 0
Dr Sarah Perry
Address [3] 281729 0
UC Rose Centre for Stroke Recovery and Research
St George’s medical centre – Leinsters Chambers level one
248 Papanui Road
Merivale
Christchurch, 8014
Country [3] 281729 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308104 0
New Zealand Health and Disability Ethics Committees
Ethics committee address [1] 308104 0
Ethics committee country [1] 308104 0
New Zealand
Date submitted for ethics approval [1] 308104 0
27/04/2021
Approval date [1] 308104 0
Ethics approval number [1] 308104 0

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

Contacts
Principal investigator
Name 109550 0
Mrs Marion Vallet
Address 109550 0
UC Rose Centre for Stroke Recovery and Research
St George’s medical centre – Leinsters Chambers level one
248 Papanui Road
Merivale
Christchurch, 8014
Country 109550 0
New Zealand
Phone 109550 0
+6433692385
Fax 109550 0
Email 109550 0
[email protected]
Contact person for public queries
Name 109551 0
Marion Vallet
Address 109551 0
UC Rose Centre for Stroke Recovery and Research
St George’s medical centre – Leinsters Chambers level one
248 Papanui Road - Merivale
Christchurch, 8014
Country 109551 0
New Zealand
Phone 109551 0
+6433692385
Fax 109551 0
Email 109551 0
[email protected]
Contact person for scientific queries
Name 109552 0
Maggie-Lee Huckabee
Address 109552 0
University of Canterbury Rose Centre for Stroke Recovery and Research
St George’s medical centre – Leinsters Chambers level one
248 Papanui Road - Merivale
Christchurch, 8014
Country 109552 0
New Zealand
Phone 109552 0
+6433695124
Fax 109552 0
Email 109552 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11361Study protocolAvailable on request only on completion of the study [email protected]
11362Statistical analysis planAvailable on request only on completion of the study [email protected]
11363Clinical study reportAvailable on request only on completion of the study [email protected]
11364Ethical approvalAvailable on request only on completion of the study [email protected]
11365Analytic codeAvailable on request only on completion of the study [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.