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Trial registered on ANZCTR


Registration number
ACTRN12619000414112
Ethics application status
Approved
Date submitted
8/03/2019
Date registered
13/03/2019
Date last updated
13/03/2019
Date data sharing statement initially provided
13/03/2019
Date results information initially provided
13/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of electrical stimulation treatment on adults with MS with swallowing problems
Scientific title
Effects of Neuromuscular Electrostimulation in the Treatment of Dysphagia in Adults with Multiple Sclerosis: A Randomized Controlled Trial
Secondary ID [1] 297675 0
MS Research Australia 17-0325
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Swallowing problems 311953 0
Multiple Sclerosis 312005 0
Condition category
Condition code
Neurological 310530 310530 0 0
Multiple sclerosis
Oral and Gastrointestinal 310569 310569 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
Neuromuscular electrical stimulation (NMES). There are two arms in this study:
1) Treatment group receiving active stimulation
2) Control group receiving sham stimulation

Treatment group:
- Received active NMES (11.5 mA; range 9–16.5 mA)) + swallowing exercise
- Swallowed every 20 seconds, for a total of 60 swallows per session
- Were stimulated for 20 minutes per session, for a total of two sessions per week, for three consecutive weeks.

The treatment study took place at the Communication Disorders Treatment and Research Clinic (CDTRC) at The University of Sydney. A speech pathologist (SLP) with 10 years’ experience contacted the participants in the treatment group and set a schedule for their treatment sessions. The SLP sent reminder text messages to the participants 2 days before the session.

During the NMES treatment the SLP positioned two electrodes below the participant’s chin, specifically between the tip of the chin and the hyoid bone, in order to stimulate the floor of the mouth muscles. After placing the electrodes, the SLP set the stimulation. Participants in the treatment group were stimulated set just below the highest tolerable intensity to ensure muscle contraction, whereas in the control group participants were stimulated at a sensory level only, which did not elicit contraction of the targeted muscles.
Participants in the treatment group, were instructed to swallow as hard as they could every time they felt the electric current, and to rest in between the cycles of stimulation. Participants in the control group were instructed to swallow as hard as they could every time they heard a beep sound from the NMES device, and to rest in between the cycles of stimulation. Thus, all participants had to swallow every 20 seconds, for a total of 60 swallows per session. Each participant was stimulated for 20 minutes per session, for a total of two sessions per week, for three consecutive weeks.

Intervention code [1] 313907 0
Treatment: Devices
Intervention code [2] 313908 0
Rehabilitation
Comparator / control treatment
Control group:
- Received sham NMES (mean stimulation intensity was 2.75 mA; range 1.5–4 mA) + swallowing exercise
- Swallowed every 20 seconds, for a total of 60 swallows per session
- Were given sham stimulation for 20 minutes per session, for a total of two sessions per week, for three consecutive weeks.
Control group
Active

Outcomes
Primary outcome [1] 319389 0
Change in the water/yoghurt residue as determined by the bolus residue scale (BRS)
Timepoint [1] 319389 0
Baseline and 2 weeks post-treatment completion
Primary outcome [2] 319390 0
Change in the signs of penetration/aspiration into the airway as determined by the penetration/aspiration scale (PAS), etc.
Timepoint [2] 319390 0
Baseline and 2 weeks post-treatment completion
Primary outcome [3] 319391 0
No. restrictions for any oral intake in the functional oral intake scale (FOIS)
Timepoint [3] 319391 0
Baseline and 2 weeks post-treatment completion
Secondary outcome [1] 368001 0
Change in quality of life in the swallowing/eating domain as determined by the Swallowing Quality of Life questionnaire (SWALQOL).
Timepoint [1] 368001 0
Baseline and 2 weeks post-treatment completion

Eligibility
Key inclusion criteria
Initial eligibility criteria for participants were adults above the age of 18 years, with a confirmed diagnosis of MS and a self/family report of swallowing difficulties. Further eligibility criteria were based on the presence of swallowing difficulties as shown in the FEES during the first session.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria were a history of dysphagia that was unrelated to MS, previous treatment with electrical stimulation, or if they did not meet any of the inclusion criteria..

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)
Allocation was concealed through central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple radomisation using a 1:1 randomized block design to achieve a balanced group size. The randomization list was created using a standard website for generating randomization lists (https://www.sealedenvelope.com/simple-randomiser/v1/lists).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Explanatory parallel-group randomized controlled trial to test whether active NMES (treatment group) is superior to sham NMES plus exercise (control group).
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Based on a sample size calculation using power analysis and sample size (PASS) software (power of .8, alpha .05), two groups of 13 participants were needed to detect a statistically significant difference between the treatment group and the control group, leading to the inclusion of 26 participants. Collected data were analysed using the Statistical Package for the Social Sciences 22 (SPSS, IBM). Mann-Whitney test was used for ordinal variables to compare differences in demographics between the two groups at baseline. Fisher Exact test was used for categorical variables to compare differences in demographics between the two groups at baseline. To evaluate treatment effects in the primary outcome measures, the Wilcoxon Signed Ranks Test was used to compare the differential effect of NMES on the participants’ swallowing function. Cohen’s effect size was used to measure the size of effect between the two groups using effect size calculator (https://www.uccs.edu/lbecker/). All statistical tests were two-tailed and evaluated with a 5%-level of significance. The power for this study was set at 0.80.

Recruitment
Recruitment status
Completed
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] 13344 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 25943 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 302203 0
Charities/Societies/Foundations
Name [1] 302203 0
MS Research Australia
Address [1] 302203 0
Level 19, 100 Miller Street, North Sydney
Country [1] 302203 0
Australia
Primary sponsor type
Individual
Name
Hans Bogaardt
Address
The University of Sydney
FHS / S169, 75 East Street, Lidcombe, NSW 2141
Country
Australia
Secondary sponsor category [1] 302046 0
Individual
Name [1] 302046 0
Kirrie Ballard
Address [1] 302046 0
The University of Sydney
FHS, 75 East Street, Lidcombe, NSW 2141
Country [1] 302046 0
Australia
Secondary sponsor category [2] 302048 0
Individual
Name [2] 302048 0
Dalal Alali
Address [2] 302048 0
Univeristy of Sydney FHS/S169
75 East street, Lidcombe, NSW 2141
Country [2] 302048 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302882 0
the University of Sydney Human Research Ethics Committee (HREC)
Ethics committee address [1] 302882 0
The University of Sydney, Camperdown NSW 2006
Ethics committee country [1] 302882 0
Australia
Date submitted for ethics approval [1] 302882 0
28/03/2016
Approval date [1] 302882 0
13/05/2016
Ethics approval number [1] 302882 0
2016/343

Summary
Brief summary
This study will evaluate the effectiveness of electrical stimulation in improving swallowing function and quality of life among adults with MS with swallowing problems. Research around electrical stimulation suggests that there is considerable potential for participants of this project to improve their functional swallowing abilities and hence improving quality of life and emotional wellbeing.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91722 0
Mrs Dalal Alali
Address 91722 0
University of Sydney
FHS / S164, 75 East Street, Lidcombe, NSW 2141
Country 91722 0
Australia
Phone 91722 0
+61 0423864828
Fax 91722 0
Email 91722 0
dala4451@uni.sydney.edu.au
Contact person for public queries
Name 91723 0
Mrs Dalal Alali
Address 91723 0
University of Sydney
FHS / S164, 75 East Street, Lidcombe, NSW 2141
Country 91723 0
Australia
Phone 91723 0
+61 0423864828
Fax 91723 0
Email 91723 0
dala4451@uni.sydney.edu.au
Contact person for scientific queries
Name 91724 0
Mrs Dalal Alali
Address 91724 0
University of Sydney
FHS / S164, 75 East Street, Lidcombe, NSW 2141
Country 91724 0
Australia
Phone 91724 0
+61 0423864828
Fax 91724 0
Email 91724 0
dala4451@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
Only group data will be publicly available and not individuals' data.
What supporting documents are/will be available?
Statistical analysis plan
Ethical approval
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – plain English summary
1. Research question
Is neuromuscular electrical stimulation (NMES) effective in treating swallowing problems in adults with Multiple Sclerosis (MS)?

2. Background information
There are limited treatment options for swallowing problems for adults with MS. In previous studies, NMES showed positive effects in treating swallowing problems in adults with MS, however these studies had limitations.

3. Participant characteristics
Twelve adults with mild MS were randomly assigned to a treatment group, who received active stimulation and exercise (n=6) or control group, who received sham stimulation and exercise (n=6). Randomisation and allocation to trial group were carried out by a computer system. Both groups were treated twice per week for three weeks. At baseline and two weeks post treatment, their swallowing function was assessed using fiberoptic endoscopic evaluation of swallowing (FEES) ted to evaluate the effectiveness of the treatment using outcome measures including bolus residue scale (BRS), penetration/aspiration scale (PAS), functional oral intake scale (FOIS) and swallowing quality of life questionnaire (SWALQOL).

4. Key results
The study suggests a potential benefit of NMES in reducing residue of thick fluids in adults with mild MS with swallowing problems. It was also beneficial in improving their quality of life. No adverse effects were reported during or after the treatment.

5. Limitations
The greatest limitation of this study was the low number of participant