ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617001269325

Ethics application status

Approved

Date submitted

10/08/2017

Date registered

1/09/2017

Date last updated

10/12/2020

Date data sharing statement initially provided

16/07/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Swallowing skill training in neurodegenerative disease.

Scientific title

Skill based dysphagia therapy as an intervention for individuals with Amyotrophic Lateral
Sclerosis or Huntington’s Disease.

Secondary ID [1]

Nil known.

Universal Trial Number (UTN)

U1111-1200-3369

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Amyotrophic Lateral Sclerosis

Motor Neurone Disease

Huntington's Disease

Dysphagia

Condition category

Condition code

Neurological

Neurodegenerative diseases

Physical Medicine / Rehabilitation

Speech therapy

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Rehabilitative intervention will be delivered face-to-face by University of Canterbury research personnel who also hold professional qualifications in Speech and Language Therapy. Intervention will comprise of 5 x 1 hour sessions per week for two weeks at the University of Canterbury Rose Centre for Stroke Recovery and Research.

Treatment will use surface electromyography (sEMG) hardware and the custom designed Biofeedback in Strength and Skill Training (BiSSkiT) software (Huckabee, Sella, Jones & Han). The software is designed to incorporate skill training approaches with the aim to improve patients’ conscious control and precision over swallowing. Participants will be seated facing the computer screen. sEMG electrodes on a small self-adhesive patch, will be adhered under the participant’s chin over the submental muscles (geniohyoid, mylohyoid and anterior bellies of the digastric). The patch and electrodes will also be secured with medical tape to minimise interference from involuntary limb movements. The sEMG electrodes will be attached to a Verity Medical Myotrac Simplex Plus device, which then sends the sEMG signal either via Bluetooth to the computer and displays the sEMG data through the BiSSkiT software. Activity of the submental muscles will be displayed as a time by amplitude waveform. The parameters of the participant’s swallow are set in the first session using a calibration sequence where the participant completes five effortful swallows over 150 seconds. BiSSkit software utilises the amplitude of the calibration trials to provide a ‘target’ box randomly placed on the screen, between 30 and 70% of the participants’ average maximal amplitude during effortful swallowing. Each 30 second trial requires the participant to dry swallow such that the peak of the waveform falls within the centre of the target box. There are 10 trials per block, and eight blocks per session, separated by a 90 second rest periods. The accuracy and precision of the skill is targeted as the participant is required to consciously modify the timing and amplitude of their swallowing during each trial, based on feedback from a previous trial. They receive immediate auditory and visual feedback to inform them of the success of their performance. The task is made more difficult as the participant’s accuracy improves as the target box decreases by 10% following three consecutive successful ‘hits’. The box also increases in size by 10% following three consecutive ‘misses’ to reduce task difficulty.

BiSSkiT software provides data on each trial, and a summary of 'hit' accuracy per one hour session. The researchers will monitor task adherence during the session, and examine summary data to ensure participants are completing the protocol as designed. For example, ensuring each peaked waveform corresponds to a full swallow.

Intervention code [1]

Rehabilitation

Intervention code [2]

Treatment: Devices

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Oropharyngeal functional swallowing of solids (number of bites, masticatory cycles, swallows and total time): measured by the Test of Masticating and Swallowing Solids.

Timepoint [1]

Measures collected at 4 time points:
Baseline (2 weeks no-treatment phase), pre-treatment, post-treatment (2 week treatment retention phase), final measure (2 weeks post completion of treatment).

Primary outcome [2]

Patient reported quality of life (dysphagia symptom specific): measured by Swallowing Quality of Life Questionnaire.

Timepoint [2]