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Swallowing skill training in neurodegenerative disease.

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001269325
Enrollment
38
Registered
2017-09-01
Start date
2018-02-01
Completion date
2020-02-26
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Aim: To evaluate the effectiveness of skill training on functional swallowing and quality of life in patients with Amyotrophic Lateral Sclerosis (ALS) or Huntington’s Disease (HD). Procedure: Participants will attend four assessment and ten treatment sessions over a six week period. Treatment will consist of ten sessions over two weeks. This is both preceded and followed by a no treatment block to evaluate the treatment and maintenance effects. Rehabilitation sessions will consist of skill training via the Biofeedback in Strength and Skill Training (BiSSkiT) protocol. This utilises surface electromyography (sEMG) as a form of biofeedback while swallowing. SEMG will measure the activity of swallowing muscles with electrodes which are placed under the chin on the skin's surface. SEMG waveforms are displayed on a computer monitor allowing participants to visualise and cortically control their muscle activity while swallowing. A challenge task is included in the software, encouraging cortical control of swallowing. A target box will randomly appear on the screen and participants will attempt swallow such that the peak of the swallow waveform lands within the target box. Outcome measures include both clinical and instrumental measures of swallowing as well as self reported quality of life.

Interventions

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, Jone

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.

Sponsors

University of Canterbury Rose Centre for Stroke Recovery and Research
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Diagnosis of Probable or definite Amyotrophic Lateral Sclerosis as measured by the El Escorial Criteria with a minimum ALSFRS-R bulbar subscale score of 9 OR Diagnosis of HD through clinical symptoms confirmed by a neurologist and the presence of greater than or equal to 36 CAG repeats on genetic testing

Exclusion criteria

Patients will not be eligible if they: Score less than 26 on the Montreal Cognitive Assessment Have a co-occurring condition that may effect swallowing Score less than 3 on the Eating Assessment Tool 10 Are unable to eat solid textures or drink thin liquids

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 8, 2026