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Does increasing the amount of swallowing therapy improve outcomes for adults with swallowing problems after stroke?

The effect of increasing the dosage of swallowing intervention on oral intake in adult inpatients with post-stroke dysphagia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000465853
Enrollment
3
Registered
2021-04-20
Start date
2021-05-19
Completion date
2022-10-05
Last updated
2022-04-25

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

Conditions

None listed

Brief summary

Up to two thirds of patients after stroke have swallowing problems. Patients with swallowing problems typically have worse health outcomes, reduced nutrition and hydration and poorer quality of life. Swallowing rehabilitation includes swallowing exercises which can improve swallowing ability. However, there is limited evidence about what dosage, or amount of swallowing intervention is most beneficial for patients. This project will investigate the effect of increasing the dosage of swallowing intervention for patients with swallowing problems after stroke. The project will recruit 15-20 adults with swallowing difficulties after stroke from an inpatient rehabilitation hospital. Participants will receive daily swallowing intervention (five days per week) with a high dosage of swallowing exercise repetitions per session during their inpatient stay. Intervention will involve typically used rehabilitative swallowing exercises as identified by a medical record audit. Change in oral intake, functional and instrumental swallowing assessments, muscle strength and quality of life outcome measures will be taken. Results will be compared before and after intervention. Results will also be compared with a historical control group of adults with post-stroke swallowing difficulties who received the same swallowing intervention at a lower dosage (i.e. mean of two-three days per week). We will also investigate patient experiences of high-dosage swallowing intervention and perceived barriers and facilitators to achieving high-dosage swallowing intervention through semi-structured interviews.

Interventions

Based on impairments identified during assessment, participants will be prescribed individualised swallowing exercises by their treating speech pathologist. Exercises will target coordination and range-of-movement of oral muscles, strengthening of pharyngeal muscles and swallow-specific exercises. Exercises may include Shaker head lift, chin tuck against resistance, lip and tongue exercises and Mendelsohn maneuver. The target number of repetitions of each exercise per session will be double the

Based on impairments identified during assessment, participants will be prescribed individualised swallowing exercises by their treating speech pathologist. Exercises will target coordination and range-of-movement of oral muscles, strengthening of pharyngeal muscles and swallow-specific exercises. Exercises may include Shaker head lift, chin tuck against resistance, lip and tongue exercises and Mendelsohn maneuver. The target number of repetitions of each exercise per session will be double the mean number of repetitions of each exercise per session (± 1 standard deviation) in the control group (identified from medical record audit). Participants in the experimental group will receive daily rehabilitative swallowing intervention (i.e. five days per week). Participants will be seen by their usual treating speech pathologist for individual face-to-face sessions in an inpatient rehabilitation hospital. They will also receive additional face-to-face individual swallowing intervention sessions provided by either trained speech pathologists, supervised students or research assistants/volunteers, so that they are seen five days per week in total. The additional swallowing intervention sessions will consist of the same exercises and target dosages as sessions with their treating speech pathologist. Intervention will be ceased when participants return to their premorbid diet and fluids; or if they are discharged from the inpatient rehabilitation ward (whichever comes first). Data on exercises, dosage and adherence will be collected (i.e. type of exercises, number and length of sessions, and number of exercise repetitions). If participants are unable to complete the target number of sessions or repetitions, reasons why will be documented. The exercises and dosages prescribed in therapy sessions will be provided as a home exercise program to participants and their caregivers, along with an exercise record and a hand-held tally counter. Participants or family members will be asked to count and record all repetitions practised outside of therapy sessions.

Sponsors

South Western Sydney Local Health District/Braeside Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)

Eligibility

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

Inclusion criteria

Participants in the case-control study: i) Adults (18 years or older) admitted as rehabilitation inpatients with an expected admission of at least five days, ii) diagnosis of stroke as per CT/MRI scan or medical report, iii) oropharyngeal dysphagia diagnosed by a speech pathologist due to recent stroke (within 12 months), iv) medically stable v) adequate cognition (Cognitive Functional Independence Measure >9), vi) able and willing to give written or oral consent to participate and comply with increased dosage of swallowing intervention vii) no restriction on the languages spoken by the patient.

Exclusion criteria

Exclusion criteria for participants in the case-control study: i) Not referred for swallowing rehabilitation ii) have comorbidities which affect swallowing (e.g. neurodegenerative conditions, head and neck cancer) iii) pregnant women.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026