Impairment-based rehabilitation of dysphagia post stroke

Not Applicable

Not yet recruiting

• Conditions: stroke; dysphagia; swallowing impairment; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Stroke - Ischaemic; Stroke - Haemorrhagic

• Registration Number: ACTRN12621000759897
• Lead Sponsor: Prof Maggie-Lee Huckabee

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-16
• Last Update Posted: 21 June 2021

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 20

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional intake using the Functional Oral Intake Scale (FOIS; Crary et al., 2012)[- At inclusion<br>- 2 weeks post inclusion (Baseline)<br>- 2 weeks post treatment (immediate treatment effects) - primary endpoint<br>- 4 weeks post treatment (short-term retention)<br>- 2,5 months post treatment (long term retention)];Diet texture using the International Dysphagia Standardization Initiative Functional Diet Scale (IDDSI-FDS; Steele et al., 2018)[- At inclusion<br>- 2 weeks post inclusion (Baseline)<br>- 2 weeks post treatment (immediate treatment effects) - primary endpoint<br>- 4 weeks post treatment (short-term retention)<br>- 2,5 months post treatment (long term retention)];Quality of life using the SWAL-QOL (McHorney et al., 2002)[Timepoints<br>- At inclusion<br>- 2 weeks post inclusion (Baseline)<br>- 2 weeks post treatment (immediate treatment effects) - primary endpoint<br>- 4 weeks post treatment (short-term retention)<br>- 2,5 months post treatment (long term retention)]