Trial documents

Approved protocol

• PROTOCOL 20221103 Final Version 1.0.pdf
• PROTOCOL 20230711 Final version 2.0.pdf
• PROTOCOL 20240102 Final version 3.0.pdf

Site training

• SIV Slides 20230417 V1.0.pdf
• SIV Slides 20230901 V2.0.pdf

Information sheets and consent forms

• Advice Form Consultee NO VFS 20230302 Final Version 2.1.doc
• Advice Form Consultee WITH VFS 20230302 Final Version 2.1.doc
• Aphasia friendly PIS NO VFS 20230302 Version 2.1.docx
• Aphasia friendly PIS WITH VFS 20230302 Version 2.1.docx
• Clinician Interview PIS 20230228 Final Version 1.1.docx
• Clinician Observation PIS 20230302 Final Version 1.1.docx
• Consent Form WITH VFS 20230302 Final Version 1.1.docx
• Consent form NO VFS 20230302 Final Version 1.1.docx
• Consultee Information form NO VFS 20030228 Final Version 2.docx
• Consultee Information form WITH VFS 20030228 Final Version 2.docx
• Participant Information Sheet NO VFS 20030227 Final Version 1.1.docx
• Participant Information Sheet WITH VFS 20030228 Final Version 1.1.docx
• SLT Interview Consent form 20230302 Version 1.1.docx
• SLT Observation Consent form 20230302 Version 1.1.docx

REC documents

• 23LO0131 IRAS 319969 Favourable Opinion of 22043 SA01 20230818.pdf
• 319969 REC Favourable opinion on further information 20230309.pdf

MHRA documents

• 319969 Letter of HRA Approval 20230310 amended.pdf

• Screening and eligibility v1.3
• Screening assessment v1.0
• Measured outcome v1.1
• Strength skill assessment v1.0
• Videofluoroscopy v1.2
• Therapy session v1.0
• Day 15 follow-up v1.0
• Day 90 follow-up v1.0
• Dysphagia handicap index at day 90 v1.1
• Resource use at day 90 v1.1
• Discharge or death in hospital v1.1
• Protocol violation v1.0
• Withdrawal notification v1.1
• Serious Adverse Event v1.0
• Data correction request v1.0