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ssSIP site
ssSIP trial –
S
wallow
S
trength and
S
kill training with biofeedback
I
n
P
ost-stroke dysphagia
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
Printable CRFs
See also:
list of recent changes
.
(updated 114 days ago)
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
Please log in to download a zip archive of printable CRFs from the supporting site.
Participant contact details should be submitted directly online.
A printable preview of the contact details form is available
here
.
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