Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001339145
Ethics application status
Approved
Date submitted
5/09/2019
Date registered
30/09/2019
Date last updated
30/09/2019
Date data sharing statement initially provided
30/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Repetitive speech in aphasia after stroke and the effect of speech therapy
Scientific title
The Influence of Phonological Cueing on Reducing Recurrent Perseveration in Individuals with Post-stroke Aphasia: A Case Series.
Secondary ID [1] 299160 0
Nil known.
Universal Trial Number (UTN)
U1111-1239-6685
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Perseveration in post-stroke aphasia 314234 0
Condition category
Condition code
Physical Medicine / Rehabilitation 312596 312596 0 0
Speech therapy
Stroke 312759 312759 0 0
Haemorrhagic
Stroke 312760 312760 0 0
Ischaemic
Neurological 312761 312761 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study primarily consists of language assessments which are observational. The final element of the study is a one-hour facilitation session. All sessions will be completed by the coordinating researcher (a qualified speech therapist). It is anticipated that there will be a total participation time of 4-6 hours. This time will be split across sessions and no session will be more than 1 hour in duration. All sessions for a given participant will be completed within a two week period (e.g. ~2-3 sessions per week for two weeks/~a session every 2-3 days). All sessions are one-to-one between each participant and the coordinating researcher.

The observational language sessions will involve participants completing the following language assessments:
1. PALPA Subtest 2 and 8 (session 2)
2. Comprehensive Aphasia Test (split across session 2 and 3)
3. Apraxia of Speech Rating Scale (session 1)
4. Pyramids and Palm Trees Test (session 3)
5. Philadelphia Naming Test (session 1 and repeated in session 4)

Following these sessions, a final, facilitation session will be carried out in which the participants will complete the Philadelphia Naming Test again. During this administration, the coordinating researcher will provide phonological cueing (i.e. provide the participant with the initial sounds of the picture name to assist their naming) to half the test items. This is the cued condition. The participants will be asked to name the remaining test items without a cue (unfacilitated condition). All items in both cued and unfacilitated conditions will be presented within the same session and items will be pseudorandomised. This session will help to determine if phonological cueing reduces the number of perseverative errors participants make during confrontational naming (naming pictures).

Intervention fidelity will not be assessed directly however the facilitation sessions will be video recorded and an independent rater will carry out inter-rater reliability on 20% of the data. In addition, the picture naming test used in the facilitation session is electronic and this will help ensure that each picture is automatically presented at the same presentation rate across participants and that the phonological cues (audio recordings) present to participants are identical.
Intervention code [1] 315447 0
Rehabilitation
Comparator / control treatment
There is no control group. However all participants will complete picture naming under both a cued condition (where a phonological cue is provided) as well as an unfacilitated condition (where no cue is provided).
Control group
Active

Outcomes
Primary outcome [1] 321246 0
Number of perseverative errors during a picture naming task.
Timepoint [1] 321246 0
At baseline one and two (consecutive sessions) and again at facilitation session (final session- within two-weeks of baseline testing).
Secondary outcome [1] 374446 0
Number of non-perseverative errors during picture naming task, when cueing is provided.
Timepoint [1] 374446 0
At facilitation session (final session- within two-weeks of baseline testing). I.e. the number of perseverative errors made when cueing is provided in the facilitation session will be compared to the number of perseverative errors made without cueing during baseline sessions.

Eligibility
Key inclusion criteria
To be eligible participants must:
1. Have had a stroke
2. Have a diagnosed post-stroke aphasia
3. Perseverate on at least 20% of items during administration of the Philadelphia Naming Test.
4. Have sufficient English proficiency to complete the language assessments
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The following are exclusion criteria for this study:
1. Formal diagnosis of dementia
2. Profound apraxia of speech
3. Unable to give informed consent
4. Comorbid learning, neurological or psychiatric disabilities/disorders
5. Have significant uncorrected vision or hearing impairment
6. Significant fatigue that is limiting their participation in daily rehabilitation as documented in their clinical notes.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Series of single case experimental design studies
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Single case experimental design, which does not require sample size calculations.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2019
Actual
Date of last participant enrolment
Anticipated
15/05/2020
Actual
Date of last data collection
Anticipated
29/05/2020
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 21834 0
New Zealand
State/province [1] 21834 0
Auckland

Funding & Sponsors
Funding source category [1] 303701 0
University
Name [1] 303701 0
The University of Queensland
Country [1] 303701 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
School of Health and Rehabilitation Sciences
Level 3, Therapies Annexe (84A)
St Lucia QLD, 4072
Australia
Country
Australia
Secondary sponsor category [1] 303834 0
None
Name [1] 303834 0
N/A
Address [1] 303834 0
N/A
Country [1] 303834 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304226 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 304226 0
Ethics committee country [1] 304226 0
New Zealand
Date submitted for ethics approval [1] 304226 0
07/02/2019
Approval date [1] 304226 0
02/07/2019
Ethics approval number [1] 304226 0
19/NTB/16
Ethics committee name [2] 304260 0
University of Queensland Human Ethics Research Committee
Ethics committee address [2] 304260 0
Ethics committee country [2] 304260 0
Australia
Date submitted for ethics approval [2] 304260 0
14/07/2019
Approval date [2] 304260 0
12/08/2019
Ethics approval number [2] 304260 0
2019001614

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96198 0
Miss Jessica Tranter
Address 96198 0
Jessica Tranter
Speech Language Therapy
Allied Health Inpatients
North Shore Hospital
Waitemata District Health Board
124 Shakespeare Road
Takapuna 0620
Auckland
New Zealand

Country 96198 0
New Zealand
Phone 96198 0
+64 210627168
Fax 96198 0
Email 96198 0
[email protected]
Contact person for public queries
Name 96199 0
Jessica Tranter
Address 96199 0
Jessica Tranter
Speech Language Therapy
Allied Health Inpatients
North Shore Hospital
Waitemata District Health Board
124 Shakespeare Road
Takapuna 0620
Auckland
New Zealand
Country 96199 0
New Zealand
Phone 96199 0
+64 210627168
Fax 96199 0
Email 96199 0
[email protected]
Contact person for scientific queries
Name 96200 0
Jessica Tranter
Address 96200 0
Jessica Tranter
Speech Language Therapy
Allied Health Inpatients
North Shore Hospital
Waitemata District Health Board
124 Shakespeare Road
Takapuna 0620
Auckland
New Zealand
Country 96200 0
New Zealand
Phone 96200 0
+64 210627168
Fax 96200 0
Email 96200 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.