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Trial registered on ANZCTR


Registration number
ACTRN12614000033640
Ethics application status
Approved
Date submitted
2/01/2014
Date registered
10/01/2014
Date last updated
3/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Is reading therapy effective for people who have reading difficulties related to impaired cognition and language after stroke?
Scientific title
Does reading therapy for people who have reading difficulties related to impaired cognition and language after stroke result in increased reading speed, reading accuracy, reading comprehension, confidence and language abilities?
Secondary ID [1] 283828 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 290805 0
Condition category
Condition code
Stroke 291174 291174 0 0
Ischaemic
Stroke 291177 291177 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Therapy will be tailored to the individual participant. It will focus on reading material of the participant’s choice. Goals will be determined with the client and the therapy will be tailored to meet those goals. The client’s reading profile will influence the therapy approach adopted. Methods used will be similar to those used at the City University London Reading Clinic including highlighting words, using mind maps, creating summaries of chapters on post-it notes etc. Participants will attend 12-13 therapy sessions, 1 session per week for 1 hr. Ideally, all participants would have been seen at the student clinic but the student clinic only has capacity for 10 clients and only runs one day a week, in order to increase the numbers of clients that could be seen at the clinic and increase the flexibility of the days that therapy is offered we sought funding for a research assistant to see an additional 5 participants. There will be no difference in the type of therapy that will be provided by the students and the research assistant.
Intervention code [1] 288514 0
Rehabilitation
Comparator / control treatment
This is a within subject design and there is no comparator/control treatment.

There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291160 0
Composite outcome of increased reading speed, reading comprehension, reading accuracy (as indicated by Gray Oral Reading Tests -5th addition(GORT-V)
Timepoint [1] 291160 0
Assessment will consist of:
-Three pre-therapy assessments: an initial baseline assessment (A1) spread over two sessions, a second baseline assessment one month later (A2) and an additional assessment session one week later (A3).
-Two post-therapy assessments: one week after therapy is completed (A4) spread over two sessions and one a month after therapy is completed (A5) in order to determine whether gains have been maintained
Primary outcome [2] 291227 0
Increased verbal language (as indicated by Western Aphasia Battery Revised (WAB-R scores)
Timepoint [2] 291227 0
Assessment will consist of:
-Three pre-therapy assessments: an initial baseline assessment (A1) spread over two sessions, a second baseline assessment one month later (A2) and an additional assessment session one week later (A3).
-Two post-therapy assessments: one week after therapy is completed (A4) spread over two sessions and one a month after therapy is completed (A5) in order to determine whether gains have been maintained
Primary outcome [3] 291228 0
Increased reading confidence and emotions associated with reading (as indicated on the Reading, Confidence and Emotions Questionnaire- RCEQ)
Timepoint [3] 291228 0
Assessment will consist of:
-Three pre-therapy assessments: an initial baseline assessment (A1) spread over two sessions, a second baseline assessment one month later (A2) and an additional assessment session one week later (A3).
-Two post-therapy assessments: one week after therapy is completed (A4) spread over two sessions and one a month after therapy is completed (A5) in order to determine whether gains have been maintained
Secondary outcome [1] 306160 0
Nil
Timepoint [1] 306160 0
Nil

Eligibility
Key inclusion criteria
Participants will have reading difficulties associated with impaired language or cognition as a result of stroke.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
English not primary language, reading difficulties primarily due to perceptual difficulties. Less than 6 months post-stroke.

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)
There is no control group in this study and it is not a randomised control trial.

Fifteen participants with mild-moderate reading difficulties related to impaired cognition or language after stroke will be recruited from community stroke groups in Perth. Ten participants will attend the student clinic and an additional five will be seen by a research assistant.
Participants will participate in assessments at five time points and 12-13 therapy sessions. The assessments will consist of the following:
*Three pre-therapy assessments: an initial baseline assessment (A1) spread over two sessions, a second baseline assessment one month later (A2) and an additional assessment session one week later (A3).
* Two post-therapy sessions: one week after therapy is completed (A4) spread over two sessions and one a month after therapy is completed (A5) in order to determine whether gains have been maintained
Gray Oral Reading Assessment V (GORT-V) (Wiederholt & Bryant, 2012), and the Western Aphasia Battery- Revised (WAB-R) (Kertesz, 2006) will measure changes to reading accuracy, reading speed, reading comprehension and verbal language. These will be conducted in A1, A2, A4 and A5.
The Reading Confidence and Emotions Questionnaire (RCEQ) (Cocks et al., 2013) will capture changes in confidence and emotions associated with reading and conversing about reading. This will be conducted in A1, A2, A4 and A5.
Any additional diagnostic assessments needed to confirm hypotheses about the client’s diagnoses will be carried out in A3, for example the non-word reading subtest from the Psycholinguistic Assessment of Language Processing in Aphasia (PALPA) (Kay, Coltheart, & Lesser, 1992), the Test of Everyday Attention (TEA) (Robertson, Ward, & Ridgeway, 1995). If appropriate these diagnostic assessments will be repeated in the post-therapy sessions.
Exit interviews similar to that used in Cocks et al. (2013) will be conducted in A5. These will capture changes to participation in reading and further information about changes to confidence and emotions associated with reading. Questions will include: “Have you noticed any changes with your reading or your communication since you started coming to the clinic?” “What did you like/not like about therapy?” “Have there been any changes to activities you participate in outside of clinic that you think is a result of attending the clinic?”
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will not be randomised.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical Analysis: The type of analysis used will depend on how different the participant’s goals and therapy will be. It is most likely that participants will have different goals and so participants are most likely going to be treated as either single cases or a case series.

As this was an exploratory study and very little research has been done previously on reading therapy for people who have reading difficulties as a result of cognitive or languae impairment, sample size was determined by clinic capacity and funding available. As participants are most likely to be treated as single cases or a single case study the size of the sample was therefore not of concern.

If by chance all participants have similar goals and profiles (which is unlikely) then their results will be grouped together and a repeated measures or Friedman’s (depending on normality) ANOVAs will be used in order to capture changes in:
* reading speed, reading comprehension, reading accuracy (as indicated by GORT-V scores)
* verbal language (as indicated by WAB-R scores)
*reading confidence and emotions associated with reading (as indicated on RCEQ)

Friedman's ANOVA will most likely be used due to the small sample size and likelihood of the assumption of normality being violated.

Please note that the most likely scenario is that participants will be treated as single case studies or in a case series.

The interviews will be analysed qualitatively in order to capture recurrent themes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/01/2014
Actual
13/01/2014
Date of last participant enrolment
Anticipated
8/12/2015
Actual
8/12/2015
Date of last data collection
Anticipated
Actual
8/12/2015
Sample size
Target
15
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 288488 0
Charities/Societies/Foundations
Name [1] 288488 0
National Stroke Foundation
Country [1] 288488 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent St, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 287190 0
None
Name [1] 287190 0
Address [1] 287190 0
Country [1] 287190 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290350 0
Curtin University
Ethics committee address [1] 290350 0
Ethics committee country [1] 290350 0
Australia
Date submitted for ethics approval [1] 290350 0
Approval date [1] 290350 0
16/12/2013
Ethics approval number [1] 290350 0
HR204/2013

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

Contacts
Principal investigator
Name 45242 0
Dr Naomi Cocks
Address 45242 0
Senior Lecturer
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987 Perth,
Western Australia 6845
Country 45242 0
Australia
Phone 45242 0
+61892662466
Fax 45242 0
Email 45242 0
Naomi.cocks@curtin.edu.au
Contact person for public queries
Name 45243 0
Naomi Cocks
Address 45243 0
Senior Lecturer
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987 Perth,
Western Australia 6845
Country 45243 0
Australia
Phone 45243 0
+61892662466
Fax 45243 0
Email 45243 0
Naomi.cocks@curtin.edu.au
Contact person for scientific queries
Name 45244 0
Naomi Cocks
Address 45244 0
Senior Lecturer
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987 Perth,
Western Australia 6845
Country 45244 0
Australia
Phone 45244 0
+61892662466
Fax 45244 0
Email 45244 0
Naomi.cocks@curtin.edu.au

No information has been provided regarding IPD availability


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.