Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000571673
Ethics application status
Approved
Date submitted
23/05/2014
Date registered
28/05/2014
Date last updated
28/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Word retrieval in primary progressive aphasia
Scientific title
Is a structured therapy programme aimed at improving word retrieval for people with primary progressive aphasia successful in improving naming of treated items and do gains generalize to untreated items?
Secondary ID [1] 284644 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary progressive aphasia 291960 0
Condition category
Condition code
Neurological 292312 292312 0 0
Dementias
Physical Medicine / Rehabilitation 292343 292343 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment period for each participant will span 4 weeks, in addition to two weeks of initial baseline assessment, involving two 90 minute therapy sessions per week, delivered on an individual basis. The self-cueing approach will consist of a hierarchy of semantic, phonological and orthographic cues intended to train lexical retrieval strategies and will be administered by the student researcher. 120 treatment items will be trained across the intervention period. The stimuli will consist of 10 nouns, 10 verbs and 10 adjectives. Items will be controlled across categories for frequency, length and imageability.

In addition to two weekly sessions, each participant will be assigned home practice to compliment learning in therapy. This will increase the repetition of lexical retrieval, consistent with the intensity of practice principle of neural plasticity (Kleim & Jones, 2008). Homework will include picture naming of the target items in the category for that particular week. Participants will be required to complete homework for 30 minutes on the days without therapy. Each participant will be required to document on a form their completion of the homework, including details of the time, support required and number of attempts. A spouse/significant other will assist the participant during these sessions to support word retrieval and motivation.
Intervention code [1] 289429 0
Rehabilitation
Intervention code [2] 289448 0
Treatment: Other
Comparator / control treatment
A multiple baseline design will be used with each participant acting as their own control.
Control group
Active

Outcomes
Primary outcome [1] 292177 0
The 120 items will be re-assessed post treatment using a naming battery of black and white line drawings (nouns, verbs & adjectives)
Timepoint [1] 292177 0
One week immediately post the 4-week treatment (single time point)
Secondary outcome [1] 308363 0
The Mini Mental State Examination will be repeated post treatment to assess cognitive function
Timepoint [1] 308363 0
One week immediately post the 4-week treatment
Secondary outcome [2] 308364 0
A word finding self-assessment questionnaire will be administered post treatment. This has been developed for the study and is not a validated tool.
Timepoint [2] 308364 0
One week immediately post the 4-week treatment
Secondary outcome [3] 308380 0
Curtin University Discourse Profile
Timepoint [3] 308380 0
One week immediately post the 4-week treatment

Eligibility
Key inclusion criteria
Individuals are required to have a working diagnosis of Primary Progressive Aphasia (PPA) or progressive language impairment, established from previous diagnostic evaluation by a neurologist. All variants of PPA and language profiles will be accepted into the study. Participants are required to have English as their first language and no significant hearing problems that may impact their participation in the intervention. Participants will be in the early to mid-stages of PPA, as determined by a mild-moderate score on the Mini Mental State Examination (MMSE, Folstein, Folstein, & McHugh, 1975). Participants and their spouse/carer will be required to have capacity to consent themselves to their involvement in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to give informed consent to participate

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)
Seven adults with a history of progressive language impairment / diagnosis of PPA will be recruited to the study via private neurologists working in Perth, Western Australia and the Curtin Adult Speech Pathology Clinic.
Participants will be assigned to one of two treatment blocks, consisting of the same intervention but at different times.
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
Single group
Other design features
Multiple baseline case study design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Changes in accuracy of lexical retrieval of treated items, pre-treatment, post treatment and four weeks maintenance, will be determined for each participant using Cochran’s Q test, with follow up comparisons between particular conditions using the McNemar test. Changes in accuracy of lexical retrieval of control items, pre-treatment, post treatment and four weeks maintenance, will be determined for each participant using Cochran’s Q test, with follow up comparisons between particular conditions using the McNemar test. Outcomes for different participant profiles will be analysed descriptively.

Given that PPA is a relatively rare clinical syndrome, the sample size was selected based on typical presentation / referral patterns in Western Australia. Given the case series design a sample of 7 participants was deemed appropriate.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/05/2014
Actual
21/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
7
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 289276 0
University
Name [1] 289276 0
Curtin University
Country [1] 289276 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987
Perth, WA, 6845
Country
Australia
Secondary sponsor category [1] 287942 0
Other Collaborative groups
Name [1] 287942 0
Neurodegenerative Disorders Research Pty Ltd
Address [1] 287942 0
4 Lawrence Avenue, West Perth WA 6005
Country [1] 287942 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291039 0
Curtin University HREC
Ethics committee address [1] 291039 0
Ethics committee country [1] 291039 0
Australia
Date submitted for ethics approval [1] 291039 0
Approval date [1] 291039 0
10/04/2014
Ethics approval number [1] 291039 0
HR60/2014

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

Contacts
Principal investigator
Name 48598 0
Ms Jade Cartwright
Address 48598 0
Curtin University
GPO Box U1987
Perth, WA, 6000
Country 48598 0
Australia
Phone 48598 0
+61892663039
Fax 48598 0
Email 48598 0
[email protected]
Contact person for public queries
Name 48599 0
Jade Cartwright
Address 48599 0
Curtin University
GPO Box U1987
Perth, WA, 6000
Country 48599 0
Australia
Phone 48599 0
+61892663039
Fax 48599 0
Email 48599 0
[email protected]
Contact person for scientific queries
Name 48600 0
Anne Whitworth
Address 48600 0
Curtin University
GPO Box U1987
Perth, WA, 6000
Country 48600 0
Australia
Phone 48600 0
Tel: +61892663498
Fax 48600 0
Email 48600 0
[email protected]

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.