Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000980033
Ethics application status
Approved
Date submitted
10/11/2010
Date registered
12/11/2010
Date last updated
13/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Intensive Home Based Speech Pathology Intervention on Speech, Swallowing and Quality of Life for Stroke Survivors.
Scientific title
Stroke survivors with intensive therapy delivered by an assistant, compared to treatment as usual by a speech pathologist show gains in quality of life and oral motor performance.
Secondary ID [1] 253082 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysarthria 256779 0
dysphagia 256780 0
oral/verbal dyspraxia 256781 0
Condition category
Condition code
Stroke 256925 256925 0 0
Ischaemic
Stroke 256926 256926 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individual treatment package delivered by a therapy assistant focusing on oral motor rehabilitation, behavioural techniques and education with functional (home and community) practice. Treatment is offered daily - up to one hour of therapy as tolerated by the patient. They are offered a maximum of 15 sessions of therapy over 3 weeks.
Patient records all their home practice.
Intervention code [1] 255985 0
Rehabilitation
Comparator / control treatment
treatment as usual - Individual treatment delivered by a speech pathologist with a self directed home exercise package. Patient records all their home practice. Therapy sessions are as required and at the therapists discretion and based on the patients needs/goals. They are offered three weeks of therapy.
Control group
Active

Outcomes
Primary outcome [1] 257801 0
Oral motor and inttelligibility outcomes - Frenchary Dysarthria Assessment
Timepoint [1] 257801 0
immediately post therapy (3 weeks), 3 months post therapy and if possible 6 months post therapy.
Primary outcome [2] 259650 0
A range of oral motor and speech intelligibility and swallowing assessments.
Timepoint [2] 259650 0
Pre therapy, post therapy three months post initial assessment, six months post initial assessment.
Secondary outcome [1] 263215 0
Quality of life - Dysarthria Impact Profile, SWAL - QOL.
Timepoint [1] 263215 0
immediately post therapy (3 weeks), 3 months post therapy and if possible 6 months post therapy.
Secondary outcome [2] 266391 0
Carer Satisfaction Questionnaire - A set questionnaire to be either written by carer or with a verbal interview by the reseracher to be conducted for each main carer for each patient recruited.
Timepoint [2] 266391 0
Questionnaire to be given after therapy finishes and before the three month re-assessment.
Secondary outcome [3] 266392 0
therapy assistant questionnaire
Timepoint [3] 266392 0
pre and post therapy.
Secondary outcome [4] 266393 0
speech pathology questionnaire
Timepoint [4] 266393 0
Post therapy
Secondary outcome [5] 266394 0
Patient Home Practice Record Journal
Timepoint [5] 266394 0
every day during therapy the journal is updated

Eligibility
Key inclusion criteria
New diagnosis of stroke with a diagnosis of dysarthria, oral dysphagia and/or oral/verbal dyspraxia.
General Royal Perth Hospital Rehabilitation in the Home acceptance criteria
Minimum age
18 Years
Maximum age
110 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-stroke dementia
Severe oral/verbal dyspraxia and unable to vocalise
Severe dysphasia

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants are randomly allocated to receive either one intervention by a therapy assistant or treatment as usual by a speech pathologist.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2571 0
6000

Funding & Sponsors
Funding source category [1] 256488 0
Charities/Societies/Foundations
Name [1] 256488 0
National Stroke Foundation
Country [1] 256488 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
National Stroke Foundation
Address
National Stroke Foundation
Level 7/461 Bourke Street, Melbourne, Vic 3000
T +61 3 9670 1000 | F +61 3 9670 9300 |
Country
Australia
Secondary sponsor category [1] 257236 0
None
Name [1] 257236 0
Address [1] 257236 0
Country [1] 257236 0
Other collaborator category [1] 1118 0
Hospital
Name [1] 1118 0
Royal Perth Hospital
Address [1] 1118 0
Wellington Street
Perth WA 6000
Country [1] 1118 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258538 0
Royal Perth Hospital
Ethics committee address [1] 258538 0
Wellington Street Campus
PERTH WA 6000
Ethics committee country [1] 258538 0
Australia
Date submitted for ethics approval [1] 258538 0
02/02/2010
Approval date [1] 258538 0
09/04/2010
Ethics approval number [1] 258538 0
EC 2010-023.

Summary
Brief summary
Communication and swallowing difficulties are a common sequelae for people who have suffered a stroke. These difficulties can affect interpersonal relationships, self image and community reintegration. This project is designed to evaluate the effect of a treatment program on the speech,
swallowing and quality of life of stroke survivors when delivered by a therapy assistant in a home based setting.
The intensive treatment program will include education, behavioural intervention and oral motor rehabilitation, with functional speech or swallowing practice. It is anticipated that patients who have intensive treatment will achieve improved outcomes in swallowing status and speech intelligibility as well as self-confidence and independence. Stroke survivor details will be collected and analysed with frequency of treatment and home practice to determine any barriers to treatment delivery and ability to practice on their own.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30783 0
Address 30783 0
Country 30783 0
Phone 30783 0
Fax 30783 0
Email 30783 0
Contact person for public queries
Name 14030 0
Katy Hackling
Address 14030 0
Box X2213 GPO Perth WA 6847
Country 14030 0
Australia
Phone 14030 0
+61 8 6477 5152
Fax 14030 0
Email 14030 0
katy.stewart@health.wa.gov.au or khackling@hotmail.com
Contact person for scientific queries
Name 4958 0
Katy Hackling
Address 4958 0
Box X2213 GPO Perth WA 6847
Country 4958 0
Australia
Phone 4958 0
+61 8 6477 5152
Fax 4958 0
Email 4958 0
katy.stewart@health.wa.gov.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.