Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001135909
Ethics application status
Approved
Date submitted
31/10/2011
Date registered
31/10/2011
Date last updated
31/10/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of a Home-Based Program to improve Handwriting Legibility After Stroke: A Pilot Randomised Trial
Scientific title
Feasibility of a Home-Based Occupational Therapy Handwriting Retraining Program to improve Handwriting Legibility in Adults After Stroke: A Pilot Randomised Trial
Secondary ID [1] 273293 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor handwriting performance due to hemiplegia after stroke, including reduced handwriting legibility, pen control and speed 279057 0
Condition category
Condition code
Stroke 279247 279247 0 0
Ischaemic
Stroke 279249 279249 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 279265 279265 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 4 week home-based handwriting retraining program, with 2 occupational therapy coaching sessions and 3 independent practice sessions per week, approximately 60 minutes per session.
Intervention code [1] 283640 0
Rehabilitation
Comparator / control treatment
Usual rehabilitation (without handwriting retraining)
Control group
Active

Outcomes
Primary outcome [1] 279879 0
Handwriting legibility, measured using legibility subtest of the Handwriting Assessment Battery (HAB)
Timepoint [1] 279879 0
Baseline, immediately after intervention ceases (4 weeks), and 3 months after intervention ceases
Secondary outcome [1] 294648 0
Writing speed (subtest of HAB)
Timepoint [1] 294648 0
Baseline, immediately after intervention ceases (4 weeks), and 3 months after intervention ceases
Secondary outcome [2] 294649 0
Pen control (subtest of HAB)
Timepoint [2] 294649 0
Baseline, immediately after intervention ceases (4 weeks), and 3 months after intervention ceases
Secondary outcome [3] 294650 0
Self reported perception of, and satisfaction with handwriting performance, using Modified Disabilities of the Arm, Shoulder and Hand scale
Timepoint [3] 294650 0
Baseline, immediately after intervention ceases (4 weeks), and 3 months after intervention ceases

Eligibility
Key inclusion criteria
To be eligible, participants need to:
Be living in the Sydney metropolitan area
Had a stroke at least 6 months prior to baseline assessment
Have difficulties with handwriting
Be able to follow instructions and complete a home program independently or with support of a family member
Be able to speak, write and read in English
Cease other therapy related to handwriting or similar tasks during the study and follow-up period
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Moderate to severe apraxia

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 schedule will be prepared by a researcher not otherwise involved in recruitment, and held in sealed, opaque envelopes by a third party not otherwise involved in the study. Consent will be obtained prior to collecting baseline measures. Participant will then be considered recruited, and group allocation will be obtained by phoning the third party.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This is a pilot, feasibility study. Data will be used to inform planning of a larger randomised controlled trial in the future.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/11/2011
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] 4660 0
2095
Recruitment postcode(s) [2] 4661 0
2122
Recruitment postcode(s) [3] 4662 0
2067
Recruitment postcode(s) [4] 4663 0
2750
Recruitment postcode(s) [5] 4664 0
2233
Recruitment postcode(s) [6] 4665 0
2000
Recruitment postcode(s) [7] 4666 0
2780
Recruitment postcode(s) [8] 4667 0
2170

Funding & Sponsors
Funding source category [1] 284119 0
Charities/Societies/Foundations
Name [1] 284119 0
National Stroke Foundation
Country [1] 284119 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country
Australia
Secondary sponsor category [1] 269082 0
None
Name [1] 269082 0
Address [1] 269082 0
Country [1] 269082 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272078 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 272078 0
Level 6, Jane Foss Russell Building - G02
The University of Sydney
NSW 2006 AUSTRALIA
Ethics committee country [1] 272078 0
Australia
Date submitted for ethics approval [1] 272078 0
02/08/2011
Approval date [1] 272078 0
03/08/2011
Ethics approval number [1] 272078 0
08-2011 / 13945

Summary
Brief summary
Handwriting performance is often impaired after a stroke. Although task-specific upper limb practice can improve outcomes, the effectiveness of adult handwriting retraining has not been investigated. The aim of this study is to test the feasibility of a 4-week retraining program to improve handwriting performance using a pilot randomised trial design. Concealed allocation, blinded assessors and intention to treat analysis will be used. A community sample of 20 people with stroke will be randomly allocated to receive either 4 weeks of tailored handwriting retraining with twice weekly coaching sessions at home, or usual care. Outcomes will be obtained by a blinded assessor at baseline, and 4 weeks and 3 months post-intervention.
Trial website
None
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33326 0
Address 33326 0
Country 33326 0
Phone 33326 0
Fax 33326 0
Email 33326 0
Contact person for public queries
Name 16573 0
Bronwyn Simpson
Address 16573 0
Discipline of Occupational Therapy, Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 16573 0
Australia
Phone 16573 0
+61430125223
Fax 16573 0
Email 16573 0
[email protected]
Contact person for scientific queries
Name 7501 0
Annie McCluskey
Address 7501 0
Discipline of Occupational Therapy, Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 7501 0
Australia
Phone 7501 0
+61 2 9351 9834
Fax 7501 0
Email 7501 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.