Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000230550
Ethics application status
Approved
Date submitted
6/06/2006
Date registered
6/06/2006
Date last updated
14/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does Splinting Prevent Contracture Following Stroke?
Scientific title
Hand splinting to manage contracture of the wrist and improve function, and reduce pain and spasticity of adults with hemiplegia following stroke.
Secondary ID [1] 267 0
ClinicalTrials.gov: NCT00286702
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 1208 0
Condition category
Condition code
Stroke 1293 1293 0 0
Haemorrhagic
Stroke 2417 2417 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1) Hand splint which positions the wrist in neutral, worn at night for up to 12 hours at a time for 4 weeks.
2) Hand splint which positions the wrist in extension, worn at night for up to 12 hours at a time for 4 weeks.
Intervention code [1] 1122 0
Rehabilitation
Comparator / control treatment
3) Control group who do not wear a hand splint
Control group
Active

Outcomes
Primary outcome [1] 1762 0
Muscle extensibility of the wrist and long finger flexor muscles as measured using torque controlled range of motion of wrist extension with the fingers held in extension.
Timepoint [1] 1762 0
Measured at baseline (pre-randomisation), and at 4 weeks and 6 weeks.
Secondary outcome [1] 3112 0
Function as measured using the upper limb items of the Motor Assessment Scale.
Timepoint [1] 3112 0
Measured at baseline (pre-randomisation), and at 4 weeks and 6 weeks.
Secondary outcome [2] 3113 0
Pain and Self-rated Disability as measured using the Disabilities of the Arm, Shoulder and Hand Questionnaire.
Timepoint [2] 3113 0
Measured at baseline (pre-randomisation), and at 4 weeks and 6 weeks.
Secondary outcome [3] 3114 0
Spasticity as measured using the Tardieu scale.
Timepoint [3] 3114 0
Measured at baseline (pre-randomisation), and at 4 weeks and 6 weeks.

Eligibility
Key inclusion criteria
i. Medical diagnosis of stroke, which occurred within the previous eightweeks ii.no active wrist extension iii.Sufficient cognitive and hearing function to be able to fully participate in the trial iv.Living in the Sydney metropolitan area to be seen for follow-up clinical examinations.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Previous stroke resulting in an upper limb hemiplegia.(ii) Previous upper limb trauma causing structural imbalance, or reduced range of movement, at the wrist or fingers (for example. a colles fracture).(iii) Osseous abnormality in the wrist or fingers(iv) Arthritic condition of the wrist or fingers.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation with opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
External person not involved in the study generated the sequence using Excel software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
63
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1419 0
University
Name [1] 1419 0
University of Western Sydney
Country [1] 1419 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
Locked Bag 1797
PENRITH SOUTH DC
NSW 1797
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 1245 0
Individual
Name [1] 1245 0
Professor Anne Cusick
Address [1] 1245 0
Locked Bag 1797
PENRITH SOUTH DC
NSW 1797
AUSTRALIA
Country [1] 1245 0
Australia
Secondary sponsor category [2] 1246 0
Individual
Name [2] 1246 0
Dr Annie McCluskey
Address [2] 1246 0
Cumberland Campus
The University of Sydney
NSW 2006
Australia
Country [2] 1246 0
Australia
Secondary sponsor category [3] 1247 0
Individual
Name [3] 1247 0
A/Prof Robert Herbert
Address [3] 1247 0
Cumberland Campus
The University of Sydney
NSW 2006
Australia
Country [3] 1247 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2774 0
University of Western Sydney Ethics Review Committee
Ethics committee address [1] 2774 0
Ethics committee country [1] 2774 0
Australia
Date submitted for ethics approval [1] 2774 0
Approval date [1] 2774 0
08/08/2002
Ethics approval number [1] 2774 0
01/166
Ethics committee name [2] 2775 0
Sydney Adventist Hospital Ethics Committee
Ethics committee address [2] 2775 0
Ethics committee country [2] 2775 0
Australia
Date submitted for ethics approval [2] 2775 0
Approval date [2] 2775 0
12/07/2002
Ethics approval number [2] 2775 0
Ethics committee name [3] 2776 0
St Joseph’s Hospital Quality Care Committee
Ethics committee address [3] 2776 0
Ethics committee country [3] 2776 0
Australia
Date submitted for ethics approval [3] 2776 0
Approval date [3] 2776 0
13/06/2002
Ethics approval number [3] 2776 0
Ethics committee name [4] 2777 0
South Eastern Sydney Area Health Service Human Research Ethics Committee Eastern Section
Ethics committee address [4] 2777 0
Ethics committee country [4] 2777 0
Australia
Date submitted for ethics approval [4] 2777 0
Approval date [4] 2777 0
28/08/2002
Ethics approval number [4] 2777 0
02/152
Ethics committee name [5] 2778 0
South Western Sydney Area Health Service Research Ethics Committee
Ethics committee address [5] 2778 0
Ethics committee country [5] 2778 0
Australia
Date submitted for ethics approval [5] 2778 0
Approval date [5] 2778 0
19/11/2002
Ethics approval number [5] 2778 0
02/113
Ethics committee name [6] 2779 0
St Vincent’s Hospital Sydney Human Research Ethics Committee
Ethics committee address [6] 2779 0
Ethics committee country [6] 2779 0
Australia
Date submitted for ethics approval [6] 2779 0
Approval date [6] 2779 0
07/01/2003
Ethics approval number [6] 2779 0
Q02/128
Ethics committee name [7] 2780 0
Western Sydney Area Health Service Human Research Ethics Committee
Ethics committee address [7] 2780 0
Ethics committee country [7] 2780 0
Australia
Date submitted for ethics approval [7] 2780 0
Approval date [7] 2780 0
02/03/2004
Ethics approval number [7] 2780 0
HREC2003/12/4.18(1737)

Summary
Brief summary
Contracture after stroke is a condition that causes pain and disability in adults with hemiplegia after stroke. It is commonly treated by using hand splints. This trial aimed to evaluate the effect of two types of hand splints used clinically during rehabilitation to prevent contracture: a hand splint that positions the wrist in neutral and a hand splint that positions the wrist in extension. The trial’s primary hypotheses were (i) do commonly prescribed hand splints prevent contracture in people with hemiplegia after stroke, and (ii) do commonly prescribed hand splints improve function, and reduce pain and/or spasticity in people with hemiplegia following stroke. The trial assessed changes in outcomes at four weeks (following removal of splints) and at six weeks (follow-up). All outcomes were measured by a research assistant blind to treatment group allocation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35337 0
Address 35337 0
Country 35337 0
Phone 35337 0
Fax 35337 0
Email 35337 0
Contact person for public queries
Name 10311 0
Natasha Lannin
Address 10311 0
Rehabilitation Studies Unit
PO Box 6, Ryde NSW 2112
Country 10311 0
Australia
Phone 10311 0
+61 2 98089236
Fax 10311 0
Email 10311 0
[email protected]
Contact person for scientific queries
Name 1239 0
Natasha Lannin
Address 1239 0
Rehabilitation Studies Unit
PO Box 6 Ryde NSW 2112
Country 1239 0
Australia
Phone 1239 0
+61 2 98089236
Fax 1239 0
Email 1239 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
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