Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000312640
Ethics application status
Approved
Date submitted
31/08/2005
Date registered
6/09/2005
Date last updated
22/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does three months of nightly splinting reduce thumb web-space contractures?
Scientific title
Does three months of nightly splinting reduce thumb web-space contractures in patients with neurological conditions
Secondary ID [1] 283503 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with contractures of the thumb web-space following SCI, TBI or stroke 400 0
Condition category
Condition code
Neurological 290813 290813 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three months of nightly splinting.
Intervention code [1] 288209 0
Rehabilitation
Comparator / control treatment
No Treatment
Control group
Active

Outcomes
Primary outcome [1] 535 0
Palmar abduction of the carpometacarpal joint will be measured with a device specifically designed for the purpose which uses a wheel to apply a standardised torque to the carpometacarpal joint. The carpometacarpal angle will be measured with a goniometer, the centre of which was fixed to the centre of the wheel. Both thumbs will be measured
in all participants,
Timepoint [1] 535 0
Measured immediately before and after the study period to both experimental and control participants.
Secondary outcome [1] 1141 0
Participants' perceptions about treatment effectiveness was assessed using 5 questions. Questions 1-3 were measured on a 10-point visual analogue scale with 1 was ‘not at all happy’ and 10 was ‘extremely happy’. Questions 4-5 required a yes/no response.
Timepoint [1] 1141 0
The first three questions were administered immediately before and after the study period to both experimental and control participants. The last two questions were administered immediately after the intervention period to the experimental participants only.

Eligibility
Key inclusion criteria
1. Have contractures of their thumb web-space2. have suffered a TBI, stroke or SCI3. are willing to wear a splint each night for three months4. are willing to cease all other co-interventions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Contracture is deemed too severe to manage with conservative intervention2.patient has very severe spasticity that prevents testing.

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 was computer generated by a person on involved in the study. Each participant's allocation was placed in a sealed, opaque, sequentialy numbered enveolope. The envelopes were kep at a central location and were not opened until the participant had completed all initial assessments. The participants was considered to have entered the trial at this stage.
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
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2005
Actual
11/04/2005
Date of last participant enrolment
Anticipated
Actual
23/09/2005
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 530 0
Charities/Societies/Foundations
Name [1] 530 0
Rehabilitation and Disability Research Foundation
Country [1] 530 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Royal Rehabilitation Centre Sydney
Address
PO Box 6, Ryde, NSW, 1680
Country
Australia
Secondary sponsor category [1] 431 0
University
Name [1] 431 0
Rehabilitation Studies Unit
Address [1] 431 0
PO Box 6, Ryde, NSW, 1680
Country [1] 431 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1531 0
Royal Rehabilitation Centre Sydney
Ethics committee address [1] 1531 0
Ethics committee country [1] 1531 0
Australia
Date submitted for ethics approval [1] 1531 0
Approval date [1] 1531 0
Ethics approval number [1] 1531 0

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

Contacts
Principal investigator
Name 36313 0
A/Prof Lisa Harvey
Address 36313 0
Rehabilitation Studies Unit
Royal Rehabilitation Centre Sydney
PO Box 6 Ryde NSW 1680
Country 36313 0
Australia
Phone 36313 0
+61 2 98099099
Fax 36313 0
+61 2 98099037
Email 36313 0
[email protected]
Contact person for public queries
Name 9507 0
Lisa Harvey
Address 9507 0
Rehabilitation Studies Unit
Royal Rehabilitation Centre Sydney
PO Box 6
Ryde NSW 1680
Country 9507 0
Australia
Phone 9507 0
+61 2 98099099
Fax 9507 0
+61 2 98099037
Email 9507 0
[email protected]
Contact person for scientific queries
Name 435 0
Lisa Harvey
Address 435 0
Rehabilitation Studies Unit
Royal Rehabilitation Centre Sydney
PO Box 6
Ryde NSW 1680
Country 435 0
Australia
Phone 435 0
+61 2 98099099
Fax 435 0
+61 2 98099037
Email 435 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.