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Trial registered on ANZCTR


Registration number
ACTRN12608000309381
Ethics application status
Approved
Date submitted
19/06/2008
Date registered
30/06/2008
Date last updated
12/11/2018
Date data sharing statement initially provided
12/11/2018
Date results provided
12/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Do dynamic splints reduce wrist stiffness following fracture?
Scientific title
For wrist stiffness following fracture, will the addition of a dynamic splint to exercises and advice improve range of motion and function?
Secondary ID [1] 594 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wrist fracture 3285 0
Stiffness 3286 0
Condition category
Condition code
Physical Medicine / Rehabilitation 3448 3448 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The dynamic splint is custom-made for the subject with thermoplastic. There is an axis about the wrist joint, and a force is applied into wrist extension with rubber band traction. The fingers and thumb will be free to move, and the subjects will be encouraged to use their hands for activities of daily living with the splint on wherever possible. Subjects will be instructed to wear the splint for more than 6 hours per day, (with total time of wear recorded) for 8 weeks. The subjects in the intervention group will also receive exercise and advice, as per the control group.
The exercises will involve active range of motion and stretches into wrist extension, flexion, radial deviation, and ulnar deviation, as well as forearm pronation and supination. Subjects will be asked to perform the exercises three times per day, with ten repetitions per type of exercise for 8 weeks.
The advice will be verbally given. Guidelines for advice to the patient will include using the involved upper limb for activities of daily living as much as possible, together with advice and reassurance relating to situations which may involve discomfort resulting from the exercises or activities of daily living. The type of advice and manner of delivery best reflects current clinical practice.
In this way, the effectiveness of a dynamic splint over and above exercise and advice can be determined.
Intervention code [1] 3023 0
Rehabilitation
Comparator / control treatment
Exercise and advice will be used as the control treatment. The exercises will involve active range of motion and stretches into wrist extension, flexion, radial deviation, and ulnar deviation, as well as forearm pronation and supination. Subjects will be asked to perform the exercises three times per day, with ten repetitions per type of exercise for 8 weeks.
The advice will be verbally given. Guidelines for advice to the patient will include using the involved upper limb for activities of daily living as much as possible, together with advice and reassurance relating to situations which may involve discomfort from exercises or activities of daily living. The type of advice and manner of delivery best reflects current clinical practice.
Control group
Active

Outcomes
Primary outcome [1] 4341 0
Passive range of motion with standardised torque
Timepoint [1] 4341 0
Measures taken at recruitment, two months of intervention, and one month post cessation of all interventions.
Primary outcome [2] 4342 0
Patient rated hand and wrist evaluation. Validated questionnaire for patient restrcition.
Timepoint [2] 4342 0
Questionnaire taken at recruitment, two months, and one month post cessation of all interventions.
Secondary outcome [1] 7315 0
Active range of extension, flexion, radial deviation, and ulnar deviation of the wrist using a goniometer.
Timepoint [1] 7315 0
Measures taken at recruitment, two months of intervention, and one month post cessation of all interventions.
Secondary outcome [2] 7316 0
Canadian Outcome Performance Measure. Client centred interview of self-perceived peformance.
Timepoint [2] 7316 0
Interview given at recruitment, two months, and one month post cessation of all interventions.

Eligibility
Key inclusion criteria
- Have sustained a fracture to the wrist at least ten weeks prior to inclusion. The fracture must be healed (united) at the time of recruitment.
- Have been referred to physiotherapy by a consultant hand surgeon.
- Have a unilateral injury.
- Have wrist stiffness evident by loss of passive range of motion compared to the contralateral wrist.
- Be living in the Sydney Metropolitan Area.
- Be willing/likely to cooperate with the intervention.
- Be over the age of 18.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects will be excluded from the study if they are unable to tolerate wearing a splint.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
1/08/2008
Actual
1/06/2009
Date of last participant enrolment
Anticipated
Actual
30/12/2011
Date of last data collection
Anticipated
Actual
30/03/2012
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 3496 0
Self funded/Unfunded
Name [1] 3496 0
Country [1] 3496 0
Primary sponsor type
Hospital
Name
Royal North Shore Hospital
Address
Pacific Highway
St Leonards
NSW 2065
Country
Australia
Secondary sponsor category [1] 3139 0
University
Name [1] 3139 0
University of Sydney
Address [1] 3139 0
Rehabilitation Studies Unit, PO Box 6, Ryde NSW 1680
Country [1] 3139 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5533 0
Northern Sydney Health Human Research Ethics Committee (EC00333)
Ethics committee address [1] 5533 0
Ethics committee country [1] 5533 0
Australia
Date submitted for ethics approval [1] 5533 0
Approval date [1] 5533 0
22/05/2008
Ethics approval number [1] 5533 0
0803-027M

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

Contacts
Principal investigator
Name 28680 0
Prof Lisa Harvey
Address 28680 0
John Walsh Centre for Rehabilitation Research

THE UNIVERSITY OF SYDNEY
Kolling Institute of Medical Research
Royal North Shore Hospital
St Leonards NSW
2065 AUSTRALIA
Country 28680 0
Australia
Phone 28680 0
+61 2 9926 4962
Fax 28680 0
Email 28680 0
lisa.harvey@sydney.edu.au
Contact person for public queries
Name 11837 0
Ray Jongs
Address 11837 0
Physiotherapy Department
Building 30
Royal North Shore Hospital
Reserve Road
St Leonards NSW 2065
Country 11837 0
Australia
Phone 11837 0
+61 2 9926 7556
Fax 11837 0
Email 11837 0
ray.jongs@health.nsw.gov.au
Contact person for scientific queries
Name 2765 0
Lisa Harvey
Address 2765 0
John Walsh Centre for Rehabilitation Research

THE UNIVERSITY OF SYDNEY
Kolling Institute of Medical Research
Royal North Shore Hospital
St Leonards NSW
2065 AUSTRALIA
Country 2765 0
Australia
Phone 2765 0
+61 2 9926 4594
Fax 2765 0
Email 2765 0
lisa.harvey@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.