Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000204448
Ethics application status
Approved
Date submitted
2/04/2007
Date registered
13/04/2007
Date last updated
16/02/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of an advice and exercise program on patients with distal radius fractures
Scientific title
The effect of an advice and exercise program on range, strength, pain and function of patients with distal radius fractures
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Distal radius fractures 1729 0
Condition category
Condition code
Injuries and Accidents 1820 1820 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment group: receive verbal instruction and standardised written advice and an exercise program from a physiotherapist. This is given at the time of, or within one week of, plaster removal at an out-patient appointment. Subjects are instructed to peform range of motion exercises immediately following removal of plaster, 5 times every hour during the day. Stretching exercises begin 2 weeks after plaster removal and involve 3-4 stretches hourly. Strengthening exercises begin 3 weeks after plaster removal and involve up to 12 repetitions twice per day. Patients are instructed to continue these exercises until they feel their hand/wrist has returned to normal.
Intervention code [1] 1685 0
Treatment: Other
Comparator / control treatment
Control group: receive no physiotherapy intervention.
Control group
Active

Outcomes
Primary outcome [1] 2551 0
Goniometric range of movement of wrist
Timepoint [1] 2551 0
Measured at baseline, 3 and 6 weeks
Secondary outcome [1] 4395 0
Grip strength using Jamar dynanometer
Timepoint [1] 4395 0
Measured at baseline, 3 and 6 weeks.
Secondary outcome [2] 4396 0
Function using the Quick Disabilities of Arm, Shoulder and Hand (DASH).
Timepoint [2] 4396 0
Measured at baseline, 3 and 6 weeks.
Secondary outcome [3] 4397 0
Pain using Patient Rated Wrist Hand Evaluation (PRWE).
Timepoint [3] 4397 0
Measured at baseline, 3 and 6 weeks.

Eligibility
Key inclusion criteria
Patients with distal radius fractures managed with plaster and/or pins.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Fractures treated with external fixation or open reduction and internal fixation, concurrent fractures, pre-existing inflammatory joint conditions.

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 by contacting the primary researcher who is at a central administration site and has an allocation schedule which is referred to once patient's eligibility and willingness to participate is ascertained
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomisation by using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
assessor is blinded, data analyst is blinded
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1972 0
Hospital
Name [1] 1972 0
Royal Adelaide Hospital Allied Health Research Grant
Country [1] 1972 0
Australia
Primary sponsor type
Individual
Name
Sandra Kay, Physiotherapy Department, Royal Adelaide Hospital
Address
Physiotherapy Department, RAH, North Tce, Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 1784 0
Individual
Name [1] 1784 0
Kathy Stiller
Address [1] 1784 0
Physiotherapy Department, RAH, North Tce, Adelaide, SA 5000
Country [1] 1784 0
Australia
Secondary sponsor category [2] 1785 0
Individual
Name [2] 1785 0
Margaret McMahon
Address [2] 1785 0
Physiotherapy Department, RAH, North Tce, Adelaide, SA 5000
Country [2] 1785 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3667 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 3667 0
Ethics committee country [1] 3667 0
Australia
Date submitted for ethics approval [1] 3667 0
Approval date [1] 3667 0
31/10/2005
Ethics approval number [1] 3667 0
010819

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

Contacts
Principal investigator
Name 27788 0
Address 27788 0
Country 27788 0
Phone 27788 0
Fax 27788 0
Email 27788 0
Contact person for public queries
Name 10874 0
Sandra Kay
Address 10874 0
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 10874 0
Australia
Phone 10874 0
+61 8 82225334
Fax 10874 0
+61 8 82224279
Email 10874 0
[email protected]
Contact person for scientific queries
Name 1802 0
Sandra Kay
Address 1802 0
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 1802 0
Australia
Phone 1802 0
+61 8 82225334
Fax 1802 0
+61 8 82224279
Email 1802 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.