Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000125628
Ethics application status
Approved
Date submitted
23/01/2014
Date registered
3/02/2014
Date last updated
22/11/2019
Date data sharing statement initially provided
22/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficient and effective management of stiffness following immobilisation of simple phalangeal and metacarpal fractures.
Scientific title
A randomised trial comparing the efficiency and effectiveness of educational exercise handouts and one on one hand physiotherapy in managing stiffness following immobilisation of simple phalangeal and metacarpal fractures in children aged 5 to 16 years.
Secondary ID [1] 283975 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
simple, undisplaced phalanx fractures of the hand
 291002 0
simple, undisplaced metacarpal fractures of the hand 291019 0
Condition category
Condition code
Physical Medicine / Rehabilitation 291348 291348 0 0
Physiotherapy
Public Health 291363 291363 0 0
Health service research
Injuries and Accidents 291395 291395 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following removal of their plaster cast, baseline assessments will be performed. Group 1 will then receive an educational handout from the plastics registrar that advises on how to self manage their hand now that their hand is no longer immobilised. Participants will be re-assessed at 2 weeks post.
Intervention code [1] 288663 0
Rehabilitation
Comparator / control treatment
Following removal of their plaster cast, baseline assessments will be performed. Group 2 will receive the same handout that advises on how to self manage their hand now that their hand is no longer immobilised, but will also have one, one-on-one physiotherapy session (approximately 30 minutes) to supplement the handout. Participants will be re-assessed at 2 weeks post.
Control group
Active

Outcomes
Primary outcome [1] 291343 0
Functional outcome measured using the Upper Limb Functional Index with three point response (ULFI-3 point) (Gabel et al. 2006).
Timepoint [1] 291343 0
2 week follow up
Primary outcome [2] 291358 0
Composite flexion (fist) and hook grip as compared to the other side measured using distance measured in mm from tip of index finger to palm and reported as a ratio of injured to uninjured side.
Timepoint [2] 291358 0
2 week follow up
Primary outcome [3] 291359 0
Active range of motion (AROM) i.e. flexion and extension; which would include metacarpal phalangeal joints (MCPJ), proximal interphalangeal joints (PIPJ) and distal interphalangeal joints (DIPJ) of the injured finger and the contralateral side. This will be measured using standard goniometry and will give us the total active motion (TAM) as a percent as described by the American Society for Surgery of the Hand, 1984.
Timepoint [3] 291359 0
2 week follow up
Secondary outcome [1] 306560 0
Wrist AROM of flexion and extension measured using a goniometer in standardised positions.
Timepoint [1] 306560 0
2 weeks post
Secondary outcome [2] 306589 0
Strength of power grip and lateral pinch, measured in Newtons using a calibrated Jamar dynamometer in standardized positions.
Timepoint [2] 306589 0
2 weeks follow up
Secondary outcome [3] 306590 0
A brief parent satisfaction survey to ascertain their child’s return to normal function and activities as well as their opinion with regards to the wait times. The survey used has been prepared specifically for this study.
Timepoint [3] 306590 0
2 weeks post
Secondary outcome [4] 306591 0
Pain scores with Active Range of Movement (AROM) and activities using 10 point Visual Analogue Scale
Timepoint [4] 306591 0
2 weeks post
Secondary outcome [5] 306648 0
Consumer review of the handout using an evaluation template specifically developed for the study.
Timepoint [5] 306648 0
2 weeks post

Eligibility
Key inclusion criteria
Simple phalange or metacarpal fractures that are neither angulated nor displaced.
Stable fractures that are mildly displaced that did not require manipulation under anaesthetic (MUA).
Phalange shaft fracture with resultant axial angulations up to 10 degrees and no rotational deformity is accepted. Metacarpal neck fracture of 5 degrees to 30 degrees angulations (Bernstein and Chung 2006).
Stable fractures that are displaced and requiring MUA to achieve an acceptable anatomical alignment that is maintained without requiring internal fixation.
Minimum age
5 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Displaced/angulated fracture that require MUA and requiring internal fixation
Any associated soft tissue injuries e.g. Mallet, Central slip or Ulnar collateral ligament strain (UCL)
Open wounds or lacerations i.e. open fractures e.g. Seymour’s fracture

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
This is a non-inferiority study. We hypothesised that utilising a physiotherapy handout for education and self management post immobilisation (Group 1) for simple and undisplaced phalanx and metacarpal fractures is adequate to achieve full active range of motion and function compared with a one-on-one hand therapy by a physiotherapist (Group 2). The null hypothesis is that Group 1 is inferior to Group 2 and the alternative hypothesis is that Group 1 is not inferior to Group 2. The proportion of full active range of motion and function after two weeks with Group 2 is approximately >95%. With a margin of equivalence of 0.1 we need a sample size of 60 in each of the two groups to have a power of 83% for the non-inferiority study, at a significance of 0.05.

Non-inferiority design analysis method will be employed. The difference of the proportion of full active range of motion and function after two weeks, with the corresponding 90% confidence interval between the two groups will be calculated. We will also compare the difference for several continuous outcome variables such as pain scores and categorical variables between the two groups using independent sample T test and Chi-square test, respectively. For paired outcome variables general linear model with repeated measures will be utilised. Data will be analysed using SPSS.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/04/2014
Actual
1/12/2014
Date of last participant enrolment
Anticipated
31/08/2015
Actual
31/08/2015
Date of last data collection
Anticipated
Actual
6/10/2015
Sample size
Target
120
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 288604 0
Charities/Societies/Foundations
Name [1] 288604 0
Princess Margaret Hospital Foundation
Country [1] 288604 0
Australia
Primary sponsor type
Hospital
Name
Princess Margaret hospital
Address
Roberts Road
SUBIACO WA 6008
Country
Australia
Secondary sponsor category [1] 287314 0
None
Name [1] 287314 0
Address [1] 287314 0
Country [1] 287314 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290466 0
Child and Adolescent Health Ethics Committee
Ethics committee address [1] 290466 0
Ethics committee country [1] 290466 0
Australia
Date submitted for ethics approval [1] 290466 0
13/01/2014
Approval date [1] 290466 0
19/06/2014
Ethics approval number [1] 290466 0
2014011EP

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

Contacts
Principal investigator
Name 45834 0
Ms Cheng TAN
Address 45834 0
Physiotherapy Department, Perth Children's Hospital, 15 Hospital Road, Nedlands. WA. 6909
Country 45834 0
Australia
Phone 45834 0
+61 8 6456 0412
Fax 45834 0
Email 45834 0
[email protected]
Contact person for public queries
Name 45835 0
Cheng TAN
Address 45835 0
Physiotherapy Department, Perth Children's Hospital, 15 Hospital Road, Nedlands. WA. 6909
Country 45835 0
Australia
Phone 45835 0
+61 8 6456 0412
Fax 45835 0
Email 45835 0
[email protected]
Contact person for scientific queries
Name 45836 0
Noula Gibson
Address 45836 0
Physiotherapy Department, Perth Children's Hospital, 15 Hospital Road, Nedlands. WA. 6909
Country 45836 0
Australia
Phone 45836 0
+61 8 6456 0412
Fax 45836 0
Email 45836 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5815Study protocol  [email protected]
5816Informed consent form  [email protected]
5817Ethical approval  [email protected]



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.