Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000355976
Ethics application status
Approved
Date submitted
25/02/2020
Date registered
12/03/2020
Date last updated
12/03/2020
Date data sharing statement initially provided
12/03/2020
Date results provided
12/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The comparison of 3D printed and thermoplastic oval eight finger orthoses: A randomised crossover trial.
Scientific title
The comparison of 3D printed and thermoplastic oval eight finger orthoses in a healthy cohort, a comparison of hand function, occupational performance and satisfaction, and orthoses characteristics : A randomised crossover trial.
Secondary ID [1] 300642 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The use of this orthosis is to prevent hyper extension of the PIPJ when injured through varied conditions including central slip injury 316425 0
boutonniere deformity 316593 0
dislocation 316594 0
Rheumatoid arthritis. 316595 0
Condition category
Condition code
Physical Medicine / Rehabilitation 314684 314684 0 0
Occupational therapy
Inflammatory and Immune System 314820 314820 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants were randomised to wear either a 3D printed or a thermoplastic oval eight finger orthosis for 24-hours, given a 24-hour washout period, followed by wearing the second orthosis for a further 24-hours.
A 3D printed orthosis was created by the principal investigator, who created the orthosis initially on a CAD program and then printed via a desktop 3D printer, Lulzbot mini, using ABS 2mm filament. Each participant had there finger measured using a tape measure, at the middle and proximal phalanx of the index finger, and these measurement were input to the CAD program to create the custom made orthosis. The print time was approximately 30 minutes and then any minor rough aspects were smoothed with fine grit sandpaper.
The thermoplastic was created by the principal investigator using current best practice methods. A 10 cm piece of Aquaplast thermoplastic was heated in a heat bath at 70 degrees. Once softened the participant was asked to rest their elbow on the table with their hand directly above, the principal investigator then molded the thermoplastic to the index finger at the PIPJ, creating the currently used orthosis. Any excess thermoplastic material was cut away.
Once the two orthosis were created by the principal investigator the second investigator took all baseline measurement, with orthosis in place.
The participant was randomised to wearing one of the two orthosis initially, which they were given verbal and written instructions on correct wearing and safety. The participant then wore the orthosis for 24 hours. They were then contacted by phone by the second investigator and outcome measures taken. The participant had a 24 hour washout period of not wearing an orthosis. The participant then wore the second of the two orthosis for a further 24 hours, again at the end of the wear period they were contact by phone by the second investigator to complete the outcome measures.
The participant attended a secure room at the university to have the orthosis fitted, and base line measures completed. The participant wore the orthosis in their standard day to day life, and were contacted at a convenient time by phone to collect outcome measures.
The participant were given a daily diary to write down any occasions that they removed the orthosis in the 24 hour wear period, and for what reason, they then read this to the second investigator when contacted by phone.
Intervention code [1] 316973 0
Treatment: Devices
Comparator / control treatment
Cross over design: Participants were exposed to both the traditional orthosis (thermoplastic) and the new intervention, 3D printed orthosis.
Control group
Active

Outcomes
Primary outcome [1] 323011 0
Canadian Occupational Performance Measure (COPM)
Timepoint [1] 323011 0
after 24 hour wear period of each orthosis
Secondary outcome [1] 380516 0
Grip strength of the hand using a Jamar Dynam0meter, handle position 2, three attempts taken and the average strength recorded.
Timepoint [1] 380516 0
at baseline with each orthosis on situ.
Secondary outcome [2] 380867 0
Tip to tip strength, using pinch gauge. Tip of index finger and tip of thumb, three attempts taken and average.
Timepoint [2] 380867 0
At baseline with each orthosis in situ.
Secondary outcome [3] 380868 0
Range of motion (ROM) of the PIPJ. A 15cm plastic gonimoter used to measure full extension and flexion of the PIPJ of the finger.
Timepoint [3] 380868 0
AT base line with orthosis in situ.

Eligibility
Key inclusion criteria
Over 18 years of age, a staff member or student from the Occupational Therapy course at an Australian University and were able to provide informed consent, no current (acute) hand injury.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to wear a finger orthosis for a total of 48 hours or had a current upper limb injury or condition, or were unable to read or understand English

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)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Online randomisation tool.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Participants provided a washout period of 24 hours between wearing each orthosis.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data was tested for normal distribution using The Shapiro-Wilk test (Field, 2013). Descriptive statistics, Paired t-tests for parametric data (Taylor, 2017) and Wilcoxon signed-rank test for non-parametric data (Taylor, 2017) were used to analyse differences between the two orthoses in hand function data, performance and satisfaction components of the COPM, as well as results from the Client Satisfaction Questionnaire. Qualitative data gathered from the COPM and Client Satisfaction Questionnaire were analysed using conceptual content analysis to enrich quantitative findings (Schreier, 2012).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/06/2019
Date of last participant enrolment
Anticipated
Actual
6/09/2019
Date of last data collection
Anticipated
Actual
20/09/2019
Sample size
Target
15
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 29479 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 305066 0
University
Name [1] 305066 0
Deakin University
Country [1] 305066 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
1 Gherighap Street, Geelong, Victoria, Australia, 3220
Country
Australia
Secondary sponsor category [1] 305433 0
None
Name [1] 305433 0
Address [1] 305433 0
Country [1] 305433 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305454 0
Deakin University, Faculty of Health Human Ethics Advisory Group
Ethics committee address [1] 305454 0
Ethics committee country [1] 305454 0
Australia
Date submitted for ethics approval [1] 305454 0
Approval date [1] 305454 0
27/06/2019
Ethics approval number [1] 305454 0
HEAG-H 58_2019

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

Contacts
Principal investigator
Name 100438 0
Mr Pearse Patrick Andrew Fay
Address 100438 0
Deakin University 1 Gherighap Street, Geelong, Victoria, 3220
Country 100438 0
Australia
Phone 100438 0
+61 352278322
Fax 100438 0
Email 100438 0
[email protected]
Contact person for public queries
Name 100439 0
Pearse Patrick Andrew Fay
Address 100439 0
Deakin University 1 Gherighap Street, Geelong, Victoria 3220
Country 100439 0
Australia
Phone 100439 0
+61 352278322
Fax 100439 0
Email 100439 0
[email protected]
Contact person for scientific queries
Name 100440 0
Pearse Patrick Andrew Fay
Address 100440 0
Deakin University 1 Gherighap Street, Geelong, Victoria 3220
Country 100440 0
Australia
Phone 100440 0
+61 352278322
Fax 100440 0
Email 100440 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Publicly available upon request

Conditions for requesting access:
• -

What individual participant data might be shared?
• Raw data of results is available upon request.

What types of analyses could be done with individual participant data?
• Viewing of raw data for evidence of statistical analysis

When can requests for individual participant data be made (start and end dates)?
From:
October 2019

To:
No end date

Where can requests to access individual participant data be made, or data be obtained directly?
• Data can be requested from the principal investigator via email request, [email protected].

Are there extra considerations when requesting access to individual participant data?
No


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.