Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001428459
Ethics application status
Approved
Date submitted
11/10/2016
Date registered
13/10/2016
Date last updated
13/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The influence of sensory awareness training, additional motor practice and usual practice on scalpel skill learning in podiatry students.
Scientific title
A randomised controlled trial of sensory awareness training and additional motor practice for learning scalpel skills in a podiatry student population.
Secondary ID [1] 290301 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dexterity 300545 0
Psychological status (self-efficacy, anxiety, motivation) 300546 0
Condition category
Condition code
Public Health 300405 300405 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sensory awareness training - Participants randomised to the sensory awareness group were initially separated and provided sensory awareness training in the form of face-to-face Feldenkrais ATM (awareness through movement) for approximately 40 minutes. Feldenkrais method is an "..educational system that develops a functional awareness of the self in the environment" (Buchanan & Ulrich 2001). The practitioner verbally guides participants through a sequence of gentle movements based on functional activities such as reaching, and encourages attention of these. The initial training was delivered as a group by a trained Feldenkrais practitioner who is also a Neurophysiotherapist. The initial training was supplemented with audio recordings of two sessions, a 'sitting' session focussing on relaxation and awareness, and another lesson targeting the dominant hand. Each lesson goes for approximately 40 minutes. The audio recordings were provided via a CD and a download link, to allow downloading of the audio file over the internet if required.

(Additional) Motor Practice - Participants randomised to the additional Motor practice group were separated and instructed in methods for motor practice in the form of staged scalpel practice, including: holding a pen in the same manner as a scalpel and replicating usual movement either in free space or on paper, varying the applied pressure; using a scalpel on inanimate objects such as soap or oranges. The initial session was run by a podiatrist not involved in data collection. Subsequent sessions could be done by each participant in their own time, although a set time in which participants could access the student clinic for practice was also provided at one of the sites.

Participants from both groups were instructed to undertake training as regularly as they could, but at least three times per week. The timing of, and specific activity in which they were to engage (ie which lesson for the sensory awareness group, or which motor activity for the additional motor practice group), was not specified but left to the discretion and motivation of each participant. It was hoped this would improve compliance and reflect more real-life conditions.

Each participant from the two intervention groups were required to keep a small log book of the duration of each practice session undertaken and the chosen activity was completed. The training period was defined as being of at least two weeks duration, but needed to be continued until follow-up testing was undertaken.
Intervention code [1] 296106 0
Other interventions
Comparator / control treatment
The control group were not provided any additional training but learnt scalpel skills and undertook practice in line with common practice at the institution in which they studied.
Control group
Active

Outcomes
Primary outcome [1] 299849 0
Dexterity measured by change in performance on: Purdue Pegboard, Grooved Pegboard Test, Grip-Lift task.
Timepoint [1] 299849 0
At least two weeks post commencement of intervention.
Secondary outcome [1] 328306 0
Change in psychological status (Self-efficacy, motivation and anxiety) as measured with the Intrinsic Motivation Inventory (IMI)
Timepoint [1] 328306 0
At least two weeks post commencement of intervention

Eligibility
Key inclusion criteria
Second year podiatry students who were about to commence learning scalpel and other related manual skills.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Had previously used a scalpel
An occupation or hobby which required high levels of dexterity (ie a musician or chef)
On medication or had a condition which could affect hand function

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was undertaken using a computer-generated list by a person independent to the data collection process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation via an online sequence generator, stratified across data collection sites
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An apriori power calculation was determined based on the Purdue pegboard measures from a study with a related intervention. This was based on 80% power and an effect size of 0.75. Categorical values for each group (such as location, sex, handedness, musical instrument history and gaming history) were compared using a Chi Square analysis. Continuous variables (such as age, height and intervention duration) were compared using a generalised linear model univariate analysis of variance. Data were evaluated for distribution and transformed as necessary. Evaluation of the psychological measures from the IMI were evaluated using a repeated measures mixed model analysis with location included as a fixed effect to account for possible variation between the sites. The objective dexterity tests were compared for between group differences using repeated measures mixed model analysis. Age, sex, location, handedness and other demographic variables were either included or removed as fixed variables to determine the most appropriate model based on Bayesian Information Criterion (BIC) values. Significance was set at p < 0.05

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/02/2013
Date of last participant enrolment
Anticipated
Actual
20/03/2013
Date of last data collection
Anticipated
Actual
27/05/2013
Sample size
Target
87
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment postcode(s) [1] 14450 0
4059 - Kelvin Grove
Recruitment postcode(s) [2] 14449 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 294681 0
Other Collaborative groups
Name [1] 294681 0
Australian Podiatry Education Research Fund (APERF)
Country [1] 294681 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 293529 0
None
Name [1] 293529 0
Address [1] 293529 0
Country [1] 293529 0
Other collaborator category [1] 279263 0
University
Name [1] 279263 0
Queensland University of Technology
Address [1] 279263 0
Kelvin Grove Campus
Cnr Musk and Victoria Park Rd
Kelvin Grove QLD 4059
Country [1] 279263 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296107 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 296107 0
Ethics committee country [1] 296107 0
Australia
Date submitted for ethics approval [1] 296107 0
20/02/2012
Approval date [1] 296107 0
30/03/2012
Ethics approval number [1] 296107 0
0000027836

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1160 1160 0 0
/AnzctrAttachments/371628-consentform study three amended.pdf (Participant information/consent)
Attachments [2] 1161 1161 0 0
/AnzctrAttachments/371628-Information sheet study three.docx (Participant information/consent)
Attachments [3] 1162 1162 0 0
/AnzctrAttachments/371628-Ethics - approved.pdf (Ethics approval)

Contacts
Principal investigator
Name 69570 0
Dr Ryan Causby
Address 69570 0
C/- University of South Australia, School of Health Science
Level 8, Centenary Building
North Terrace,
Adelaide SA 5000
Country 69570 0
Australia
Phone 69570 0
+61 8 8302 1274
Fax 69570 0
Email 69570 0
Ryan.Causby@unisa.edu.au
Contact person for public queries
Name 69571 0
Ryan Causby
Address 69571 0
University of South Australia, School of Health Sciences
GPO Box 2471
Adelaide
SA 5001
Country 69571 0
Australia
Phone 69571 0
+61 8 8302 1274
Fax 69571 0
Email 69571 0
Ryan.Causby@unisa.edu.au
Contact person for scientific queries
Name 69572 0
Ryan Causby
Address 69572 0
University of South Australia, School of Health Sciences
GPO Box 2471
Adelaide
SA 5001
Country 69572 0
Australia
Phone 69572 0
+61 8 8302 1274
Fax 69572 0
Email 69572 0
Ryan.Causby@unisa.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseA randomised controlled trial of sensory awareness training and additional motor practice for learning scalpel skills in podiatry students.2016
N.B. These documents automatically identified may not have been verified by the study sponsor.