Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000706976
Ethics application status
Approved
Date submitted
27/05/2020
Date registered
29/06/2020
Date last updated
2/11/2021
Date data sharing statement initially provided
29/06/2020
Date results provided
2/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of wrist movement during purposeful activities and wrist exercises after surgery for a wrist fracture
Scientific title
Evaluation of wrist motor performance outcomes during purposeful activities vs. standard wrist exercises after surgical treatment of a distal radius fracture: a randomised crossover trial.
Secondary ID [1] 301379 0
None
Universal Trial Number (UTN)
U1111-1247-0919
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical treatment of distal radius fracture 317630 0
Condition category
Condition code
Physical Medicine / Rehabilitation 315713 315713 0 0
Occupational therapy
Injuries and Accidents 315725 315725 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will employ a crossover study design where participants will participate in two conditions in random order during a single session on the same day. The sessions will be supervised by the primary researcher who is a NZ registered occupational therapist and hand therapist:
• Purposeful activity (PA): 10-minute performance of a self-selected activity
• Active exercise (AE): 10-minute performance of a set of standard wrist and forearm exercises
Participants will have a 60-minute rest period between conditions. The sessions will be supervised by the primary researcher who is a NZ registered occupational therapist and hand therapist.

Purposeful activity (PA)
Participants will perform a 10-minute session of a purposeful activity. The activity will be chosen by the participant from a range of daily activities that are routinely performed between weeks four and eight following surgery.
Criteria for activity
• Light daily activity
• Able to be graded up or down with respect to challenge
• Take at least ten minutes to perform
• Requires repeated movements of the hand, wrist and forearm to perform
• Does not involve immersion in water
• Defined according to American Occupational Therapy Association as an activity or occupation with purpose, utility or meaning

Examples of such activities include: preparing and consuming a hot drink, preparing a light snack, playing a board game, general household tidying, hanging out laundry, pet care activity, craft, art or light workshop activity

Prior to the performance of each condition, participants will be given the same instructions: to perform as much of the activity or set of exercises as desired; to move the wrist as much as possible during the 10 minutes; to put in as much effort as tolerated without causing pain or discomfort; to take a break or stop at any time if they wish to do so.

There will be no coaching during the performance of either condition.
Intervention code [1] 317682 0
Rehabilitation
Comparator / control treatment
Active exercise (AE)
Participants will perform a standardised active range of movement wrist exercise programme for a 10-minute period of time. The standard exercise programme was developed from the primary author's hand therapy clinic and published exercise programmes for this population.

The exercises to be performed are: one set of 10-15 repetitions of composite finger flexion and extension, wrist flexion and extension, wrist radial and ulna deviation, forearm supination and pronation and thumb flexion and extension

Prior to the performance of each condition, participants will be given the same instructions: to perform as much of the activity or set of exercises as desired; to move the wrist as much as possible during the 10 minutes; to put in as much effort as tolerated without causing pain or discomfort; to take a break or stop at any time if they wish to do so.

There will be no coaching during the performance of either condition.
Control group
Active

Outcomes
Primary outcome [1] 323928 0
Total volume of movement: calculated by rectifying the signal and determining the area under the curve for the sum of the wrist extension/flexion, radial/ulna deviation and pronation/supination arcs of motion. Total volume of movement is a measure of movement quantity.

A Biometrics twin-axis goniometer and torsiometer will be used to measure wrist and forearm movements. The validity of these devices has been previously determined. The devices have been widely used in wrist post-surgical populations and shown to be accurate and reliable for measurement of wrist range of movement, velocity and smoothness. All outcomes will be recorded by Biometrics Ltd analysis software version 11 . Data are sent via a wireless dongle to a computer.
Timepoint [1] 323928 0
The total volume of movement will be measured for both conditions i.e. for the 10-minute purposeful activity condition and for the 10-minute active exercise condition. The two 10-minute conditions will be performed on the same day.
Secondary outcome [1] 383354 0
Total movement duration during the 10 minutes session: calculated from the time when the wrist is not moving (velocity below 1°/s for a continuous period of at least 0.5 s) during the 10-minute recording session, via the electrogoniometry devices
Timepoint [1] 383354 0
Movement duration will be measured for both conditions i.e. for the 10-minute purposeful activity condition and for the 10-minute active exercise condition. The two 10-minute conditions will be performed on the same day.
Secondary outcome [2] 383355 0
Maximum end range for wrist extension: assessed by electrogoniometry
Timepoint [2] 383355 0
The maximum end range will be measured for both conditions i.e. for the 10-minute purposeful activity condition and for the 10-minute active exercise condition. The two 10-minute conditions will be performed on the same day.
Secondary outcome [3] 383356 0
Number of repetitions beyond 10° for wrist extension: assessed by electrogoniometry
Timepoint [3] 383356 0
The number of repetitions beyond 10° for wrist extension will be measured for both conditions i.e. for the 10-minute purposeful activity condition and for the 10-minute active exercise condition. The two 10-minute conditions will be performed on the same day.
Secondary outcome [4] 383357 0
Movement smoothness will be measured by acceleration data from the electrogoniometers. It will be calculated as the number of zero-crossings for the flexion/extension and pronation/supination arcs of motion. The zero-point is whenever acceleration changes from acceleration to deceleration and back again. It shows the number of times that the wrist slows down or speeds up during movement.
Timepoint [4] 383357 0
Movement smoothness will be measured for both conditions i.e. for the 10-minute purposeful activity condition and for the 10-minute active exercise condition. The two 10-minute conditions will be performed on the same day.
Secondary outcome [5] 383712 0
Maximum end range for supination: assessed by electrogoniometry
Timepoint [5] 383712 0
Maximum end range for supination will be measured for both conditions i.e. for the 10-minute purposeful activity condition and for the 10-minute active exercise condition. The two 10-minute conditions will be performed on the same day.
Secondary outcome [6] 383713 0
Maximum end range for ulnar deviation: assessed by electrogoniometry
Timepoint [6] 383713 0
Maximum end range for ulnar deviation will be measured for both conditions i.e. for the 10-minute purposeful activity condition and for the 10-minute active exercise condition. The two 10-minute conditions will be performed on the same day.
Secondary outcome [7] 383714 0
Number of repetitions beyond 10° for ulnar deviation: assessed by electrogoniometry
Timepoint [7] 383714 0
The number of repetitions beyond 10° for ulnar deviation will be measured for both conditions i.e. for the 10-minute purposeful activity condition and for the 10-minute active exercise condition. The two 10-minute conditions will be performed on the same day.
Secondary outcome [8] 383715 0
Number of repetitions beyond 10° for supination: assessed by electrogoniometry
Timepoint [8] 383715 0
The number of repetitions beyond 10° for supination will be measured for both conditions i.e. for the 10-minute purposeful activity condition and for the 10-minute active exercise condition. The two 10-minute conditions will be performed on the same day.

Eligibility
Key inclusion criteria
• Aged over 18 years
• Less than four weeks postoperative
• Stable fixation, deemed by surgeon to be suitable for mobilisation
• Conversational English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Any condition or injury that significantly affects normal use of the operated e.g. severe arthritis, stroke
• Concomitant fracture of another bone (except ulna styloid fracture)
• Concomitant surgical repair of tendon, muscle or nerve

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)
By centralised randomisation using a computerised program
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization will be balanced across periods (conditions one and two) and sequences (PA:AE and AE:PA).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Means and standard deviations, and minimum and maximum values will be reported for each motor performance variable between the conditions. Data will be analysed according to a linear mixed model. Model evaluation will be conducted using Akaike Information Criterion adjusted for small samples (AICs).
The carry over effects will be tested and left in the statistical model if significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2020
Actual
16/11/2020
Date of last participant enrolment
Anticipated
30/06/2021
Actual
7/06/2021
Date of last data collection
Anticipated
30/06/2021
Actual
21/06/2021
Sample size
Target
35
Accrual to date
Final
35
Recruitment outside Australia
Country [1] 22582 0
New Zealand
State/province [1] 22582 0

Funding & Sponsors
Funding source category [1] 305817 0
Government body
Name [1] 305817 0
Counties Manukau Health Research and Evaluation Office
Country [1] 305817 0
New Zealand
Funding source category [2] 305829 0
Charities/Societies/Foundations
Name [2] 305829 0
Occupational Therapy New Zealand - Whakaora Ngangahau Aotearoa
Country [2] 305829 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Auckland University of Technology (AUT)
Private Bag 92006
Auckland 1142 , New Zealand
Country
New Zealand
Secondary sponsor category [1] 306272 0
None
Name [1] 306272 0
Address [1] 306272 0
Country [1] 306272 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306087 0
Northern A Health and Disability Ethics Committees
Ethics committee address [1] 306087 0
Ethics committee country [1] 306087 0
New Zealand
Date submitted for ethics approval [1] 306087 0
22/02/2020
Approval date [1] 306087 0
18/05/2020
Ethics approval number [1] 306087 0
20/NTA/28

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

Contacts
Principal investigator
Name 102654 0
Ms Julie M Collis
Address 102654 0
Faculty of Health and Environmental Sciences
Auckland University of Technology
North Campus
90 Akoranga Drive
Northcote, Auckland 0627
Country 102654 0
New Zealand
Phone 102654 0
+64 9 921 9999
Fax 102654 0
Email 102654 0
[email protected]
Contact person for public queries
Name 102655 0
Julie M Collis
Address 102655 0
Faculty of Health and Environmental Sciences
Auckland University of Technology
North Campus
90 Akoranga Drive
Northcote, Auckland 0627
Country 102655 0
New Zealand
Phone 102655 0
+6499219999
Fax 102655 0
Email 102655 0
[email protected]
Contact person for scientific queries
Name 102656 0
Julie M Collis
Address 102656 0
Faculty of Health and Environmental Sciences
Auckland University of Technology
North Campus
90 Akoranga Drive
Northcote, Auckland 0627
Country 102656 0
New Zealand
Phone 102656 0
+6499219999
Fax 102656 0
Email 102656 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Raw data of motor performance outcomes will be available by request
When will data be available (start and end dates)?
Following the publication of results - no end date
Available to whom?
Case-by-case at the discretion of the principal researcher or primary sponsor
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
From the principal researcher or primary sponsor by email contact: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8094Other  [email protected] Intervention description



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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