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Trial registered on ANZCTR


Registration number
ACTRN12615001330538
Ethics application status
Approved
Date submitted
20/11/2015
Date registered
4/12/2015
Date last updated
9/12/2019
Date data sharing statement initially provided
9/12/2019
Date results provided
9/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of mobilisation with movement in participants with distal radius fracture: A randomised controlled trial.
Scientific title
Effects of mobilisation with movement plus range of motion (ROM) exercises compared to ROM exercises alone on range of motion and function following a distal radius fracture: a randomised controlled trial
Secondary ID [1] 288070 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Distal radius fracture 296551 0
Condition category
Condition code
Musculoskeletal 296814 296814 0 0
Other muscular and skeletal disorders
Injuries and Accidents 296815 296815 0 0
Fractures
Physical Medicine / Rehabilitation 296816 296816 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive four standard physiotherapy consultations (approximately 20-30 minutes each) over four weeks. These sessions will commence within one week of removal of the plaster. A participant will receive two intervention sessions within the first week, session 3 will occur one week after session 2, session 4 will occur two weeks after session 3.
The treatment will be Mulligan mobilisation with movement (MWM) into the direction used to increase supination of the forearm and extension of the wrist. In addition to the therapist intervention, the participant will be taught at the first session to to do self-MWMs x 6 for forearm supination and wrist extension at home, twice a day (duration 6 minutes). They will also receive instructions by the physiotherapist to perform range of motion (ROM) exercises for the wrist (flexion, extension, pronation/supination arc), elbow (flexion/extension arc) and shoulder flexion x 5 for each exercise. The participant will be asked to do these ROM exercises twice a day (duration 4 minutes). Each home exercise session should last approximately 10 minutes; 6 minutes for the self-MWMs and 4 minutes for the ROM exercises. The home MWM and ROM sessions will continue for a duration of 4 weeks post first treatment session.
Participants will be encouraged to resume graded activities using the upper limb during activities of daily living. They will all be given a booklet with advice on fracture protection, swelling control, skin care.
Participants will have their attendance at the 4 Physiotherapy sessions logged in the Physiotherapist Notes - which will be supplied to the researchers after their 4th treatment session. The participants will keep a diary to log their adherence to the Self-MWMs and ROM exercises.
Intervention code [1] 293104 0
Treatment: Other
Intervention code [2] 293105 0
Rehabilitation
Comparator / control treatment
The control group will receive four standard physiotherapy consultations (approximately 20-30 minutes each) over four weeks. These sessions will commence within one week of removal of the plaster. A participant will receive two intervention sessions within the first week, session 3 will occur one week after session 2, session 4 will occur two weeks after session 3.
The control group will receive:
Session 1: instructions by a physiotherapist on how to perform ROM exercises for the wrist flexion, wrist extension, forearm pronation/supination, elbow flexion/extension, and shoulder flexion x 5 for each exercise. The participant will be asked to do these exercises twice a day. Each home ROM session should last approximately 4 minutes. The home ROM sessions will continue for a duration of 4 weeks post first treatment session.
Session 2: range of motion will be re-measured. The exercises will be checked.
Session 3: range of motion will be re-measured. The exercises will be checked.
Session 4: range of motion will be re-measured. The exercises will be checked
Participants will be encouraged to resume graded activities using the upper limb during activities of daily living. They will all be given a booklet with advice on fracture protection, swelling control, skin care.
Participants will have their attendance at the 4 Physiotherapy sessions logged in the Physiotherapist Notes - which will be supplied to the researchers after their 4th treatment session. The participants will keep a diary to log their adherence to the home ROM exercises.
Control group
Active

Outcomes
Primary outcome [1] 296412 0
Mean forearm active supination range of motion measured with a goniometer and following the standard administering procedures as outlined by the American Society of Hand Therapists and also using the Dr Goniometer smartphone app.
Timepoint [1] 296412 0
The primary time point for supination will be 4 weeks from baseline (straight after the interventions). The other time points for supination are base line and 12 week follow-up.
Secondary outcome [1] 318371 0
Mean forearm active pronation range of motion measured with a goniometer and following the standard administering procedures as outlined by the American Society of Hand Therapists and also using the Dr Goniometer app.
Timepoint [1] 318371 0
Baseline= 0 weeks (time of recruitment = about 6 weeks from time of injury)
Four weeks (immediately following intervention)
12 weeks (follow-up).
Secondary outcome [2] 318380 0
Mean isometric grip strength scores, measured in kilograms using a calibrated Jamar goniometer on setting 2 to ensure maximum grip strength with the participant seated and the elbow flexed to 90 degrees.
Timepoint [2] 318380 0
Baseline= 0 weeks (time of recruitment = about 6 weeks from time of injury)
Four weeks (immediately following intervention)
12 weeks (follow-up).
Secondary outcome [3] 318381 0
Functional test: ability to pour a cup of water into another cup using pronation and backwards into a cup using supination.
Timepoint [3] 318381 0
Baseline= 0 weeks (time of recruitment = about 6 weeks from time of injury)
Four weeks (immediately following intervention)
12 weeks (follow-up)
Secondary outcome [4] 318382 0
Pain and function as assessed on the Patient Rated Wrist Evaluation questionnaire

The Patient Rated Wrist Evaluation questionnaire is a composite secondary outcome. The questionnaire includes a numerical rating scale (0-10) for pain and rating scales (0-10) for functional activities.
Timepoint [4] 318382 0
Baseline= 0 weeks (time of recruitment = about 6 weeks from time of injury)
Two weeks
Four weeks (immediately following intervention)
12 weeks (follow-up)
6 months
12 months
Secondary outcome [5] 318384 0
Global rating of change
Timepoint [5] 318384 0
Two weeks
Four weeks (immediately following intervention)
12 weeks (follow-up)
6 months
12 months
Secondary outcome [6] 318513 0
Mean score on the Quality of Life SF8 questionnaire
Timepoint [6] 318513 0
Baseline= 0 weeks (time of recruitment = about 6 weeks from time of injury)
Two weeks
Four weeks (immediately following intervention)
12 weeks (follow-up)
6 months
12 months
Secondary outcome [7] 318559 0
Mean score on the Quick-DASH questionnaire will be used to measure disability of the affected upper limb.
Timepoint [7] 318559 0
Baseline= 0 weeks (time of recruitment = about 6 weeks from time of injury)
Two weeks
Four weeks (immediately following intervention)
12 weeks (follow-up)
6 months
12 months
Secondary outcome [8] 318560 0
Adherence to home exercise program will be assessed using the home exercise diaries. Participants will have to tick if they completed the exercise session. To determine adherence rates the number of sessions they completed will be compared to number of sessions prescribed.
Timepoint [8] 318560 0
Diary will be kept by all participants for four weeks from Session 1 to record adherence to home exercise program.
Secondary outcome [9] 319231 0
Mean wrist active extension range of motion measured with a goniometer and following the standard administering procedures as outlined by the American Society of Hand Therapists and also using the Dr Goniometer app.
Timepoint [9] 319231 0
Baseline= 0 weeks (time of recruitment = about 6 weeks from time of injury)
Four weeks (immediately following intervention)
12 weeks (follow-up).
Secondary outcome [10] 319232 0
Mean wrist active flexion range of motion measured with a goniometer and following the standard administering procedures as outlined by the American Society of Hand Therapists and also using the Dr Goniometer app.
Timepoint [10] 319232 0
Baseline= 0 weeks (time of recruitment = about 6 weeks from time of injury)
Four weeks (immediately following intervention)
12 weeks (follow-up).

Eligibility
Key inclusion criteria
Participants will be people who have suffered a fracture to the distal radius that has been treated non-surgically with a plaster cast.
They will be required to be aged over 18 years of age.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Surgical management of the distal radius fracture such as external fixation or open reduction with internal fixation
Previous wrist fracture on the affected side within last 20 years
Concurrent ipsilateral upper limb fracture
A condition such as pre-existing inflammatory joint condition that might raise the risk of injury with manual therapy treatment.
Signs and symptoms of complex regional pain syndrome
Inability to understand written or spoken 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)
Potential participants will be referred by medical practitioners, outpatient clinics, hand surgeons, Orthopaedic surgeons, hand units, and physiotherapists. They may also be recruited via a press release or advertisement such as on Facebook or Twitter. After a potential participant is referred to the study or makes contact to say they would like some information about the study, a researcher will explain the details of the study and determine if they meet the inclusion criteria. They will be given a participant information statement and taken through the consenting process.
A statistician (not aware of participant details or involved in participant recruitment, assessment or treatment) will use a computer generated mixed random allocation sequence to provide a randomisation table to advise of participant allocation to either the intervention or control group. This will be placed in sealed opaque envelopes to be used by the researchers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sealed opaque envelope will have a computer generated random number inside. The simple randomisation will be performed using a randomisation table created by computer software (i.e. computerised sequence generation). Participants will be stratified for type of fracture: if it is intra-articular or extra-articular.
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
Sample size
Calculations to estimate the sample size were based on a difference between groups that would be clinically significant for the main outcome measure, supination ROM, supported by the results of previous research. This was estimated by a biostatisticians from the Australian Catholic University using other studies that used supination ROM as an outcome measure (Challis et al 2007; Kay et al. 2008). Thirty-three participants in each group are required based on a change of 14 degrees in supination and a standard deviation of 20 with a power of 80% and a 5% confidence interval. For a moderate effect size of 0.7 we need to have 33 in each group. A linear mixed model will be used.

Statistical methods
Statistical analyses will be conducted using the SPSS (SPSS Inc., Chicargo, IL, USA) statistical package. It is proposed that as the response variables should have a normal distribution, parametric statistics including repeated measures analysis of variance (ANOVA) will be used. Nominal and interval data will be analysed using chi-square test and independent samples t-test. Biostatisticians from the Australian Catholic University will help with the statistical analyses. An intention-to-treat analysis will be performed. An alpha level of p<0.05 will be regarded as statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/05/2016
Actual
17/05/2016
Date of last participant enrolment
Anticipated
19/02/2018
Actual
13/12/2017
Date of last data collection
Anticipated
Actual
12/12/2018
Sample size
Target
66
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 292310 0
Other
Name [1] 292310 0
Mulligan Concept Teachers Association
Country [1] 292310 0
United States of America
Primary sponsor type
University
Name
Australian Catholic University
Address
40 Edward St
North Sydney
NSW 2060
Australia
Country
Australia
Secondary sponsor category [1] 290990 0
University
Name [1] 290990 0
The University of Queensland
Address [1] 290990 0
St Lucia
Brisbane
QLD 4072
Australia
Country [1] 290990 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293783 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 293783 0
Ethics committee country [1] 293783 0
Australia
Date submitted for ethics approval [1] 293783 0
19/11/2015
Approval date [1] 293783 0
22/02/2016
Ethics approval number [1] 293783 0
2015-314H

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

Contacts
Principal investigator
Name 61102 0
Dr Sue Reid
Address 61102 0
School of Physiotherapy
Faculty of Health Sciences
AUSTRALIAN CATHOLIC UNIVERSITY
Level 9, 33 Berry Street
North Sydney.
NSW. 2060
Australia


Country 61102 0
Australia
Phone 61102 0
+61 2 9739 2267
Fax 61102 0
+61 2 9739 2132
Email 61102 0
[email protected]
Contact person for public queries
Name 61103 0
Sue Reid
Address 61103 0
School of Physiotherapy
Faculty of Health Sciences
AUSTRALIAN CATHOLIC UNIVERSITY
Level 9, 33 Berry Street
North Sydney.
NSW. 2060
Country 61103 0
Australia
Phone 61103 0
+61 2 9739 2267
Fax 61103 0
+61 2 9739 2132
Email 61103 0
[email protected]
Contact person for scientific queries
Name 61104 0
Sue Reid
Address 61104 0
School of Physiotherapy
Faculty of Health Sciences
AUSTRALIAN CATHOLIC UNIVERSITY
Level 9, 33 Berry Street
North Sydney.
NSW. 2060
Country 61104 0
Australia
Phone 61104 0
+61 2 9739 2267
Fax 61104 0
+61 2 9739 2132
Email 61104 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?
The raw data will be available as an Excel file as part of the submission process. This de-identified data can be added as an electronic appendix to the paper,
When will data be available (start and end dates)?
The data is available now from 5th December 2019. End date 5th December 2024. (5 years).
Available to whom?
People researching on this topic, reviewers and Journal editors to increase the paper’s likelihood of acceptance
Available for what types of analyses?
to enable systematic review and met analysis if required for future research
How or where can data be obtained?
Email the lead author [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6085Study protocol  [email protected]
6086Informed consent form  [email protected]
6087Ethical approval  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.