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Trial registered on ANZCTR
Registration number
ACTRN12618001083280
Ethics application status
Approved
Date submitted
14/06/2018
Date registered
28/06/2018
Date last updated
9/01/2023
Date data sharing statement initially provided
2/06/2020
Date results provided
9/01/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Does wearing a knee sleeve lead to improved outcomes for patients with anterior cruciate ligament reconstruction?
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Scientific title
Can a knee sleeve influence clinical outcomes and movement patterns in participants following ACL reconstruction?
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Secondary ID [1]
295208
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None
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Universal Trial Number (UTN)
U1111-1212-3821
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anterior cruciate ligament rupture and reconstruction
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Condition category
Condition code
Physical Medicine / Rehabilitation
307348
307348
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0
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Physiotherapy
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Musculoskeletal
307485
307485
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This study will have two parts: (1) the immediate effects and (2) 6-week effects of wearing a knee sleeve on clinical outcomes.
For Part 1, all participants will undergo a cross-over study whereby they will be performing two sets of hops: one set not wearing a knee sleeve (control condition) and one set while wearing the knee sleeve on the injured side (Sleeve condition).
For Part 2, they will be randomised into two groups, with those allocated to the Intervention group being asked to wear a knee sleeve on the injured side for 6 weeks, and the Control group not being provided with such a sleeve.
Two different sets of hops will be used: (1) one maximum horizontal hop for distance, 3 repetitions for each side (uninjured versus injured sides); (2) Step down hop: participants will stand on a 30 cm box, step down onto the force plate, and hop forward on that leg at a distance of 60-70% of the uninjured horizontal hop distance. Five trials will be performed for each side. Three-dimensional movement analysis of the knee will be performed for the stance phase.
For Part 1, the cross-over trials, both hops (maximum horizontal hop, and step-down hop) will be performed with and without wearing a knee sleeve. Prior to each condition, the participant will be asked to rest for 10 minutes and then walk on a treadmill for 10 minutes. There will thus be an overall wash-up period of 20 minutes.
The intervention consists of use of the GenuTrain® knee sleeve (Bauerfeind AG, Zeulenroda, Germany). This is a flexible elastic/knitted sleeve to provide support to the knee without limiting range of motion in any direction. The GenuTrain® is a ‘CE’ certified medical device, ensuring that the device has been manufactured considering safety, performance and benefit, and on-going monitoring of the manufacturer and the device.
Manufacturer's guidelines will be used to individually size the sleeve. Participants will be asked to wear the sleeve on the injured side daily for at least 1 hour for six weeks. They will be required to complete a diary of the use of the knee sleeve, emailed to the primary investigator on a weekly basis.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
The control group will receive no knee sleeve.
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Control group
Active
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Outcomes
Primary outcome [1]
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Part 1 Cross-over trial: Horizontal jump distance (average of 3 repetitions) for the injured sides. The distance for the injured and the uninjured sides will be measured with a tape measure. Three repetitions will be performed for each side (without the sleeve), and with the sleeve (injured side), and the average will be calculated for each side and for the injured side sleeve condition.
For this part of the study, the primary outcome will be the ratio between the 'control condition' horizontal distance divided by the 'sleeve condition' horizontal distance (of the injured side).
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Assessment method [1]
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Timepoint [1]
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While wearing the sleeve (sleeve condition) and without wearing the sleeve (control condition) during the first laboratory session (Baseline)
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Primary outcome [2]
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Part 2 (RCT): International Knee Documentation Committee Subjective Knee Form (IKDC)
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Assessment method [2]
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Timepoint [2]
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Baseline and at 6-week follow-up.
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Secondary outcome [1]
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Part 2 (RCT): Maximal horizontal jump: the distance for the injured and the uninjured sides will be measured with a tape measure. Three repetitions will be performed for each side, and an average will be calculated for each side.
A lateral symmetry index will be calculated by dividing the average distance of the injured side by the uninjured side (without wearing the sleeve).
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Assessment method [1]
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Timepoint [1]
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(1) Baseline (with and without the sleeve) and (2) Follow-up (without the sleeve), after wearing the knee sleeve for 6 weeks (Follow-up will be 6 weeks after Baseline)
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Secondary outcome [2]
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Part 2 (RCT): Isokinetic concentric quadriceps muscle strength lateral asymmetry index: assessed for each side (injured and uninjured) with an isokinetic dynamometer (Biodex Medical Systems, Inc) using previously published procedures from our laboratory. The participant will be in a seated position and perform five reciprocal concentric contractions for the knee extensors (quadriceps) and flexors (hamstrings) at a slow speed (60°/s).
The peak torque will be determine for the injured and uninjured sides, and expressed as an asymmetric index: the peak torque of the injured side will be divided by the uninjured side.
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Assessment method [2]
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Timepoint [2]
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(1) Baseline, and (2) Follow-up, after wearing the knee sleeve for 6 weeks (Follow-up will be 6 weeks after Baseline)
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Secondary outcome [3]
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Part 1 (Cross-over study) and Part 2 (RCT): External knee moments of the ACL reconstructed knee, calculated from three-dimensional (3D) movement analysis during a step-down hop.
The motion analysis will be undertaken for the step-down hop with a 12-camera system (Motion Analysis Corporation, Santa Rosa, CA, USA) and Cortex 2.0 software, synchronized with a floor-mounted force plate (AMTI Inc., Newton, MA, USA). the kinematic (joint angles) and kinetic (moments) data will be processed with Visual 3-D (Motion Analysis Corporation, Santa Rosa, CA). Inverse dynamics will be used for calculating knee moments. An exploratory approach will be used by analysing the knee moment trajectory with Statistical Parametric Mapping.
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Assessment method [3]
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Timepoint [3]
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(1) Baseline (with and without the sleeve), and (2) Follow-up (without the sleeve), after wearing the knee sleeve for 6 weeks (Follow-up will be 6 weeks after Baseline)
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Eligibility
Key inclusion criteria
• Men and women (aged 18-40 inclusive) with an ACL reconstruction at least 6 months but less than 3 years (36 months) previously.
• We are specifically seeking individuals who have not yet reached full functional level. The functional level will be assessed with the International Knee Documentation Committee Subjective Knee Form (IKDC): participants must have achieved between 40 and 80/100. [Higher IKDC scores indicate better function. By including those between 40 and 80/100, those with very poor function (<40) are excluded, as well as those who have regained very good function (>80).]
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Minimum age
18
Years
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Maximum age
40
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Revision ACL reconstruction of the same knee, or a previous ACL reconstruction of the opposite knee;
• Pregnancy;
• Any other lower limb, pelvic or low back musculoskeletal injuries or disorders that needed health care over the past 6 months or are currently limiting their daily function, sports or occupational performance;
• Known systemic, neurological or cardiovascular disorders,
• International Knee Disability Classification (IKDC) score: total score less than 40 or greater than 80/100 (to exclude those with significant symptoms and thus should not be hopping; and those who have nearly recovered where a sleeve would clinically be less likely to add benefit); reporting a ‘moderately’, ‘very’ or ‘extremely’ swollen knee (Question 4); reporting their ‘highest level of activity’ to be only ‘light activities’ due to pain, swelling, or giving way.
• Body mass index (BMI) above 30 kg/m2 (i.e., the participants can be overweight but not obese).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be individually randomised twice (once for the acute phase and once for the 6-week study) with equal numbers in each group for both allocations. Allocation will be concealed with two sealed opaque envelopes, one for Part 1 (cross-over study), the other for Part 2 (RCT).
Part 1 Baseline assessment and laboratory cross-over trial: For groups for Part 1 (laboratory cross-over study), participants will be allocated to the following two groups:
Group 1 will be tested under the control condition (no sleeve) first, followed by the experimental condition (with the sleeve);
Group 2 will be tested under the experimental condition (with the sleeve), followed by the control condition (no sleeve).
Part 2 RCT and follow-up assessment: At the completion of the laboratory trial, the participants will be allocated again into two groups A and B, independently of their allocation in Part 1.
Group A participants will be provided with a sleeve to use for the following 6 weeks (intervention group);
Groups B participants will not be provided a sleeve (control group).
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each group will be stratified by sex to ensure similar numbers of men and women are in each group. The randomisation schedule will be computer-generated by the Research Assistant.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Other
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Other design features
During the first visit to the laboratory, participants will undergo a cross-over trial (Part 1).
Part 2 of the study, namely the RCT, is a parallel assignment.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Sample size:
Part 1: Given the test-retest ICCs reported above, we have assumed a conservative correlation between repeated measures of 0.8 for Part 1. The sample size of 32 participants (all 32 participants receiving both conditions) will allow 80% power to detect a 0.33 SD differences between the sleeve and no-sleeve conditions using a two-sided test of means at the 0.05 level. This is between a small (0.2 SD) and moderate (0.5 SD) effect size.
For Part 2, allowing for a slightly weaker correlation between repeated measures of 0.7 and up to 10% attrition, this would allow 80% power to detect differences in changes between the sleeve-wearing and control groups of 0.86 SDs using a two-sided test of means at the 0.05 level, slightly larger than a large effect size (0.8 SD).
Data analysis
Part 1:
Linear mixed models including a sequence term will be used to compare sleeve and no-sleeve conditions if model assumptions are satisfied. This will provide an estimate of the differences in outcomes between the (1) control and (2) sleeve conditions for the horizontal jump test (lateral symmetry index). 95% confidence intervals and p-values will guide interpretation of these differences. If model assumptions are not satisfied, natural logarithm transformations will be investigated, producing ratio differences, and should this still not satisfy model assumptions, mixed quantile regression models will be used instead.
Three-dimensional motion analysis data during the step-down hop (control versus sleeve conditions) will be analysed using exploratory coordination network analysis, followed by time-based statistical analysis, eg Statistical Parametric Mapping. If significant differences are found for either of those analyses, discrete variables will be extracted (such as peak trunk flexion, knee excursion range, and peak external flexion moments). The same modelling strategy as described above will then be used to determine whether significant between-condition differences exist.
Part 2:
Linear mixed models (with a group x time interaction) will be used to determine whether differences exist in changes from baseline to follow-up, post six-week sleeve use between the control and the intervention groups for IKDC, horizontal jump test (lateral symmetry index), and muscle strength. Model assumptions will be examined and if necessary transformations will be used to achieve their satisfaction. If model assumptions remain unsatisfied, linear quantile regression modelling medians will be used instead.
Three-dimensional motion data during the step-down hop (control versus sleeve conditions) will be analysed using exploratory coordination network analysis, followed by time-based statistical analysis, eg Statistical Parametric Mapping. If significant differences are found for either of those analyses, discrete variables will be extracted (such as peak trunk flexion, knee excursion range, and peak external flexion moments). The same modelling strategy as described above will then be used to determine whether significant between-group differences in changes exist.
The primary analyses for Part 2 will be for between-group differences between the sleeve and the control (no sleeve) testing conditions.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
23/07/2018
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Actual
30/08/2018
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Date of last participant enrolment
Anticipated
18/09/2020
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Actual
18/09/2020
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Date of last data collection
Anticipated
30/10/2020
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Actual
30/10/2020
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Sample size
Target
32
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Accrual to date
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Final
34
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Otago
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Funding & Sponsors
Funding source category [1]
299793
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Commercial sector/Industry
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Name [1]
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Bauerfeind AG
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Address [1]
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Triebeser Strasse 16
07937 Zeulenroda-Triebes
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Country [1]
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Germany
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Primary sponsor type
Individual
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Name
Dr Gisela Sole
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Address
Center of Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
Box 56
Dunedin
9054
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Country
New Zealand
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Secondary sponsor category [1]
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Individual
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Name [1]
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Associate Prof Niels Hammer
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Address [1]
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Department of Anatomy
University of Otago
Box 56
Dunedin
9054
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Country [1]
299142
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New Zealand
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Secondary sponsor category [2]
299144
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Individual
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Name [2]
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Dr Peter Lamb
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Address [2]
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School of Physical Education and Exercise Sciences
University of Otago
Box 56
Dunedin
9054
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Country [2]
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New Zealand
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Secondary sponsor category [3]
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Individual
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Name [3]
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Mr Andrew Gray
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Address [3]
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Biostatistics Unit
Dunedin School of Medicine
Box 56
University of Otago
Dunedin
9054
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Country [3]
299145
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New Zealand
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Other collaborator category [1]
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Individual
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Name [1]
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Kyoto University
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Address [1]
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Faculty of Medicine
Kyoto University
53 Kawahara-cho
Shogoin
Sakyo-ku
Kyoto 606-8501
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Country [1]
280183
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Japan
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Health and Disability Ethics Committee
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Ethics committee address [1]
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Ministry of Health 133 Molesworth St PO Box 5013 Wellington 6011
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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21/05/2018
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Approval date [1]
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05/06/2018
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Ethics approval number [1]
300679
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18/CEN/94
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Summary
Brief summary
This study will explore whether wearing a knee sleeve following surgery for ruptures of the anterior cruciate ligament (of the knee) improves function (defined with a self-reported questionnaire), maximum hop distance, knee movement patterns during a hop, and thigh muscle strength . The hypothesis is that participants (following such surgery) who wear the sleeve at least one hour for six weeks will have greater improvement in function, hop distance, knee movement patterns and thigh muscle strength than a group of participants who do not wear the knee sleeve.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Gisela Sole
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Address
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Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
Box 56
Dunedin
9054
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Country
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New Zealand
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Phone
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+64 3 4797936
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Fax
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+64 3 4798414
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Email
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gisela.sole@otago.ac.nz
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Contact person for public queries
Name
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Gisela Sole
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Address
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Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
Box 56
Dunedin
9054
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Country
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New Zealand
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Phone
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+64 3 4797936
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Fax
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+64 3 4798414
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Email
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gisela.sole@otago.ac.nz
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Contact person for scientific queries
Name
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Gisela Sole
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Address
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Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
Box 56
Dunedin
9054
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Country
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New Zealand
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Phone
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+64 3 4797936
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Fax
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+64 3 4798414
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Email
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gisela.sole@otago.ac.nz
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified data of demographic data and outcome variables.
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When will data be available (start and end dates)?
Not defined yet.
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Available to whom?
Researchers with a proposal only
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Available for what types of analyses?
For any purpose, approved by an ethics committee.
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How or where can data be obtained?
The Primary Investigator: gisela.sole@otago.ac.nz
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Sole, G., Pataky, T., Hammer, N., & Lamb, P. (2022...
[
More Details
]
375347-(Uploaded-11-01-2024-13-52-21)-Journal results publication.pdf
Study results article
Yes
Sole G, Lamb P, Pataky T, Pathak A, Klima S, Navar...
[
More Details
]
375347-(Uploaded-11-01-2024-13-50-03)-Journal results publication.pdf
Study results article
Yes
Sole G, Pataky T, Hammer N, Lamb P (2022). Can a k...
[
More Details
]
375347-(Uploaded-11-01-2024-13-51-01)-Journal results publication.pdf
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Can a knee sleeve influence ground reaction forces and knee joint power during a stepdown hop in participants following anterior cruciate ligament reconstruction? A secondary analysis.
2022
https://dx.doi.org/10.1371/journal.pone.0272677
Embase
Immediate and six-week effects of wearing a knee sleeve following anterior cruciate ligament reconstruction on knee kinematics and kinetics: a cross-over laboratory and randomised clinical trial.
2022
https://dx.doi.org/10.1186/s12891-022-05488-2
N.B. These documents automatically identified may not have been verified by the study sponsor.
Download to PDF