Trial Review

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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
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?
Scientific title
Can a knee sleeve influence clinical outcomes and movement patterns in participants following ACL reconstruction?
Secondary ID [1] 295208 0
None
Universal Trial Number (UTN)
U1111-1212-3821
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior cruciate ligament rupture and reconstruction 308347 0
Condition category
Condition code
Physical Medicine / Rehabilitation 307348 307348 0 0
Physiotherapy
Musculoskeletal 307485 307485 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 301545 0
Treatment: Devices
Comparator / control treatment
The control group will receive no knee sleeve.
Control group
Active

Outcomes
Primary outcome [1] 306460 0
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).
Timepoint [1] 306460 0
While wearing the sleeve (sleeve condition) and without wearing the sleeve (control condition) during the first laboratory session (Baseline)
Primary outcome [2] 306461 0
Part 2 (RCT): International Knee Documentation Committee Subjective Knee Form (IKDC)
Timepoint [2] 306461 0
Baseline and at 6-week follow-up.
Secondary outcome [1] 348130 0
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).
Timepoint [1] 348130 0
(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)
Secondary outcome [2] 348131 0
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.
Timepoint [2] 348131 0
(1) Baseline, and (2) Follow-up, after wearing the knee sleeve for 6 weeks (Follow-up will be 6 weeks after Baseline)
Secondary outcome [3] 348132 0
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.
Timepoint [3] 348132 0
(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)

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).]
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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).

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)
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).

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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
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.
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/07/2018
Actual
Date of last participant enrolment
Anticipated
14/12/2018
Actual
Date of last data collection
Anticipated
31/01/2019
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment outside Australia
Country [1] 10563 0
New Zealand
State/province [1] 10563 0
Otago

Funding & Sponsors
Funding source category [1] 299793 0
Commercial sector/Industry
Name [1] 299793 0
Bauerfeind AG
Country [1] 299793 0
Germany
Primary sponsor type
Individual
Name
Dr Gisela Sole
Address
Center of Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
Box 56
Dunedin
9054
Country
New Zealand
Secondary sponsor category [1] 299142 0
Individual
Name [1] 299142 0
Associate Prof Niels Hammer
Address [1] 299142 0
Department of Anatomy
University of Otago
Box 56
Dunedin
9054
Country [1] 299142 0
New Zealand
Secondary sponsor category [2] 299144 0
Individual
Name [2] 299144 0
Dr Peter Lamb
Address [2] 299144 0
School of Physical Education and Exercise Sciences
University of Otago
Box 56
Dunedin
9054
Country [2] 299144 0
New Zealand
Secondary sponsor category [3] 299145 0
Individual
Name [3] 299145 0
Mr Andrew Gray
Address [3] 299145 0
Biostatistics Unit
Dunedin School of Medicine
Box 56
University of Otago
Dunedin
9054
Country [3] 299145 0
New Zealand
Other collaborator category [1] 280183 0
Individual
Name [1] 280183 0
Kyoto University
Address [1] 280183 0
Faculty of Medicine
Kyoto University
53 Kawahara-cho
Shogoin
Sakyo-ku
Kyoto 606-8501
Country [1] 280183 0
Japan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300679 0
Health and Disability Ethics Committee
Ethics committee address [1] 300679 0
Ministry of Health
133 Molesworth St
PO Box 5013
Wellington
6011
Ethics committee country [1] 300679 0
New Zealand
Date submitted for ethics approval [1] 300679 0
21/05/2018
Approval date [1] 300679 0
05/06/2018
Ethics approval number [1] 300679 0
18/CEN/94

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84446 0
Dr Gisela Sole
Address 84446 0
Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
Box 56
Dunedin
9054
Country 84446 0
New Zealand
Phone 84446 0
+64 3 4797936
Fax 84446 0
+64 3 4798414
Email 84446 0
gisela.sole@otago.ac.nz
Contact person for public queries
Name 84447 0
Dr Gisela Sole
Address 84447 0
Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
Box 56
Dunedin
9054
Country 84447 0
New Zealand
Phone 84447 0
+64 3 4797936
Fax 84447 0
+64 3 4798414
Email 84447 0
gisela.sole@otago.ac.nz
Contact person for scientific queries
Name 84448 0
Dr Gisela Sole
Address 84448 0
Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
Box 56
Dunedin
9054
Country 84448 0
New Zealand
Phone 84448 0
+64 3 4797936
Fax 84448 0
+64 3 4798414
Email 84448 0
gisela.sole@otago.ac.nz

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No Supporting Document Provided
Results publications and other study-related documents

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