Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616001308482
Ethics application status
Approved
Date submitted
16/08/2016
Date registered
19/09/2016
Date last updated
22/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving biomechanical risk factors for non-contact knee injury: the effect of kinesiotape and motor control retraining on postural stability and lower limb biomechanics of a single leg squat and single leg landing task in healthy females
Scientific title
Improving biomechanical risk factors for non-contact knee injury: the effect of kinesiotape and motor control retraining on postural stability and lower limb biomechanics of a single leg squat and single leg landing task in healthy females
Secondary ID [1] 289908 0
Nil
Universal Trial Number (UTN)
U1111-1186-2123
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-contact knee injury 299872 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299778 299778 0 0
Physiotherapy
Musculoskeletal 300153 300153 0 0
Other muscular and skeletal disorders
Injuries and Accidents 300154 300154 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be multiple interventions within this study, and it will be broken down into three separate three-way cross-over trials performed at the same site with different participants which will then be combined for data analysis. Note that for all trials, participants will be randomly allocated to one of 6 sequences (ABC, ACB, BAC, BCA, CAB, CBA) so that there are equal numbers in each sequence.

Sub Trial 1. Trunk Motor Retraining - Washout Period 1 Week
Control (C): No intervention performed
Intervention A: a single session of isolated trunk motor retraining, with the therapist guiding 5x 10 second contractions of transversus abdominis (with 10sec rest periods), with real time ultrasound used for visual feedback
Intervention B: a single session of global trunk motor retraining, with the therapist guiding a 5x 10 second plank on elbows and toes (with 10 sec rest periods) with verbal feedback from therapist re: correct exercise form

Sub Trial 2: Hip Motor Retraining - Washout Period 1 Week
Control (C): No intervention performed
Intervention A: a single session of isolated hip motor retraining, with the therapist guiding two separate sets of 5x 5 second contractions of gluteus minimus and quadratus femoris respectively (with 5 sec rest periods) - real time ultrasound used as visual feedback
Intervention B: a single session of global hip motor retraining, with the therapist guiding 5x 10 sec arabesques and 5x 10sec McConnell wall push (with 10sec rest periods) - verbal feedback from therapist re:correct exercise form

Sub Trial 3: Kinesiotaping - Washout Period 1 Week
Control (C): No intervention performed
Intervention A: application of kinesiotape to the ankle joint by the therapist with effects measured immediately after application, with the tape removed after the session is complete. Tape will be applied in a sling, from the anterior tibia, travelling medially and inferiorly to move underneath the arch of the foot, and back up to the anterior tibia via the lateral aspect of the foot and leg. This will be applied with 50% stretch
Intervention B: application of kinesiotape to the hip joint by the therapist with effects measured immediately after application, with the tape removed after the session is complete. Taping will be in a spiral external rotation pattern beginning from the lateral femoral condyle, crossing the thigh anteriorly, over the greater trochanter then posteriorly to the PSIS , applied with 50% stretch.

All interventions will be supervised by a qualified APA Sports Physiotherapist. Strategies to improve adherence are irrelevant as all exercises will be performed in a single session and monitored and guided by the researchers
Intervention code [1] 295590 0
Prevention
Comparator / control treatment
This study will be controlled by use of a crossover trial - the participants will act as their own control. Each participant will also undergo a control session where they complete a baseline and post-intervention assessment without receiving any intervention.
Control group
Active

Outcomes
Primary outcome [1] 299244 0
2D frontal plane measure of knee valgus (frontal plane projection angle) during a single leg squat and single leg jump measured by video capture and analysis of anatomical markers using Dartfish Biomechanical Analysis software
Timepoint [1] 299244 0
Immediately after intervention
Primary outcome [2] 299245 0
Centre of Pressure (COP) calculations from a force plate and accompanying software - COP velocity during a single leg squat and single leg jump.
Timepoint [2] 299245 0
Immediately after intervention
Secondary outcome [1] 326823 0
2D frontal plane lateral trunk flexion angle during a single leg squat and single leg jump measured by video capture and analysis of anatomical markers using Dartfish Biomechanical Analysis software
Timepoint [1] 326823 0
Immediately after intervention
Secondary outcome [2] 327742 0
2D sagittal plane hip flexion angle during a single leg squat and single leg jump measured by video capture and analysis of anatomical markers using Dartfish Biomechanical Analysis software
Timepoint [2] 327742 0
Immediately after intervention
Secondary outcome [3] 327754 0
2D sagittal plane knee flexion angle during a single leg jump measured by video capture and analysis of anatomical markers using Dartfish Biomechanical Analysis software
Timepoint [3] 327754 0
Immediately after intervention
Secondary outcome [4] 334028 0
Centre of Pressure (COP) calculations from a force plate and accompanying software - COP length during a single leg squat and single leg jump
Timepoint [4] 334028 0
Immediately After Intervention
Secondary outcome [5] 334029 0
Centre of Pressure (COP) calculations from a force plate and accompanying software - COP average radial displacement during a single leg squat and single leg jump.
Timepoint [5] 334029 0
Immediately After Intervention
Secondary outcome [6] 334030 0
Centre of Pressure (COP) calculations from a force plate and accompanying software - COP area of 95% ellipse during a single leg squat and single leg jump.
Timepoint [6] 334030 0
Immediately after intervention
Secondary outcome [7] 334031 0
Force Plate Data Output - Peak Vertical Force (as calculated by force plate software) during a single leg squat and single leg jump.
Timepoint [7] 334031 0
Immediately after intervention
Secondary outcome [8] 334032 0
Force Plate Data Output - Peak Posterior Shear Force (as calculated by force plate software) during a single leg squat and single leg jump.
Timepoint [8] 334032 0
Immediately after intervention

Eligibility
Key inclusion criteria
Female aged 18-35
Minimum age
18 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
6 Month history of lower limb, abdominal or spinal pathology injury or surgery, chronic ankle instability, any history of serious knee injury, vestibular or balance impairments, cognitive impairments, non-english speaking, severe cardiopulmonary, neuromuscular or integumentary disorders

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be assigned a numeric identifier, with each identifier being randomly allocated to one of 6 sequences via use of an online software (randomizer.org)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
ANOVA and a post-hoc least significant difference test will be used for data analysis. Note that the target number of participants was determined primarily by the likely maximum number of participants that will be able to be recruited.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/10/2016
Actual
6/03/2017
Date of last participant enrolment
Anticipated
6/03/2017
Actual
20/04/2017
Date of last data collection
Anticipated
5/05/2017
Actual
5/05/2017
Sample size
Target
100
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment postcode(s) [1] 14019 0
2640 - Thurgoona

Funding & Sponsors
Funding source category [1] 294276 0
University
Name [1] 294276 0
Charles Sturt University
Country [1] 294276 0
Australia
Primary sponsor type
University
Name
Charles Sturt University
Address
Charles Sturt University School of Community Health
Elizabeth Mitchell Drive
Thurgoona, NSW 2640
Country
Australia
Secondary sponsor category [1] 293111 0
None
Name [1] 293111 0
N/A
Address [1] 293111 0
N/A
Country [1] 293111 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295707 0
Charles Sturt University Human Research Ethics Commitee
Ethics committee address [1] 295707 0
School of Community Health
PO Box 789
ALBURY NSW 2640
Ethics committee country [1] 295707 0
Australia
Date submitted for ethics approval [1] 295707 0
12/08/2016
Approval date [1] 295707 0
15/09/2016
Ethics approval number [1] 295707 0
H16140

Summary
Brief summary
Non-contact knee injuries (especially those involving the ligaments of the knee) are prevalent in the female athlete population. The risk of knee injury has been largely correlated with several specific biomechanical patterns including knee valgus and lateral trunk flexion during dynamic tasks, as well as measures of postural control. The research team is interested in whether novel injury prevention strategies could help to reduce these risk factors during dynamic tasks (single leg squat and single leg landing). Specifically, we are interested to see if risk factors for knee injury can be reduced following one of the following three interventions.

1. contracting specific muscles of the trunk, known as trunk motor control retraining, for a few moments at a time over a 5 minute period prior to performing a single leg squat and single leg jump task that will be captured using a force plate and motion analysis software for examination of joint angles.
2. contracting specific muscles of the hip, known as hip motor control retraining, for a few moments at a time over a 5 minute period prior to performing a single leg squat and single leg jump task that will be captured using a force plate and motion analysis software for examination of joint angles.
3. application of a soft, flexible sports tape, called kinesio tape applied to joints of the lower limb prior to performing a single leg squat and single leg jump task that will be captured using a force plate and motion analysis software for examination of joint angles.

The research team is also interested in relationships between participant height, body composition, leg dominance, and biomechanics, which will be measured using image capture technology and a force plate. The intervention groups will consist of females aged between 18-35 because this is the population most considered 'high risk' for serious knee injury. The aim of the study is to investigate the effects of trunk motor control retraining, hip motor control retraining and application of kinesio tape on biomechanical risk factors for non-contact knee injury during a single leg squat and a single leg landing in female athletes. Participants will be asked to attend three data collection sessions, spread out over a minimum period of three weeks (in order to include for a washout period). The first session will include completion of a health and activity questionnaire and gathering of participant details, such as height and weight. In each of the three visits, participants will either undergo a control session OR trunk muscle retraining OR hip muscle retraining OR application of sports tape to the lower limb, with analysis of a single leg squat and a single leg landing via motion capture ( the sequence will be randomly allocated)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68178 0
Miss Sophie Dahlenburg
Address 68178 0
Charles Sturt University, Elizabeth Mitchell Drive
Room 422, Building 673 (Gordon Beavan Building)
PO Box 789
Thurgoona, NSW, 2640
Country 68178 0
Australia
Phone 68178 0
+61478689461
Fax 68178 0
Email 68178 0
[email protected]
Contact person for public queries
Name 68179 0
Sophie Dahlenburg
Address 68179 0
Charles Sturt University, Elizabeth Mitchell Drive
Room 422, Building 673 (Gordon Beavan Building)
PO Box 789
Thurgoona, NSW, 2640
Country 68179 0
Australia
Phone 68179 0
+61478689461
Fax 68179 0
Email 68179 0
[email protected]
Contact person for scientific queries
Name 68180 0
Sophie Dahlenburg
Address 68180 0
Charles Sturt University, Elizabeth Mitchell Drive
Room 422, Building 673 (Gordon Beavan Building)
PO Box 789
Thurgoona, NSW, 2640
Country 68180 0
Australia
Phone 68180 0
+61478689461
Fax 68180 0
Email 68180 0
[email protected]

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
No additional documents have been identified.