Trial Review

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
ACTRN12615001348549p
Ethics application status
Not yet submitted
Date submitted
30/11/2015
Date registered
10/12/2015
Date last updated
10/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Can ankle dorsiflexion stretching change the landing biomechanics of lower limbs?
Scientific title
The effect of calf stretching on landing biomechanics related to ACL injury risk factors in young adults with limited ankle dorsiflexion.
Secondary ID [1] 287976 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy college students without orthopedic diseases and injuries of the lower limb and with limited ankle dorsiflexion. 296847 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297075 297075 0 0
Physiotherapy
Musculoskeletal 297174 297174 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this study is to analyze the biomechanics of landing before and after calf stretching for healthy athletes with limited ankle dorsiflexion. Participants will be divided into two groups; intervention (calf stretching) and control (arm stretching). The training program will involve 30 sessions consisting of a total of 10 minutes static stretching performed five times a week for 6 weeks. The program will be demonstrated by a physiotherapist at the beginning of the trial and a printout with the exercises will be provided to participants so that they can perfrom at home. The calf muscles of both legs will be stretched in four different positions. Each stretch will last 30 s for each position with a rest period of 30 s between stretches. Each stretch will be performed at the maximum dorsiflexion tolerated by the subjects. The following exercises will be used: (1) standing calf stretch, (2) standing calf stretch with foot on wall, (3) long sitting calf stretch, (4) standing calf stretch on step. A daily exercise check list will be used to monitor compliance.
Intervention code [1] 293310 0
Prevention
Comparator / control treatment
The control group will follow a stretching program of identical frequency and duration as the intervention group. The following exercises will be used: (1) Wall Stretch (biceps), (2) Hand Down Spine (triceps), (3) Elbows Back (pectoralis) (4) Shoulder cross (Deltoid muscles).
Control group
Placebo

Outcomes
Primary outcome [1] 296704 0
Primary outcome 1: Compare the change of the ankle dorsiflexion range of motion in control group and intervention group. Data will be collected maximal ankle dorsiflexion range of motion at weight-bearing. The joint angle of the ankle dorsiflexion will be measured using a smart phone application. This method achieved high reliability, with an ICC of 0.97.
Timepoint [1] 296704 0
Before and after 6-weeks intervention.
Primary outcome [2] 296729 0
Primary outcome 2: Data will be collected ankle, knee, hip joint range of motion, valgus angle (knee joint), maximum ground reaction force during drop vertical jump (DVJ) task as a sagittal plane movement. All subjects perform DVJ on a force plate. Three-dimensional whole body kinematics will record using 17 reflective markers placed on anatomical landmarks on the trunk, pelvis and the right leg via self-adhesive, double-sided tape. Marker trajectories will record with a 14-camera motion analysis system at a sampling frequency of 200 Hz.
Timepoint [2] 296729 0
The participants will perform drop vertical jump task before and after 6-weeks intervention.
Primary outcome [3] 296730 0
Primary outcome 3: Data will be collected ankle, knee, hip joint range of motion, valgus angle (knee joint), during lateral reactive jump (LRJ) task as a horizontal plane movement. Three-dimensional whole body kinematics will record using 17 reflective markers placed on anatomical landmarks on the trunk, pelvis and the right leg via self-adhesive, double-sided tape. Marker trajectories will record with a 14-camera motion analysis system at a sampling frequency of 200 Hz.
Timepoint [3] 296730 0
The participants will perform maximal LRJ task before and after 6-weeks intervention.
Secondary outcome [1] 319142 0
None
Timepoint [1] 319142 0
None

Eligibility
Key inclusion criteria
A. Participant is willing and able to give informed consent for participation in the study.
B. Male or Female, aged 20 to 35 years old.
C. Judged with limited ankle dorsiflexion: We will screen 100 healthy college students without orthopedic diseases and injuries of the lower limb and enroll the 30 participants with the most limited ankle dorsiflexionas determined by an inclinometer that mesures standing ankle dorsiflexion.
D. Participants able to perform physical activity such as jump test task.
Minimum age
20 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
A. Pregnancy during the course of the study.
B. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.
C. Participants are not able to perform the tasks and present other condition as pain of the knee joint, presence of neurological diseases, or inflammatory processes.
D. Participants who received oral steroids, steroid injection, opiate treatment, acupuncture or physiotherapy during the last 6 months.

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)
Thirty opaque, sealed envelopes will prepare in advance.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Thirty opaque, sealed envelopes will prepare in advance, containing cards with the name of the study group, of which 15 will for the control group and 15 for the intervention group.
All sealed envelopes will thoroughly mix.
The examiner randomly picked up the consequent envelope and gave it to the physical therapist who perform the stretching.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The intended sample size with a justification (where appropriate):
A priori power calculation was conducted using the G*Power statistical package. Calculations were based on the following parameters: 2-sided test, power of 0.80, alpha of .05, The effect size was 0.80. The number of subjects in each group, according to this calculation, was 15.
Statistical Analysis:
Statistical analysis will perform using SPSS Version 18 for Windows. The ten successful trials of each subject will averaged and served as the basis for the statistical analysis. We will performed with the Mann-Whitney U test for non-parametric variables due to the small number of subjects in each group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 292465 0
Self funded/Unfunded
Name [1] 292465 0
Country [1] 292465 0
Primary sponsor type
Individual
Name
Mei Ganse
Address
Mei Ganse
Block S224 (Cumberland Campus)
The University of Sydney
75 East St- Lidcombe 2141
NSW- AUSTRALIA
Country
Australia
Secondary sponsor category [1] 291174 0
Individual
Name [1] 291174 0
Evangelos Pappas
Address [1] 291174 0
Room O153
Block O (Cumberland Campus)
The University of Sydney
75 East St- Lidcombe 2141
NSW- AUSTRALIA
Country [1] 291174 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 293940 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 293940 0
Research Integrity & Ethics Administration
THE UNIVERSITY OF SYDNEY
Level 2- Margaret Telfer Building (K07)
The University of Sydney - NSW - 2006
Ethics committee country [1] 293940 0
Australia
Date submitted for ethics approval [1] 293940 0
19/01/2016
Approval date [1] 293940 0
Ethics approval number [1] 293940 0

Summary
Brief summary
The injury of the anterior cruciate ligament (ACL) is a typical injury of the knee joint that occurs during sports. According to recent studies, ACL injury mechanisms are multifactorial, resulting from the interplay of various factors. One potential injury risk factor of the ACL is limited ankle dorsiflexion. Dorsiflexion range of motion may alter lower-extremity landing mechanics in a manner, which predisposes athletes to injury. Our purpose is to clarify the effect of stretching by evaluating landing task biomechanics related to ACL injury before and after ankle dorsiflexion stretching.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61738 0
Dr Mei Ganse
Address 61738 0
Block S224 (Cumberland Campus)
The University of Sydney
75 East St- Lidcombe 2141
NSW- AUSTRALIA
Country 61738 0
Australia
Phone 61738 0
+61 423 243 605
Fax 61738 0
Email 61738 0
[email protected]
Contact person for public queries
Name 61739 0
A/Prof Evangelos Pappas
Address 61739 0
Room O153
Block O (Cumberland Campus)
The University of Sydney
75 East St- Lidcombe 2141
NSW- AUSTRALIA
Country 61739 0
Australia
Phone 61739 0
+61 2 9351 9188
Fax 61739 0
Email 61739 0
[email protected]
Contact person for scientific queries
Name 61740 0
Dr Mei Ganse
Address 61740 0
Block S224 (Cumberland Campus)
The University of Sydney
75 East St- Lidcombe 2141
NSW- AUSTRALIA
Country 61740 0
Australia
Phone 61740 0
+61 423 243 605
Fax 61740 0
Email 61740 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.