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
ACTRN12614000981628
Ethics application status
Approved
Date submitted
4/09/2014
Date registered
12/09/2014
Date last updated
12/09/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of talocrural mobilisation with movement on ankle dorsiflexion and knee valgus during squatting in individuals with a history of ankle sprains
Scientific title
The effect of talocrural mobilisation with movement on ankle dorsiflexion and knee valgus during squatting in individuals with a history of ankle sprains
Secondary ID [1] 285221 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Decreased dorsiflexion range of motion 292850 0
History of lateral ankle sprains 292939 0
Condition category
Condition code
Musculoskeletal 293149 293149 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 293150 293150 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The talocrural joint mobilisation with movement technique will be performed in a weight-bearing positions with the patient lunging forward on the leg being treated. A transfer belt will be positioned over the posterior distal tibia and fibula. An anterior glide will be applied to the tibia and fibula to achieve a relative posterior glide to the talus. The glide will be maintained while the subject actively moves their ankle to the end of pain-free dorsiflexion range of motion by lunging forward. Four sets of four repetitions with a 10 second hold at end range will be used as this has been found to be effective in improving dorsiflexion range of motion in individuals with chronic recurrent lateral ankle sprains. (Vicenzino, 2006). The mobilisation treatment sessions will be conducted 2 times per week for 3 weeks. Each session will be approximately 10 minutes in length and will be led by a physiotherapist. Participants will be emailed a reminder of the upcoming treatment session at least 24 hours before the event to improve treatment attendance.
Intervention code [1] 290094 0
Rehabilitation
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293005 0
Weight-bearing dorsiflexion range of motion:
Dorsiflexion range of motion (ROM) is determined using the weight bearing lunge test. The test assesses the maximal advancement of the tibia over the talus in a weight-bearing position. The weight-bearing lunge test has been found to have excellent inter- and intra-rater reliability (Bennell et al., 1998).

The participant stands in front of a wall with the second toe and mid-line of the heel and patella of the leg to be tested positioned perpendicular to the wall and on a line that extends from the floor up and wall. Participants are instructed to transfer their weight onto their front foot, as if they were lunging forward, while maintaining their heel firmly on the floor.

Participants must make contact with the perpendicular line on the wall with the pre-marked midpoint of the patella. The examiner places one hand behind the participant’s heel to maintain a neutral calcaneal position and ensure heel contact with the floor. Participants are instructed to stop at the first onset of pain or when they are unable to go any further. They are able to use their hands and opposite foot for balance.

The participant progressively moves the foot back to the point where the knee could just touch the wall with the heel sustained on the ground, whilst maintaining the midline positioning of the heel.

This represents end of range dorsiflexion, and the distance between the wall and second toe is measured in millimetres using a tape measure.
Timepoint [1] 293005 0
Prior to the start of treatment, after 1st set of mobilisations, and at the end of treatment
Primary outcome [2] 293006 0
Knee valgus angle:
A single leg squat will be assessed using a 2D video analysis of the frontal plane observe frontal plane projection angle for hip adduction and knee valgus. The protocol for this measure has been adapted from Wilson et al 2006 and O’Sullivan 2010. 2D methods of video analysis of frontal plane biomechanics are typically portable, inexpensive, and readily accessible to practicing clinicians. While a 2D approach has limitations in measuring knee valgus whereby it cannot capture the transverse component of the motion McLean et al 2005 concluded that despite the limitations of a 2D approach, it can be a useful estimate of knee valgus during weight-bearing activities when compared with 3D motion analysis.

Participants will first perform a single leg squat on flat ground. They will be instructed on how to perform a single leg squat and will be asked to demonstrate their technique to ensure they have fully understood. Participants will squat to 60 degrees of knee flexion. This angle will be measured with a goniometer and an adjustable height plinth will be positioned behind the subject at a height at which their bottom just touches the plinth when they squat to 60 degrees. Participants will stand on their right leg for 3 seconds with their left leg behind before performing 5 squats at a rate of 5 per 25 seconds (3 secs down, 2 secs up per squat). A metronome was used to help the subject keep time (Mobile Metronome 1.2.4). Their bottom must lightly touch the plinth behind for each squat which has been set to a height of 60 degrees of knee flexion for the subject. The subject must fully straighten their knee between squats.
Timepoint [2] 293006 0
Prior to the start of treatment and at the end of treatment
Secondary outcome [1] 310136 0
Foot and Ankle Disability Index (FADI):
The FADI has indices - a disability index that contains 26 items and a sport index that contains 8 items. Participants are asked to indicate how much difficulty they have performing tasks with possible responses raging from "no difficulty" to "unable to do". The FADI has been shown to be reliable and sensitive in deterimining functional and sport limitations in people with chronic ankle instability (Hale & Hertel 2005).
Timepoint [1] 310136 0
Prior to the start of treatment and at the end of treatment
Secondary outcome [2] 310161 0
Cumberland Ankle Instability Tool (CAIT)
The Cumberland Ankle instability Tool is a nine-item questionnaire designed to evaluate several aspects of chronic ankle instability. The CAIT is a discriminative questionnaire that can identify patients with chronic ankle instability and measure the severity of functional ankle instability. (Hertel 2008, Carcia et al, 2008)
Timepoint [2] 310161 0
Prior to the start of treatment and at the end of treatment

Eligibility
Key inclusion criteria
1. Individuals with a history of one or more ankle sprains that occurred greater than 2 months ago;
2. A 20 mm or greater decrease in ankle dorsiflexion compared to the other ankle or 60mm or less of ankle dorsiflexon bilaterally (measured using the weight-bearing lunge test) (Hock et al 2011).
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. They have had a previous surgery to the ankle that has resulted in the use of internal fixation (plates, screws or pins)
2. They have sustained an acute musculoskeletal injury to the lower extremity in the previous 2 months that has impacted joint integrity and function (ie, sprains, fractures), resulting in at least 1 interrupted day of desired physical activity (Gribble et al., 2013).
3. They are receiving any concurrent physiotherapy treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/08/2014
Actual
28/08/2014
Date of last participant enrolment
Anticipated
12/09/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 289834 0
Self funded/Unfunded
Name [1] 289834 0
N/A
Country [1] 289834 0
Primary sponsor type
University
Name
University of Queensland
Address
School of Health and Rehabilitation Sciences
The University of Queensland
St, Lucia, QLD
4072
Country
Australia
Secondary sponsor category [1] 288584 0
None
Name [1] 288584 0
Address [1] 288584 0
Country [1] 288584 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This study aims to investigate the effects of ankle mobilisations on ankle dorsiflexion ROM and its relationship to hip adduction and knee valgus in a single leg squat. Participants will be assessed before and after 6 treatment sessions over a 3 week period. Our primary aim is to determine the effect of ankle mobilisations on ankle dorsiflexion and knee valgus angle during squatting. A secondary aim is to determine whether a change in dorsiflexion range of motion following the first treatment predicts a change in dorsiflexion range of motion following the final treatment session.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50926 0
Dr Michelle Smith
Address 50926 0
The University of Queensland
School of Health and Rehabilitation Sciences
St. Lucia, QLD
4072
Country 50926 0
Australia
Phone 50926 0
61 7 3365 4660
Fax 50926 0
Email 50926 0
[email protected]
Contact person for public queries
Name 50927 0
Dr Michelle Smith
Address 50927 0
The University of Queensland
School of Health and Rehabilitation Sciences
St. Lucia, QLD
4072
Country 50927 0
Australia
Phone 50927 0
61 7 3365 4660
Fax 50927 0
Email 50927 0
[email protected]
Contact person for scientific queries
Name 50928 0
Dr Michelle Smith
Address 50928 0
The University of Queensland
School of Health and Rehabilitation Sciences
St. Lucia, QLD
4072
Country 50928 0
Australia
Phone 50928 0
61 7 3365 4660
Fax 50928 0
Email 50928 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.