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Trial registered on ANZCTR


Registration number
ACTRN12622000811707
Ethics application status
Approved
Date submitted
30/05/2022
Date registered
9/06/2022
Date last updated
25/10/2022
Date data sharing statement initially provided
9/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of ankle and proximal tibiofibular manipulations on ankle range of motion (ROM) and squat strength and biomechanics
Scientific title
The effects of ankle and proximal tibiofibular manipulations on ankle ROM and squat strength and biomechanics in adults aged 20 to 40 years with limited ankle dorsiflexion range of motion
Secondary ID [1] 307226 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankle range of motion deficits 326471 0
Condition category
Condition code
Musculoskeletal 323752 323752 0 0
Normal musculoskeletal and cartilage development and function
Physical Medicine / Rehabilitation 323808 323808 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a double-blind randomised cross-over trial with 3 sessions. Session 1 involves familiarisation with the procedures and baseline tests. Sessions 2 and 3 will involve either a series of ankle and knee manipulations, or a series of sham manipulations. Session 1 and 2 will be separated by at least three days, and session 2 and 3 by seven to eight days (wash out). Each session will last 1 - 1.5 hours. The data collector will monitor adherence to the specified time frames between sessions using a spreadsheet to track attendance.

The ankle and knee manipulations with involve a series of high velocity low amplitude thrust manipulations to bilateral ankle and knee joints, and are collectively intended to encourage mobility and especially dorsiflexion of the ankle/foot complex. Manipulations will involve:
- Talocrural joint long axis distraction
- Talocrural joint posterior glide manipulation
- Subtalar lateral glide manipulation
- Tarsometatarsal joint dorsal to plantar manipulation
- Proximal tibiofibular joint posterior to anterior manipulation

Interventions will be delivered by a registered chiropractor. A maximum of 2 attempts at each joint will be performed, based on perceived success of the first attempt. The success of the intervention at each joint will be determined subjectively by the clinician, and not necessarily based on an audible cavitation that can accompany joint manipulation.
Intervention code [1] 323675 0
Treatment: Other
Comparator / control treatment
Participants will receive bilateral ankle and knee sham manipulations consisting of mechanically-assisted thrusts using the drop mechanism of the treatment table to multiple joints. Each sham manoeuvre is intended to mimic a real manipulation but involves broad contact (not specific to any joint) and for most the “thrust” will be delivered directly into the table to trigger the drop mechanism, rather than into the patient
Control group
Placebo

Outcomes
Primary outcome [1] 331510 0
Change in lower limb strength with the 1RM barbell back squat weight (kg).
Timepoint [1] 331510 0
Session 1 (baseline), immediately post-intervention at session 2 and session 3.
Secondary outcome [1] 410126 0
Kinematic changes in the knee angles in the frontal plane (valgus/varus) during a 1RM barbell back squat
Timepoint [1] 410126 0
Immediately post-intervention at session 2 and session 3.
Secondary outcome [2] 410127 0
Force time characteristics (i.e., kinetics) of the lower limbs during a 1RM barbell back squat
Timepoint [2] 410127 0
Immediately post-intervention at session 2 and session 3.
Secondary outcome [3] 410128 0
Ankle dorsiflexion range of motion (DF-ROM) using the weight-bearing lunge test.
Timepoint [3] 410128 0
Session 1 (baseline), and immediately post-intervention at session 2 and session 3.
Secondary outcome [4] 410133 0
Blinding success measured using a study-specific questionnaire (belief about whether intervention was real or sham at session 2 and 3) and analysed using the Bang's Blinding Index.
Timepoint [4] 410133 0
At conclusion of third (final) visit
Secondary outcome [5] 410434 0
Kinematic changes in the ankle joint angles in the sagittal plane (dorsiflexion) during the 1RM barbell back squat
Timepoint [5] 410434 0
Immediately post-intervention at session 2 and session 3.

Eligibility
Key inclusion criteria
Inclusion criteria:
• Male and female participants between 20-40 years of age.
• Good physical health including no history of ankle injury (sprain and/or strain).
• Physically active, defined as a 12-month history of resistance training, including back squats averaging at least 1 session per week over the last 12 month and at least once per week for 8 weeks prior to screening
• Able to squat at least one times body weight for a 1 repetition maximum (1RM), and able to squat to a depth of at least the thigh parallel to the ground.
• Limited ankle dorsiflexion range of motion (DF-ROM), on at least one ankle of less than 44 degrees tested using the weightbearing lunge test
Minimum age
20 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
• Any contraindication to extremity manipulation therapy, including a history of neurological diseases, rheumatoid diseases, or osteoarthritis of lower limbs or spine, self-reported injury within the past 6 months to the ankle, knee or hip including minor sprain, strains or fracture, receiving any major surgery to the lower limbs in the past 12 months, receiving any surgery that included internal fixations in the lower limbs.
• Any contraindication to strenuous exercise, based on the criteria set out in stage 1 of the Exercise & Sports Science Australia (ESSA) Adult Pre-Exercise Screening System
• Any joint manipulation to the lower limbs in the past 6 weeks.
• Score of less than 80 on the Foot and Ankle Disability Index (FADI) questionnaire, indicating impaired foot and ankle function (incorporated in the Demographic and Screening Questionnaire).
• Female participants: pregnant or 3 months post-partum, or during a menstrual bleed.

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 randomised to sequence 1 or sequence 2 by a computer-generated random sequence of 1’s and 2’s, with each contained in sealed opaque envelope and opened by the investigator delivering interventions just prior to the intervention at treatment session 1
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomly-generated set of 1's and 2's created by online software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power calculation was performed using G*Power v3.1 based on Taskin et al. (2018). An effect size of 0.62 was calculated based on the 1RM back squat weight at baseline and after a lower limb tape intervention. Using the difference between two dependent means, with alpha set at 0.05 and 80% power, an a priori sample size of 23 was determined. We added 10% to account for drop out, giving a final target sample size of 26 participants.

Statistical analyses will be performed on the effect of each intervention on knee and ankle joint angles, 1RM back squat weight (kg), and ankle DF-ROM will be assessed using paired t-tests in the SPSS package version 25.0 (IBM Corporation, Armonk, NY, USA). The statistical significance level in all analyses will be set at P = 0.05. Means, standard deviations, and 95% confidence intervals for all measured variables will be calculated.
The two Kistler force plates will be used to quantify force-time parameters during the back squat. Specifically, the peak and mean force will be measured during both the descending (eccentric) and ascending (concentric) phase of the lift. Additionally, the peak and mean velocity of the system centre of mass will be calculated during the ascending phase of the lift. Finally, peak and mean power output will be determined during the concentric phase of the lift

Blinding success will be assessed using the Bang’s Blinding Index based on a table as below, which indicates the number of participant’s whose belief about the intervention they received at each visit was correct, incorrect, or unsure. The Blinding Index (BI) is then calculated according to Bang et al. (2004). This produces a BI value for each intervention between -1 and +1, where -1 indicates all guesses were incorrect and +1 indicates all guesses were correct. We will consider a scenario of “random guess” (BI = -0.2 to +0.2 for each intervention) or “wishful thinking” (equal but opposite BI, i.e. +x for the real intervention and -x for the sham) as indicating successful blinding

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/06/2022
Actual
4/07/2022
Date of last participant enrolment
Anticipated
31/10/2022
Actual
Date of last data collection
Anticipated
31/01/2023
Actual
Sample size
Target
23
Accrual to date
13
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 311524 0
University
Name [1] 311524 0
Murdoch University
Country [1] 311524 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South St, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 312953 0
None
Name [1] 312953 0
Address [1] 312953 0
Country [1] 312953 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310984 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 310984 0
Ethics committee country [1] 310984 0
Australia
Date submitted for ethics approval [1] 310984 0
13/04/2022
Approval date [1] 310984 0
03/06/2022
Ethics approval number [1] 310984 0
2022/085

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119586 0
Dr Sasha Aspinall
Address 119586 0
College of Science, Health, Engineering and Education
Murdoch University
90 South St, Murdoch WA 6150
Country 119586 0
Australia
Phone 119586 0
+61 08 9360 2114
Fax 119586 0
Email 119586 0
Sasha.Aspinall@murdoch.edu.au
Contact person for public queries
Name 119587 0
Reneigh Morley-Hart
Address 119587 0
College of Science, Health, Engineering and Education
Murdoch University
90 South St, Murdoch WA 6150
Country 119587 0
Australia
Phone 119587 0
+61 08 9360 2114
Fax 119587 0
Email 119587 0
32905125@student.murdoch.edu.au
Contact person for scientific queries
Name 119588 0
Sasha Aspinall
Address 119588 0
College of Science, Health, Engineering and Education
Murdoch University
90 South St, Murdoch WA 6150
Country 119588 0
Australia
Phone 119588 0
+61 08 9360 2114
Fax 119588 0
Email 119588 0
Sasha.Aspinall@murdoch.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.