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
ACTRN12618001679279
Ethics application status
Approved
Date submitted
18/09/2018
Date registered
11/10/2018
Date last updated
18/12/2018
Date data sharing statement initially provided
18/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Immediate effects of direct thrust manipulation of talus in the dorsiflexion range of movement, posterior talar glide and dynamic postural control.
Scientific title
Immediate effects of direct High-Velocity Low-Amplitude (HVLA) thrust manipulation of talus in the dorsiflexion range of movement, posterior talar glide and dynamic postural balance in individuals with a history ankle sprain.
Secondary ID [1] 296118 0
Nil known
Universal Trial Number (UTN)
U1111-1217-3768
Trial acronym
Linked study record
No identifying number available

Health condition
Health condition(s) or problem(s) studied:
Ankle sprain 309697 0
Condition category
Condition code
Physical Medicine / Rehabilitation 308502 308502 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 308710 308710 0 0
Other injuries and accidents
Musculoskeletal 308735 308735 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: HVLA Thrust Direct manipulation of talus with a drop table: the individual is lying on the table with the lower limb in triple flexion. The calcaneus rests on the drop table, which is armed and, the foot rests on a Dejarnete's wedge, which fixes the foot in the first degrees of plantar flexion. The therapist stands in front of the individual on the side of the dysfunction and makes contact with the inner hand with the pisiform on the neck of the talus, and the external hand reinforces the anterior hand. The forearms should lie in the joint plane of the talocrural joint. The slack is reduced and through an explosive contraction of the pectorals, the manipulation with thrust is carried out, associated with a body-drop.

The intervention will be administered by a Physiotherapist with 10 years experience;

Number of times: Three (3) consecutive times;

Duration between each manipulation: 10 seconds

Number of sessions: a single intervention.

Duration of intervention: 3 minutes

Location: Public Hospital
Intervention code [1] 312446 0
Treatment: Other
Intervention code [2] 312597 0
Rehabilitation
Comparator / control treatment
No treatment.

Same position of treatment group but no treatment thrust manipulation;

A Physiotherapist with 10 years experience will put your hands in the ankle;

Duration: 30 secondes.

Number of times: once time in a single session
Control group
Placebo

Outcomes
Primary outcome [1] 307476 0
Dorsiflexion range of movement is assessed with a weight-bearing ankle lunge test (functional test, which we take the maximum distance between the second toe of the foot and the wall, at the maximum of dorsiflexion in weight-bearing).
Timepoint [1] 307476 0
Baseline, immediately and 30 minutes after the intervention
Primary outcome [2] 307477 0
Posterior talar glide with a bubble inclinometer
Timepoint [2] 307477 0
Baseline, immediately and 30 minutes after the intervention
Primary outcome [3] 307478 0
Dynamic postural balance with the "Y Balance Test"
Timepoint [3] 307478 0
Baseline, immediately and 30 minutes after the intervention
Secondary outcome [1] 352021 0
Nil
Timepoint [1] 352021 0
Nil

Eligibility
Key inclusion criteria
Individuals between 25 and 45 years of age;
History of one or more episodes of unilateral ankle sprain;
A dorsiflexion deficit at least 10 millimeters on the unilateral affected side compared to the non affected side.
Minimum age
25 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of fracture or surgery in the foot, knee or hip;
History of acute ankle sprain in the last 6 months;
Individuals who received a osteopathic treatment in the last of 3 months;
Presence of swelling or severe vascular disease;
Medical treatment in the last 72 hours;
Contraindications of weight-bearing position;
Individuals who are contraindicated the application of the techniques or assessment of the outcomes.

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)
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
17/10/2018
Actual
1/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
15
Final
Recruitment outside Australia
Country [1] 20852 0
France
State/province [1] 20852 0
Pont de Beauvoisin

Funding & Sponsors
Funding source category [1] 300707 0
Self funded/Unfunded
Name [1] 300707 0
Nuno Pinheiro
Country [1] 300707 0
France
Primary sponsor type
Individual
Name
Nuno Alexandre Fernandes Pinheiro
Address
The Madrid School of Osteopathy (EOM - Madrid)
Nuno Pinheiro
Rue du Thomassin
38480 Pont de Beauvoisin
Country
France
Secondary sponsor category [1] 300241 0
None
Name [1] 300241 0
Address [1] 300241 0
Country [1] 300241 0
Other collaborator category [1] 280356 0
Individual
Name [1] 280356 0
Sofia Lopes Santos
Address [1] 280356 0
Hospital Group of Pont de Beauvoisin
Sofia Lopes Santos
Rue du Thomassin
38480 Pont de Beauvoisin
Country [1] 280356 0
France

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301491 0
The Local ethics committee of GHND (Hospital Group Nord Dauphiné) - Pont de Beauvoisin
Ethics committee address [1] 301491 0
Ethics committee country [1] 301491 0
France
Date submitted for ethics approval [1] 301491 0
17/09/2018
Approval date [1] 301491 0
29/10/2018
Ethics approval number [1] 301491 0

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

Contacts
Principal investigator
Name 87178 0
Mr Nuno Alexandre Fernandes Pinheiro
Address 87178 0
The Madrid School of Osteopathy (EOM)
Nuno Alexandre Fernandes Pinheiro
Rue du Thomassin
38480 Pont de Beauvoisin
Country 87178 0
France
Phone 87178 0
+33604527571
Fax 87178 0
Email 87178 0
[email protected]
Contact person for public queries
Name 87179 0
Nuno Alexandre Fernandes Pinheiro
Address 87179 0
The Madrid School of Osteopathy (EOM)
Nuno Alexandre Fernandes Pinheiro
Rue du Thomassin
38480 Pont de Beauvoisin
Country 87179 0
France
Phone 87179 0
+33604527571
Fax 87179 0
Email 87179 0
[email protected]
Contact person for scientific queries
Name 87180 0
Nuno Alexandre Fernandes Pinheiro
Address 87180 0
The Madrid School of Osteopathy (EOM)
Nuno Alexandre Fernandes Pinheiro
Rue du Thomassin
38480 Pont de Beauvoisin
Country 87180 0
France
Phone 87180 0
+33604527571
Fax 87180 0
Email 87180 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Anyone who wishes to access it, to prove the results of the study.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Only by request to the investigator through personal email.


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.