Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001207505
Ethics application status
Approved
Date submitted
27/03/2015
Date registered
5/11/2015
Date last updated
5/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Immediate effects in Baropodometry and Stabilometry of manipulation of the hindfoot and midfoot in patients with grade II ankle sprain.
Scientific title
Effects of hindfoot and midfoot manipulation on load distribution in patients aged 18 to 45 years with grade II ankle sprain.
Secondary ID [1] 286416 0
None
Universal Trial Number (UTN)
U1111-1163-3854
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Grade II ankle sprain 294583 0
Condition category
Condition code
Musculoskeletal 294884 294884 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 294885 294885 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of some manipulations.
Manipulations are performed by an osteopath DO immediately after the initial evaluation baropodometric with one sitting of about 5 minutes.
The study includes three groups:
GH: osteopathic manipulation of the hindfoot that includes the manipulations of cuboid bone, navicular bone more talus and calcaneus bones. This group is carried out in an osteopathic technique of talocrural joint manipulation; an osteopathic technique of posterior gliding manipulation of the talus bone; an osteopathic technique for the opening of the talus-calcaneus joint.
GM: osteopathic manipulation of the midfoot that includes the manipulation of cuboid bone and navicular bone. This group is carried out in osteopathic techniques previous and in addition a technique for the inferiority of cuboid and navicular bones.
GC: control group with placebo technique.
This technique consists of a simple manual contact on the ankle for about 1 minute.
Intervention code [1] 291490 0
Rehabilitation
Intervention code [2] 291704 0
Treatment: Other
Comparator / control treatment
control group (GC):
This group is carried out in a technique placebo that consists of a simple manual contact on the ankle without movement for about 1 minute.
Control group
Placebo

Outcomes
Primary outcome [1] 294639 0
Load percentage on forefoot and hindfoot as measured by Baropodometry platform
Timepoint [1] 294639 0
pre- and immediately post intervention
Primary outcome [2] 294886 0
Percentage of the total load on the foot as measured by baropodometriy platform
Timepoint [2] 294886 0
pre and immediately post intervention
Secondary outcome [1] 313780 0
nil
Timepoint [1] 313780 0
nil

Eligibility
Key inclusion criteria
patients with grade II ankle sprain between the tenth and ninetieth day after the event;patients between 18 and 45 years; patients who signed the informed consent form.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with recent trauma less than 10 days; infected patients in the acute phase; patients with neurological diseases; patients with mental disorders, metabolic, with means of synthesis surgical lower limbs.

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)
Each subject is assigned an increasing number starting with one in the order of arrival. Subsequently, the program RANDOM.COM will assign the subject to each of the three study groups
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Use of the program RANDOM.COM
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/12/2014
Date of last participant enrolment
Anticipated
Actual
31/08/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
75
Recruitment outside Australia
Country [1] 6777 0
Italy
State/province [1] 6777 0
Bergamo

Funding & Sponsors
Funding source category [1] 291150 0
Self funded/Unfunded
Name [1] 291150 0
Cristian Quagliati
Country [1] 291150 0
Primary sponsor type
Individual
Name
Cristian Quagliati
Address
EOM - Escuela de Osteopatia de Madrid,

San Felix de Alcala 4 street -
28807 Alcala de Henares,
Madrid (Spain).
Country
Spain
Secondary sponsor category [1] 289678 0
None
Name [1] 289678 0
Address [1] 289678 0
Country [1] 289678 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293448 0
Comite Etico de Experimentacion SEFO
Ethics committee address [1] 293448 0
Ethics committee country [1] 293448 0
Spain
Date submitted for ethics approval [1] 293448 0
25/10/2014
Approval date [1] 293448 0
27/10/2014
Ethics approval number [1] 293448 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 552 552 0 0
/AnzctrAttachments/368249- COMITE ETICO SEFO.pdf

Contacts
Principal investigator
Name 56054 0
Mr Quagliati Cristian
Address 56054 0
Mr Quagliati Cristian,Dante Alighieri 12/A street, 24060,
Torre de'Roveri (Bergamo)

EOM - Escuela de Osteopatia de Madrid
San Felix de Alcala 4 Street -
28807 Alcala de Henares.
Madrid

Country 56054 0
Italy
Phone 56054 0
+39 3494434198
Fax 56054 0
Email 56054 0
[email protected]
Contact person for public queries
Name 56055 0
Quagliati Cristian
Address 56055 0
EOM - Escuela de Osteopatia de Madrid
San Felix de Alcala 4,
28807 Alcala de Henares.
Madrid
Country 56055 0
Spain
Phone 56055 0
+39349 4434198
Fax 56055 0
Email 56055 0
[email protected]
Contact person for scientific queries
Name 56056 0
Quagliati Cristian
Address 56056 0
EOM - Escuela de Osteopatia de Madrid
San Felix de Alcala 4 street,
28807 Alcala de Henares.
Madrid.
Country 56056 0
Spain
Phone 56056 0
+39349 4434198
Fax 56056 0
Email 56056 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
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Documents added automatically
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