Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001759189
Ethics application status
Approved
Date submitted
5/10/2019
Date registered
11/12/2019
Date last updated
11/12/2019
Date data sharing statement initially provided
11/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects on the gait cycle analysis and postural stability analysis of a thin mechanical stimulation on the plantar arch applied on a sample of healthy subjects.
Scientific title
Proprioceptive Effects Of The Mechanical Stimulation By An Internal And External Heel Wedge: Modification Of The Functional Relationships On The Gait Cycle And Postural Stability.
Secondary ID [1] 299484 0
None
Universal Trial Number (UTN)
U1111-1241-5489
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of postural dysfunctions 314714 0
Condition category
Condition code
Physical Medicine / Rehabilitation 313051 313051 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aimed to verify if the insertion of an Internal Heel Wedge (IHW) and External Heel Wedge (EHW) could modify the stabilometric and podobarometric variables, functional changes during the gait cycle, different responses between the dominating lower limb and non-dominating lower limb and potential temporal summations of the proprioceptive stimulation. The IHW and EHW will be made out of a cork half-moon having a thickness of 1.5 mm, length of 6 cm and height of 3 cm and will be worn on both feet: in the first instance with IHW on both feet and then with EHW on both feet. The duration of the intervention will be 15 minutes and will be administered by university researchers. The duration of time between the first trials (with Internal Heel Wedge) and the second trials (with External Heel Wedge) will be of 1 week. In this way we foresee two visit with the subjects recruited. The sequence of tests will be performed without IHW or EHW (Baseline), trials with IHW or EHW (Acute), trials after an adaptation period of 15 minutes on a treadmill with IHW or EHW (after 15’). There will be 2 period of adaptations to the mechanical stimulation: first with Internal Heel Wedge, then with External Heel Wedge. The period of adaptations will be performed on a treadmill, where the subjects will walk for 15 minutes at the speed of 4km/h and a 0° inclination.
Intervention code [1] 315736 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321603 0
Functional changes during the gait cycle and postural stability assessed by means G-Walk (Gait cycle analysis) and P-Walk (stabilometric and podobarometric analyses).
Timepoint [1] 321603 0
The sequence of tests foresaw trials without IHW or EHW (Baseline), trials with IHW or EHW (Acute), trials after an adaptation period of 15 minutes on a treadmill with IHW or EHW (after 15’)
Secondary outcome [1] 375557 0
Duration of functional change as assessed by Gait Cycle Analysis
Timepoint [1] 375557 0
Single assessment at 3 months post-enrolment

Eligibility
Key inclusion criteria
Right dominating lower limb.
Minimum age
25 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Presence of dysmorphic features of the spine and lower limbs, recent fractures of the skeleton of the lower extremities, neurological diseases, recent muscular injuries.

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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/12/2019
Actual
Date of last participant enrolment
Anticipated
27/12/2019
Actual
Date of last data collection
Anticipated
2/03/2020
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 21907 0
Italy
State/province [1] 21907 0
Torino

Funding & Sponsors
Funding source category [1] 303980 0
Self funded/Unfunded
Name [1] 303980 0
Marco Alessandria
Country [1] 303980 0
Italy
Primary sponsor type
Individual
Name
Marco Alessandria
Address
Adapted Training and Performance - Research group. Piazza Bernini 12, 10140, TORINO, Italia.
Country
Italy
Secondary sponsor category [1] 304152 0
None
Name [1] 304152 0
Address [1] 304152 0
Country [1] 304152 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304479 0
University of Turin
Ethics committee address [1] 304479 0
Via Verdi, 8 - 10124 Torino
Ethics committee country [1] 304479 0
Italy
Date submitted for ethics approval [1] 304479 0
Approval date [1] 304479 0
02/05/2019
Ethics approval number [1] 304479 0

Summary
Brief summary
This study aims to verify if the insertion of an Internal Heel Wedge (IHW) and External Heel Wedge (EHW) can modify the stabilometric and podobarometric variables, the functional changes during the gait cycle, the different responses between the dominating lower limb and the non-dominating lower limb, and the potential temporal summations of the proprioceptive stimulation. The IHW and EHW will be made out of a cork half-moon with a 1.5mm thickness, 6cm length and 3cm height. The sequence of tests wil be performed without IHW or EHW (Baseline), trials with IHW or EHW (Acute), trials after an adaptation period of 15 minutes on a treadmill with IHW or EHW (after 15’). We hypothesize that a thin mechanical stimulation placed on the plantar arch will be enough to produce functional changes during the gait cycle, and improve postural stability.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97090 0
Prof Marco Alessandria
Address 97090 0
Adapted Training and Performance - Research group. Piazza Bernini 12, 10140, TORINO, Italia.
Country 97090 0
Italy
Phone 97090 0
+390117727854
Fax 97090 0
Email 97090 0
[email protected]
Contact person for public queries
Name 97091 0
Marco Alessandria
Address 97091 0
Adapted Training and Performance - Research group. Piazza Bernini 12, 10140, TORINO, Italia.
Country 97091 0
Italy
Phone 97091 0
+390117727854
Fax 97091 0
Email 97091 0
[email protected]
Contact person for scientific queries
Name 97092 0
Marco Alessandria
Address 97092 0
Adapted Training and Performance - Research group. Piazza Bernini 12, 10140, TORINO, Italia.
Country 97092 0
Italy
Phone 97092 0
+390117727854
Fax 97092 0
Email 97092 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 of published results only
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Only researchers
Available for what types of analyses?
Any purpose
How or where can data be obtained?
[email protected]


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.