Protocol summary

Summary
The purpose of this study is to determine the effect of functional fatigue in flat feet and normal feet subjects. This study is not randomized and not blinded. 32 subjects (16 normal feet and 16 bilateral flexible flat feet) without any visual malalignment in lower extremity and lumbosacral area will complete three trials of barefoot walking across the force plates before fatigue. These three trials will be repeated after warm-up and doing functional fatigue protocol for each subject. Different components of ground reaction force will be analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138905114441N3
Registration date: 2010-09-23, 1389/07/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-09-23, 1389/07/01
Registrant information
Name
Hassan Jafari
Name of organization / entity
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912139131382
Email address
hjafari@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2010-06-15, 1389/03/25
Expected recruitment end date
2010-08-15, 1389/05/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of functional fatigue on ground reaction force among individuals with flat feet
Public title
Fatigue effect on ground reaction force in Flatfoot Patients
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18-40, Bilateral flexible flat foot Exclusion criteria: any visual sign of lower limb or lumbosacral malalignment, a limb length discrepancy greater than 1 cm, a history of lower extremity or lumbosacral injury during 6 months prior to the study, history of foot and ankle surgery, neurological and or musculoskeletal disorder suffering from pain during the test
Age
From 18 years old to 40 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 16
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Rehabilitation Sciences Faculty (IUMS) Ethics Committee
Street address
Faculty of Rehabilitation Sciences, Shahnazari St, Madar Ave, Mirdamad Blvd
City
Tehran
Postal code
1545913187
Approval date
2010-06-20, 1389/03/30
Ethics committee reference number
244

Health conditions studied

1

Description of health condition studied
Flexible Flat Foot
ICD-10 code
Q66.5
ICD-10 code description
Congenital pes planus

Primary outcomes

1

Description
1st and 2nd peak and the minimum value of vertical ground reaction force
Timepoint
Before and after functional fatigue protocol
Method of measurement
Force plate

Secondary outcomes

empty

Intervention groups

1

Description
Fatigue Protocol: 5 sets of serial hops with the metronome rate of 108 bpm.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Sahar Boozari
Street address
Faculty of Rehabilitation Sciences, Shahnazari St, Madar Ave, Mirdamad Blvd
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for Resaech, Iran University of Medical Sciences
Full name of responsible person
Dr Maziar Moradi Lakeh
Street address
Iran University of Medical Sciences, Hemmat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Resaech, Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Hassan Jafari
Position
PHD of physiotherapy
Other areas of specialty/work
Street address
Faculty of Rehabilitation Sciences, Shahnazari St, Madar Ave, Mirdamad Blvd
City
Tehran
Postal code
1545913187
Phone
+98 21 2222 7124 ext. 202
Fax
+98 21 2222 0946
Email
hassan.jafari@live.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Rehabilitation Sciences, Iran University of Medical University,
Full name of responsible person
Ali Ashraf Jamshidi
Position
Master student of physiotherapy
Other areas of specialty/work
Street address
Faculty of Rehabilitation Sciences, Shahnazari St, Madar Ave, Mirdamad Blvd
City
Tehran
Postal code
1545913187
Phone
+98 21 2222 7124 ext. 202
Fax
Email
aliajamshidi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Rehabilitation Sciences, Iran University of Medical University,
Full name of responsible person
Sahar Boozari
Position
Master student of physiotherapy
Other areas of specialty/work
Street address
Faculty of Rehabilitation Sciences, Shahnazari St, Madar Ave, Mirdamad Blvd
City
Tehran
Postal code
1545913187
Phone
+98 21 2222 7124 ext. 202
Fax
Email
saharboozari@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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