Protocol summary

Summary
The aim of this research is to detect the effect of whole body vibration on static balance and torque of invertor and evertor muscles of ankle in persons with low arched feet.volunteers will be placed into normal and low arch feet groups. before intervention the static balance and the torque of invertor and evertor muscles will be measured by force plate and isokinitic dynamometer respectivily. The low arched feet participants will be randomly devided into two groups. one group will recieve Whole Body Vibration 6 weeks,3 times in every week and the other group will receive no intervention. 6 weeks after Whole Body Vibration the balance and torque will be assesed in both groups again.For following up the results of research we do all measurments 4 weeks after again for intervention group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201110255112N4
Registration date: 2013-07-23, 1392/05/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-07-23, 1392/05/01
Registrant information
Name
Rozita Hedayati
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1335 4180
Email address
hedayati@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences
Expected recruitment start date
2012-10-01, 1391/07/10
Expected recruitment end date
2013-12-31, 1392/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of whole body vibration on static balance and torque of invertor and evertor muscles of ankle in low arched feet
Public title
The effect of whole body vibration on balance and ankle muscle torque in low arched feet
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:No history of congenital deformity in the lower extremity or foot; No previous history of lower extremity or foot fractures; No systemic diseases that could affect lower extremity or foot posture; No history of trauma or pain to either foot, lower extremity, or lumbosacral region at least 12 months prior to the start of the investigation. Exclusion criteria : Any visual signs of hallux valgus, hallux limitus/rigidus, claw toes, or hammer toes; Pain; Abnormal gait; Medical insoles; Muscular disease or neuromuscular disease
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
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
Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, The 5th kilometers of Damghasn road
City
Semnan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
پس از طرح در كميته اخلاق دانشگاه علوم پزشكي سمنان ثبت م

2

Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, The 5th Kilometer of Dameghan Road
City
Semnan
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
پس از طرح در كميته اخلاق دانشگاه علوم پزشكي سمنان ثبت م

Health conditions studied

1

Description of health condition studied
low arched feet
ICD-10 code
Q 66.5
ICD-10 code description
Diseases of the muscloskeletal syatem and connective tissue

Primary outcomes

1

Description
Center of Pressuere Velocity
Timepoint
Beginning of the study, 6 weeks after, 10 weeks after
Method of measurement
force plate

2

Description
Center of Pressure Displacement
Timepoint
Beginning of the study, 6 weeks after, 10 weeks after
Method of measurement
Forceplate

3

Description
Muscle Torque
Timepoint
Beginning of the study, 6 weeks after, 10 weeks after
Method of measurement
Dynamometers

Secondary outcomes

empty

Intervention groups

1

Description
In intervention group: whole body vibration frequency=26 Hz set:6 duration: 60 second interval rest: 60 sec total duration: 6 weeks 3 times a week
Category
Treatment - Devices

2

Description
control group: No Intervention 9
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences
Full name of responsible person
Dr. Rozita Hedayati
Street address
Semnan University of Medical Sciences, The 5th Kilometers of Damghan Road
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences
Full name of responsible person
Dr AmirHushang Bakhtiary
Street address
No 5, Ghods Bolveder, Semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neuromuscular Rehabilitation Research Center, Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Dr. Rozita Hedayati
Position
Ph.D, Assisstant professor
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, The 5th kilometers of Damghan road, Semnan
City
Semnan
Postal code
Phone
+231 3354180
Fax
Email
Rosehed@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Rozita Hedayati
Position
Ph.D
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, The 5th kilometers of Damghan road, Semnan
City
Semnan
Postal code
Phone
+231 3354180
Fax
Email
Rosehed@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Rozita Hedayati
Position
Assistant Professor / Ph.D
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, The 5th kilometers of Damghan Road, Semnan
City
Semnan
Postal code
Phone
+231 3354180
Fax
Email
roserhed@yahoo.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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