The Effects of Whole Body Vibration on Balance and Muscles Strength in Lower Extremities in Flat Foot individuals, during and after the developing age, after fatigue Conditions.
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General information
The Effects of Whole Body Vibration on Muscles Strength in Lower Extremities in Flat Foot individuals, during and after the developing age, after fatigue Conditions.
The Effects of Whole Body Vibration on Balance and Muscles Strength in Lower Extremities in Flat Foot individuals, during and after the developing age, after fatigue Conditions.
The Effects of Whole Body Vibration on Balance and Muscles Strength in Lower Extremities in Flat Foot individuals, during and after the developing age, after fatigue Conditions.
تاثیر ارتعاش کل بدن بر قدرت عضلات اندام های تحتانی در افراد دچار صافی کف پا حین و بعد از سن رشد، در شرایط خستگی
تاثیر ارتعاش کل بدن بر تعادل و قدرت عضلات اندام های تحتانی در افراد دچار صافی کف پا حین و بعد از سن رشد، در شرایط خستگی
تاثیر ارتعاش کل بدن بر تعادل و قدرت عضلات اندام های تحتانی در افراد دچار صافی کف پا حین و بعد از سن رشد، در شرایط خستگی
Protocol summary
Study aim
The purpose of this study is to investigate the effect of Whole body vibration on limb muscle torque following fatigue in subjects with flat foot during and after the growth age.
Design
A concealed, randomized, blinded, sham controlled clinical trial with a parallel group design of 40 patients, will enrolled between April 2019 and September 2019.
Settings and conduct
This study will be carried out at the Neuromuscular Rehabilitation Center of Semnan University of Medical Sciences. After allocation, two groups were randomly assigned into intervention and control groups, a blinded assessor, will evaluate the strength of the dominant lower extremity muscles, pre and post fatigue protocol using isokinetic device. Then, an experienced physiotherapist, intervened the participants via the whole body vibration for the intervention group for 10 sessions.After the intervention, the strength of the lower limb muscles before and after the fatigue condition by evaluator that was blinded to grouping as the beginning of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Individuals with flat feet aged between 12 and 30 year
2-BMI 20-25
3. Having an index of 6 in foot posture index
Exclusion criteria:
1. Neuromuscular, rheumatic diseases, and any disturbances in balance
2-structural flatfoot (with doctor's diagnosis)
Intervention groups
In this study, subjects with flat foot in two age groups including during and after age of growth, will assigned into two intervention and control groups.
Main outcome variables
1. Isokinetic strength of knee flexors and extensors
2. Isokinetic strength of ankle plantar flexors and dorsi-flexors
General information
Reason for update
Acronym
WBV
IRCT registration information
IRCT registration number:IRCT20160808029264N4
Registration date:2019-03-02, 1397/12/11
Registration timing:prospective
Last update:2019-10-01, 1398/07/09
Update count:2
Registration date
2019-03-02, 1397/12/11
Registrant information
Name
Rasool Bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3344 1022
Email address
rasool.bagheri@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Whole Body Vibration on Balance and Muscles Strength in Lower Extremities in Flat Foot individuals, during and after the developing age, after fatigue Conditions.
Public title
The effect of Whole body vibration on the flat foot
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Individuals with flat feet aged between 12-30 years
2-BMI of 20-25
3-Having an flat foot posture index above 6
Exclusion criteria:
1-neuromuscular diseases
2. History of any musculoskeletal disorder
3. History of fractures in the limbs and spine
4. History of rheumatic diseases
5. History of mental illness
6. Any drug use
7. Any disturbances in balance
8-Structural flatfoot (with doctor's diagnosis)
Age
From 12 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects were randomly assigned into two age groups of 12-18 years of age (growth ages) and 20-30 years old (after age of growth), according to inclusion criteria. Then, in each age group, subjects were randomly assigned In both intervention and control groups. So, in general, this study has four groups. After inclusion the study, the subjects will be randomly assigned to each intervention and control group by simple method using a random numbers table.
Blinding (investigator's opinion)
Double blinded
Blinding description
1. The person who evaluates the results of the study will also blind the allocation of the groups.
2. An individual analyzing the results will also blind the allocation of groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Comitee of Semnan University of Medical Sciences
Street address
Basij Blvd, Semnan, Semnan Province.
City
Semnan
Province
Semnan
Postal code
۹۹۹۵۱- ۳۵۱۹۸
Approval date
2019-02-20, 1397/12/01
Ethics committee reference number
IR.SEMUMS.REC.1397.266
Health conditions studied
1
Description of health condition studied
Flat foot
ICD-10 code
M21.4
ICD-10 code description
Flat foot [pes planus] (acquired)
Primary outcomes
1
Description
Isokinetic strength of knee flexors and extensors, ankle plantar and dorsi-flexors
Timepoint
Measurement of the strength before and immediately after 10 sessions of whole body vibration
Method of measurement
Isokinetic power measuring device
2
Description
Static and dynamic balance
Timepoint
Pre and post intervention
Method of measurement
BIODEX instrument
Secondary outcomes
1
Description
Foot posture index (FPI)
Timepoint
Before first session and after the 10th session of whole body vibration
Method of measurement
Foot posture index
Intervention groups
1
Description
Intervention group: Whole body vibration for 10 sessions, 3 sessions per week at 35 Hz, 10 repetitions with 60 seconds, 60 seconds rest between each repetition.
Category
Rehabilitation
2
Description
Control group: Corrective foot exercises for 10 sessions, 3 sessions per week and 30 minutes per session
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn-e-Sina Rehabilitation Clinic
Full name of responsible person
Rasool Bagheri
Street address
Next to Sepah Bank., 17 shahrivar Blvd., Semnan town
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3336 4180
Email
Rasool.bagheri@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Parviz Kokhaei, Research & Technology Deputy of University
Street address
Basij Blvd., Semnan., Semnan Province
City
Semnan
Province
Semnan
Postal code
99951- 35198
Phone
+98 23 3334 1022
Email
rasool.bagheri@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Akbar Pahlavanian
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Basij Blvd.,Semnan., Semnan Province
City
Semnan
Province
Semnan
Postal code
99951- 35198
Phone
+98 23 3334 1022
Email
rasool.bagheri@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Rasool Bagheri
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Basij Blvd., Semnan., Semnan Province
City
Semnan
Province
Semnan
Postal code
99951- 35198
Phone
+98 23 3334 1022
Email
rasool.bagheri@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Rasool Bagheri
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Next to Sepah Bank., 17 Shahrivar Blvd., Semnan Town
City
Semnan
Province
Semnan
Postal code
3513135111
Phone
+98 23 3336 4180
Email
Rasool.bagheri@ymail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only part of the data, such as the primary outcome, can be released.
When the data will become available and for how long
Start the access period 6 months after publishing the results
To whom data/document is available
I have not decided yet - its release plan is still unknown
Under which criteria data/document could be used
I have not decided yet - its release plan is still unknown
From where data/document is obtainable
I have not decided yet - its release plan is still unknown
What processes are involved for a request to access data/document
I have not decided yet - its release plan is still unknown