Protocol summary
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Study aim
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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.
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Design
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A concealed, randomized, blinded, sham controlled clinical trial with a parallel group design of 40 patients, will enrolled between April 2019 and September 2019.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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)
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Intervention groups
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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.
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Main outcome variables
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1. Isokinetic strength of knee flexors and extensors
2. Isokinetic strength of ankle plantar flexors and dorsi-flexors
General information
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Reason for update
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Acronym
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WBV
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IRCT registration information
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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
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Registration date
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2019-03-02, 1397/12/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-04-21, 1398/02/01
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Expected recruitment end date
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2019-09-23, 1398/07/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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The effect of Whole body vibration on the flat foot
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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)
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Age
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From 12 years old to 30 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Investigator
- Outcome assessor
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-02-20, 1397/12/01
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Ethics committee reference number
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IR.SEMUMS.REC.1397.266
Health conditions studied
1
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Description of health condition studied
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Flat foot
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ICD-10 code
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M21.4
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ICD-10 code description
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Flat foot [pes planus] (acquired)
Primary outcomes
1
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Description
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Isokinetic strength of knee flexors and extensors, ankle plantar and dorsi-flexors
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Timepoint
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Measurement of the strength before and immediately after 10 sessions of whole body vibration
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Method of measurement
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Isokinetic power measuring device
2
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Description
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Static and dynamic balance
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Timepoint
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Pre and post intervention
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Method of measurement
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BIODEX instrument
Secondary outcomes
1
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Description
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Foot posture index (FPI)
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Timepoint
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Before first session and after the 10th session of whole body vibration
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Method of measurement
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Foot posture index
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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Control group: Corrective foot exercises for 10 sessions, 3 sessions per week and 30 minutes per session
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Semnan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No more information.
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Only part of the data, such as the primary outcome, can be released.
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When the data will become available and for how long
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Start the access period 6 months after publishing the results
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To whom data/document is available
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I have not decided yet - its release plan is still unknown
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Under which criteria data/document could be used
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I have not decided yet - its release plan is still unknown
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From where data/document is obtainable
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I have not decided yet - its release plan is still unknown
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What processes are involved for a request to access data/document
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I have not decided yet - its release plan is still unknown
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Comments
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