Effect of Whole-body Vibration on the Ankle Joint, Plantar Pressure, and Running Paramethers

January 24, 2024 updated by: Gdansk University of Physical Education and Sport

The main purpose of this study was the assessment of whole-body vibration warm-up, modified drop jumps, and combination of both on the range of motion of dorsiflexion in the ankle joint and running time. 16 recreationally active runners performed 4 different warm-up variants one week apart: 5 sets of 30 s calf raises on the platform but without vibration (CTRL), the same as CTRL group but with vibration with 30 s rest intervals between sets (WBV), 6 drop jumps with a 30 s rest interval between sets (DJ); last group was combination of both WBV and DJ groups (WBV+DJ). The study included muscle flexibility tests for the soleus and gastrocnemius muscles performed before the warm-up, 3 minutes after warm-up and immediately after a 3000 m run on a treadmill. The running time was measured and the run had to be completed in the shortest possible time.

Additionally, in the third week of the study there were performed static and dynamic foot measurements immediately before and after a 3000 m treadmill run. The main purpose of that gait analysis was to assess the impact of a 3km run on plantar pressure patterns and gait parameters in recreational runners.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Pomorskie
      • Gdańsk, Pomorskie, Poland, 80-336
        • Gdansk University of Physical Education and Sport

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • healthy and recreationally active males
  • minimum two years of running training experience

Exclusion Criteria:

  • rheumatological disease
  • neurological disease
  • orthopaedic disease
  • genetic disease
  • cardiovascular system disease
  • pain in lower limbs in the last year
  • pain in lumbar spine in the last year
  • surgeries of lower limbs in the last year
  • surgeries of spine in the last year
  • musculoskeletal injuries in the lower limbs in the last year
  • musculoskeletal injuries in the lumbar spine in the last year
  • the absence during one or more training day

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: warm-up intervention

Each participant performed all warm-up variants one week apart, without the possibility of repeating:

CTRL 5 sets of 30 s calf raises on the platform but without vibration with 30 s rest intervals between sets; WBV 5 sets of 30 s calf raises on the vibration platform with 30 s rest intervals between sets; DJ 6 modified drop jump with a 30 s rest interval between sets (DJ); WBV + DJ 5 sets of 30 s calf raises on the vibration platform followed by 6 drop jumps with a 30 s rest interval between sets
Device: LADY 1 Pro, New Life Balance
whole-body vibration training on the platform
Other: exercises
calf raises and modified drop jumps

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ankle dorsiflexion range of motion (Gastrocnemius muscle flexibility test)
Time Frame: 3 times - before the warm-up, 3 minutes after warm-up and immediately after a 3000 m run
The participant laid in a supine position with his knee straight and his ankle joint off the table. The researcher 1 tested the maximum dorsiflexion of the foot and controlled the position of the knee. The researcher 2 applied the AMI digital inclinometer (OPIW, Poland) to the outer edge of the foot. The The angle of dorsiflexion was measured in degrees.
3 times - before the warm-up, 3 minutes after warm-up and immediately after a 3000 m run
Ankle dorsiflexion range of motion (Soleus muscle flexibility test)
Time Frame: 3 times - before the warm-up, 3 minutes after warm-up and immediately after a 3000 m run
The participant laid in a supine position with the knee bent 90 degrees. The researcher 1 performed passive maximum dorsiflexion of the foot. The researcher 2 applied the AMI digital inclinometer (OPIW, Poland) to the outer edge of the foot. The angle of dorsiflexion was measured in degrees.
3 times - before the warm-up, 3 minutes after warm-up and immediately after a 3000 m run
Static foot analysis (FootScan platform)
Time Frame: 2 times - immediately before and after 3000 m run
In static measurement participants stood barefoot on the Footscan platform at a designated point, assuming a relaxed and natural position, remaining still and looking straight ahead with their arms by their sides. Static paramethers include the pressure of the parts of each foot (impulse - Ns/cm).
2 times - immediately before and after 3000 m run
Dynamic foot analysis (FootScan platform) 1
Time Frame: 2 times - immediately before and after 3000 m run
During dynamic measurement participants were asked to walk barefoot in a relaxed manner at a self-selected comfort speed, and not to look at the ground. Dynamic parametrers include foot pressure (impulse - Ns/cm).
2 times - immediately before and after 3000 m run
Dynamic foot analysis (FootScan platform) 2
Time Frame: 2 times - immediately before and after 3000 m run
During dynamic measurement participants were asked to walk barefoot in a relaxed manner at a self-selected comfort speed, and not to look at the ground. Dynamic parametrers include gait speed (m/s).
2 times - immediately before and after 3000 m run
Dynamic foot analysis (FootScan platform) 3
Time Frame: 2 times - immediately before and after 3000 m run
During dynamic measurement participants were asked to walk barefoot in a relaxed manner at a self-selected comfort speed, and not to look at the ground. Dynamic parametrers include walking time (s).
2 times - immediately before and after 3000 m run

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gdansk University of Physical Education and Sport

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Paulina W Ewertowska, PhD, Gdansk University of Physical Education and Sport

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 22, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AWFiS/2023_6_PE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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