Does Vibration Therapy Induce Higher Than Normal Bone Strains and Strain Rates Than Those Experienced During Habitual Daily Activities

February 12, 2019 updated by: Sheffield Teaching Hospitals NHS Foundation Trust

Measurement of Induced Strains in the Human Tibia During Vibration Therapy and Habitual Activities

The overall aim of this study is to test the hypothesis that vibration exercise can induce higher than normal bone strains and strain rates than are experienced during habitual locomotor activities.

The investigators plan to study healthy young volunteers to:

  1. Determine the relationship between tibial bone strain and

    • the frequency and amplitude of vibration therapy
    • a range of habitual locomotor activities;

  2. Determine the transmission of vibrations during vibration therapy, in terms of

    • amplitude attenuation and phase shift of positional coordinates and accelerations at anatomic landmarks along the lower leg and other skeletal sites
    • the relationship between these and different frequencies and amplitudes of vibration therapy;
  3. Determine the muscle power in the lower limb associated with various habitual locomotor activities and its relationship to the measured tibial bone strain.

The investigators subsequently hope to use the data captured in this experiment to develop a QCT-based finite element (FE) model of the human lower limb (tibia, fibula and foot). The investigators will then validate this model in relation to the characteristics (amplitude and phase shift) of the measured tibial bone strain and transmission of vibrations to the different anatomical landmarks during vibration therapy.

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.
5

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

  • United Kingdom
    • South Yorks
      • Sheffield, South Yorks, United Kingdom, S5 7AU
        • Academic Unit of Bone Metabolism

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female volunteers, ages 18 to 50 years
  • Generally healthy, as determined by review of medical history and physical exam
  • Ambulatory
  • Willing and physically able to undergo all study procedures
  • BMD (measured by DXA) at the lumbar spine and hip within ± 2 SD of the young normal range
  • BMI < 30

Exclusion Criteria:

  • Previous diagnosis of osteoporosis
  • History of fracture of the spine, pelvis, leg or foot
  • History of bone or joint disorders affecting the shoulders, spine, pelvis, legs or feet (e.g. arthritis, congenital hip dislocation, spinal spondylolisthesis)
  • Ongoing conditions or diseases known to cause secondary osteoporosis
  • Malabsorption syndromes (e.g. coeliac or Crohn's disease)
  • Known disorders of calcium metabolism
  • Known history of thyroid disease
  • Osteomalacia
  • Paget's disease
  • Diabetes
  • History of cancer within the previous 5 years
  • Epilepsy
  • Ongoing conditions or use of medications that may impair vision or balance

  • Use of the following medications within the previous 2 years

    • Bisphosphonates
    • Fluoride (except use for oral hygiene)
    • Strontium
    • Teriparatide
    • Other bone agents (e.g. SERMs, isoflavones, HRT, calcitonin etc)
    • Steroids
  • Alcohol abuse or illicit drug use
  • Pregnancy or currently trying to conceive (women only)
  • Inability to give informed consent
  • Known hypersensitivity to the antibiotic penicillin or cephalosporins
  • Known hypersensitivity to the local anaesthetic lignocaine.

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: Other
  • 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.
Other: Strain Gauge
We wish to determine the relationship between tibial bone strain (recorded from implanted tibial strain gauges) and measured displacements of the limb and pelvis (using video motion analysis) during vibration exercise and a range of habitual locomotor activities. Only healthy volunteers will be recruited to this one arm.
Device: Strain Gauge
The study participants will each undergo sterile surgical implantation of a tibial bone strain gauge in the right leg (dominance will recorded and determined by handedness). A single stacked, 45°, rosette strain gauge (FRA-2-11 Tokyo Sokki Kenkyujo Co., Japan) will be unilaterally bonded to the medial tibial cortex and carefully aligned with the long axis of the tibia. The gauge will be attached at the mid-shaft region, to determine the transmission of the vibrations through the bone and quantification of the microstructural effect.
Other Names:
  • Rosette strain gauge (FRA-2-11 Tokyo Sokki Kenkyujo Co., Japan)
Other: Vibration therapy

Galileo 900 platform. Study subjects will be asked to stand on the device for a series of 36 tests, with vibrations applied at various frequencies and amplitudes. A 20-second duration of videomotion & strain gauge readings will be captured.

Juvent 1000 platform The volunteers will stand on the platform for one minute during which a 20-second duration of videomotion & strain gauge readings will be captured.

Power Plate Pro5 Two amplitude settings will be tested, described as low & high. The subject will stand on each platform test for up to 1 minute, during which a 20-second duration of videomotion & strain gauge readings will be captured.

Other Names:
  • Galileo 900 platform (Novotec Medical GmbH, Medical device CE0123)
  • Juvent 1000 platform (CE-marked)
  • Power Plate Pro5 (CE-marked)

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
Time Frame
Maximum amplitudes of the vibrating principal strain, and maximum shear strain, γv (microstrain) of the tibial bone calculated from the tibial bone strains recorded during vibration therapy
Time Frame: At time of Vibration Therapy
At time of Vibration Therapy
Maximum principal strain εh and maximum shear strain γh (microstrain) of the tibial bone calculated from the tibial bone strains recorded during habitual locomotor activities
Time Frame: At time of Vibration Therapy
At time of Vibration Therapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Peak amplitude attenuation αv (in cm and percentage) and phase shift βv (in degrees) of the tibial strain primary endpoints εv and γv as a function of vibration frequency and amplitude (using the vibration device as a reference)
Time Frame: At time of Vibration Therapy
At time of Vibration Therapy
Peak amplitude attenuation and phase shift of the oscillating positional coordinates and accelerations
Time Frame: At time of Vibration Therapy
Peak amplitude attenuation αm (in cm and percentage) and phase shift βm (in degrees) of the oscillating positional coordinates and accelerations (at different anatomical landmarks) measured by VICON MX motion analysis system during vibration therapy (using the vibration device as a reference)
At time of Vibration Therapy
Posture during vibration therapy assessed in terms of the angulations of the ankle, knee and hip joints and of the trunk, derived from the positional coordinates
Time Frame: At time of Vibration Therapy
At time of Vibration Therapy

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.
Sheffield Teaching Hospitals NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Sheffield

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.
  • Principal Investigator: Eugene McCloskey, Professor, University of Sheffield

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

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.
March 1, 2011

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 1, 2012

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 1, 2012

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).
September 7, 2011

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.
September 7, 2011

First Posted (Estimate)

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.
September 8, 2011

Study Record Updates

Last Update Posted (Actual)

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.
February 15, 2019

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.
February 12, 2019

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.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • STH15516

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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