Does Vibration Therapy Induce Higher Than Normal Bone Strains and Strain Rates Than Those Experienced During Habitual Daily Activities
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|ClinicalTrials.gov Identifier: NCT01430858|
Recruitment Status : Unknown
Verified December 2012 by Sheffield Teaching Hospitals NHS Foundation Trust.
Recruitment status was: Recruiting
First Posted : September 8, 2011
Last Update Posted : December 17, 2012
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:
Determine the relationship between tibial bone strain and
- the frequency and amplitude of vibration therapy
- a range of habitual locomotor activities;
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;
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis||Device: Strain Gauge Other: Vibration therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Measurement of Induced Strains in the Human Tibia During Vibration Therapy and Habitual Activities|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||July 2013|
|Estimated Study Completion Date :||July 2013|
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 Name: 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.
- 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 ]
- 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 ]
- 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 ]
- 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)
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01430858
|Contact: Eugene McCloskey, Professor||0114 2714705||E.V.McCloskey@sheffield.ac.uk|
|Contact: Tracey S Higginbottom||01142715238 ext 15238||Tracey.Higginbottom@sth.nhs.uk|
|Academic Unit of Bone Metabolism||Recruiting|
|Sheffield, South Yorks, United Kingdom, S5 7AU|
|Contact: Eugene McCloskey, Professor 0114 2714705 email@example.com|
|Contact: Tracey S Higginbottom 01142715238 ext 15238 Tracey.Higginbottom@sth.nhs.uk|
|Principal Investigator: Eugene McCloskey, Professor|
|Principal Investigator:||Eugene McCloskey, Professor||University of Sheffield|