Clinical Trials Directory

Trials / Completed

CompletedNCT01430858

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
5 (actual)
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust · Academic / Other
Sex
All
Age
18 Years – 50 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DEVICEStrain GaugeThe 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.
OTHERVibration therapyGalileo 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.

Timeline

Start date
2011-03-01
Primary completion
2012-12-01
Completion
2012-12-01
First posted
2011-09-08
Last updated
2019-02-15

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT01430858. Inclusion in this directory is not an endorsement.