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Clinical Trials/NCT01430858
NCT01430858
Completed
Not Applicable

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

Sheffield Teaching Hospitals NHS Foundation Trust1 site in 1 country5 target enrollmentMarch 2011
ConditionsOsteoporosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoporosis
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Enrollment
5
Locations
1
Primary Endpoint
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
Status
Completed
Last Updated
7 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
December 2012
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

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
  • History of cancer within the previous 5 years

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)(At time of Vibration Therapy)
  • Peak amplitude attenuation and phase shift of the oscillating positional coordinates and accelerations(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(At time of Vibration Therapy)

Study Sites (1)

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