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

NCT01430858 | Completed

• 1 other identifier: STH15516
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

Osteoporosis

Keywords

Fracture; Anabolic; Vibration; Strain Gauge; Focus - Osteoporosis

Outcome Measures

Primary Outcomes (2)

• 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

  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

  At time of Vibration Therapy

Secondary Outcomes (3)

• 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 Arms (1)

Strain Gauge

OTHER

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; Other: Vibration therapy

Interventions

Strain Gauge DEVICE

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.

Also known as: Rosette strain gauge (FRA-2-11 Tokyo Sokki Kenkyujo Co., Japan)

Strain Gauge

Vibration therapy OTHER

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.

Also known as: Galileo 900 platform (Novotec Medical GmbH, Medical device CE0123), Juvent 1000 platform (CE-marked), Power Plate Pro5 (CE-marked)

Strain Gauge

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• University of Sheffield: collaborator

Study Sites (1)

Academic Unit of Bone Metabolism

Sheffield, South Yorks, S5 7AU, United Kingdom

Location

MeSH Terms

Conditions

Osteoporosis; Fractures, Bone

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries

Study Officials

• Eugene McCloskey, Professor

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2011
• First Posted: September 8, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

GB (1)