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

NCT ID: NCT01430858

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-12-31

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.

Conditions

Osteoporosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Strain Gauge

Intervention Type: 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.

Vibration therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

Rosette strain gauge (FRA-2-11 Tokyo Sokki Kenkyujo Co., Japan); Galileo 900 platform (Novotec Medical GmbH, Medical device CE0123); Juvent 1000 platform (CE-marked); Power Plate Pro5 (CE-marked)

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
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sheffield

OTHER

Sponsor Role: collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eugene McCloskey, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Sheffield

Locations

Academic Unit of Bone Metabolism

Sheffield, South Yorks, United Kingdom

Countries

United Kingdom

Other Identifiers

STH15516

Identifier Type: -

Identifier Source: org_study_id