NCT01097122

Brief Summary

This study hypothesize that radius subjecting to mechanical loading may affect excitability of alpha motor neuron innervating muscle, based on its bone mineral density or bone mineral content. A total of 80 voluntaries are planned to include in this study. Vibration will be applied the right forearm. Muscle electrical activity will be measured on ipsilateral and contralateral flexor carpi radialis (FCR) muscle at rest as EMGrms by surface electromyography (EMG). The rest-EMGrms will be measured at before and during vibration. An increase in muscle electrical activity at rest indicates an increase in motor neuron pool activation. The right distal radius bone mineral content (BMC) and density will be measured by dual energy X-ray absorptiometry (DXA). The right radius bone mineral density (BMD) and BMC will be evaluated by bone densitometer (GE-LUNAR DPX PRO). Motor unit potentials will be measured by electromyography at left flexor carpi radialis. Neurotrac ETS device will be used.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

February 27, 2012

Status Verified

February 1, 2012

Enrollment Period

3 months

First QC Date

March 27, 2010

Last Update Submit

February 24, 2012

Conditions

Keywords

bonemotor neuron excitabilityforearm vibrationmechanical loadingmuscle electrical activity

Outcome Measures

Primary Outcomes (1)

  • Changes in rest muscle electrical activity in the contralateral untrained flexor carpi radialis during the right forearm vibration

    Rest muscle electrical activity changes will be examined in the contralateral untrained flexor carpi radialis during the right forearm vibration

    2 or 3 weeks

Study Arms (1)

Healthy young adult subjects

EXPERIMENTAL

Forearm vibration will be applied in healthy young adult subjects

Procedure: Forearm vibration

Interventions

Mechanical loading with forearm vibration will be applied right radius in all groups

Also known as: Cyclic mechanical loading
Healthy young adult subjects

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects
  • Right handed
  • Young adult women and men

You may not qualify if:

  • secondary osteoporosis
  • neuropathy (central or peripheral)
  • myopathy
  • systemic diseases (arthritis, endocrine-metabolic diseases, bone diseases)
  • professional sportswoman/sportsman
  • subjects doing regular sports activities
  • tendinopathy
  • amputee, endoprosthesis, metal implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vakif Gureba Training & Research Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • ILHAN KARACAN, MD

    Vakif Gureba Training & Research Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ILHAN KARACAN

Study Record Dates

First Submitted

March 27, 2010

First Posted

April 1, 2010

Study Start

March 1, 2010

Primary Completion

June 1, 2010

Study Completion

July 1, 2010

Last Updated

February 27, 2012

Record last verified: 2012-02

Locations