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Effects Of Unilateral Forearm Vibration On The Loss Of Muscle And Bone Of Contralateral Forearm (Vib-Frx)

This study is not yet open for participant recruitment.
Verified January 2013 by Bagcilar Training and Research Hospital
Sponsor:
Information provided by (Responsible Party):
Karacan, Bagcilar Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT01553487
First received: March 5, 2012
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

The aim of the present study is to investigate the effects of vibrating the forearm bone in the free limb on muscle strength and bone mineral density of the forearm in patients with forearm/elbow fracture.

A total of 80 patients with forearm/elbow fracture are planned to include in this study. Patients will be randomly attained Training or Control group. Training period will be six weeks. Patients in the control group will receive standard care for provided for fractures, including fixation and rest.Before the start of the study and after six weeks, bilateral bone density of distal radius will be measured by DXA. Before trials, grip strength and the rest muscle electrical activity of contralateral wrist flexors and extensors will be measured. After six weeks, bilateral grip strength and the rest muscle electrical activity will be measured.


Condition Intervention
Effects of Vibration
 Other: Forearm vibration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects Of Unilateral Forearm Vibration On The Loss Of Muscle Strength And Bone Of The Contralateral Forearm Due to Forearm/Elbow Fracture

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bagcilar Training and Research Hospital:

Primary Outcome Measures:
  • Change of forearm muscle strength [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
    Change of muscle strength with forearm vibration


Secondary Outcome Measures:
  • Change of distal radius bone mineral density [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
    Change of distal radius bone mineral density with forearm vibration


Estimated Enrollment: 80
Study Start Date: September 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Excercise
The forearm vibration training
 Other: Forearm vibration
All cases will be trained by forearm vibration device 5 times a week for six weeks period.
Other Name: vibration training
No Intervention: Control
Patients will be treated by routine fracture treatment methods (fixation and rest).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a simple (uncomplicated) forearm/elbow fracture
  • Males and females between 18 and 50 years of age

Exclusion Criteria:

  • Fracture of distal radius
  • Multiple previous fractures of bones in the upper extremities
  • Complicated fracture (associated skin and/or tendon and/or nerve and/or vascular trauma, fragmented fractures )
  • Patients not examined within the first three days after a trauma

  • Upper extremity problems

    • Orthopedic problems: shortness of arms, congenital abnormalities
    • Joint disease (arthritis, joint prosthesis, etc.)
    • Other painful pathologies in the upper extremities (tendinitis, bursitis, etc.)
    • Circulation problems in the upper extremities
    • Skin lesions, dermatologic disorders
  • Hypertension (>135 mmHg systolic, >85 mmHg diastolic) or Heart disease (coronary dis, conduction/rhythm prob, cardiac pacemaker)
  • Neurological diseases (CNS problems, peripheral neuropathy)
  • Systemic disease affecting bone metabolism: secondary osteoporosis, osteomalacia, Paget's disease, Diabetes mellitus, hepatic disease, renal dis. etc
  • Non-cooperative patients, psychiatric conditions (panic attacks etc)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01553487

Contacts
Contact: ILHAN KARACAN, MD +902124404000 ext 1517 ilhankaracan@hotmail.com

Locations
Turkey
Bagcilar Training & Research Hospital Not yet recruiting
Istanbul, Turkey
Contact: ILHAN KARACAN, MD     902124404000 ext 1517     ilhankaracan@hotmail.com    
Principal Investigator: MUHARREM CIDEM, MD            
Sponsors and Collaborators
Bagcilar Training and Research Hospital
Investigators
Study Chair: ILHAN KARACAN, MD Bagcilar Training & Research Hospital
  More Information

No publications provided

Responsible Party: Karacan, Clinical Associated Professor, Bagcilar Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01553487     History of Changes
Other Study ID Numbers: BEAH FTR-6
Study First Received: March 5, 2012
Last Updated: January 29, 2013
Health Authority: Turkey: Ministry of Health

Keywords provided by Bagcilar Training and Research Hospital:
vibration
muscle strength
bone loss
immobilization
fracture

Additional relevant MeSH terms:
Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013