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The Effect of Vibration Therapy on the Bone Density of the Tiba in Patients With Spinal Cord Injury (SCI)

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ClinicalTrials.gov Identifier: NCT00624988
Recruitment Status : Unknown
Verified October 2008 by Logan College of Chiropractic.
Recruitment status was:  Recruiting
First Posted : February 28, 2008
Last Update Posted : October 17, 2008
Sponsor:
Information provided by:
Logan College of Chiropractic

Brief Summary:
The purpose of this investigation is to determine the effect of lower limb vibration therapy on bone density in the tibia in patients with spinal cord injury. The second purpose is to assess the neuromuscular junction variability at the motor units of the tibialis anterior muscle after a sequence of lower limb vibration therapy

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Procedure: Vibration Therapy Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Vibration Therapy on the Bone Density of the Tiba in Patients With Spinal Cord Injury
Study Start Date : July 2008
Estimated Primary Completion Date : February 2009
Estimated Study Completion Date : February 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vibration Therapy
Treatment will consist of 10 sessions of 60 seconds each with one minute intervals in between at 50 Hz frequency three times per week for three months.
Procedure: Vibration Therapy
Treatment will consist of 10 sessions of 60 seconds each with one minute intervals in between at 50 Hz frequency three times per week for three months.




Primary Outcome Measures :
  1. Bone density scan [ Time Frame: within 7 days pre/post intervention ]

Secondary Outcome Measures :
  1. Single fiber EMG at neuromuscular junction [ Time Frame: 7 days pre/post intervention ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over the age of 18 years
  • A spinal cord injury patient with injury above T12
  • Injury below T4 to avoid respiratory complication.
  • An ASIA classification of A or B

Exclusion Criteria:

  • Non complicating organic factors such as heart disease, high blood pressure, stroke
  • Exercise where electrical therapy is used while the trial is being conducted
  • A bone density measure 3 times below normal mineralization levels as measured on the first bone density scan prior to entry in to the study
  • Surgical implants below the level of T12
  • Local infection, acute inflammation, injury, tumors or other malignancy, recent wounds, diabetes
  • Any unstable joints of the lower extremity, recent hip and knee joints or fitted hip or knee pins, bolts and/or plates
  • Acute thrombosis
  • Severe migraine, epilepsy
  • Serious cardiovascular disease, wearing a pacemaker
  • Any Spinal manipulation within one year of the study
  • Any implanted device or prosthesis or intrauterine IUD type of device pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00624988


Contacts
Contact: David V Lenihan, DC, PhD (314) 614-5005 davidvlenihan@hotmail.com

Locations
United States, Missouri
Logan College of Chiropractic Not yet recruiting
Chesterfield, Missouri, United States, 63006
Logan College of Chiropractic Recruiting
Chesterfield, Missouri, United States, 63017
Contact: Dennis Enix, DC, MBA    636-230-1951    dennis.enix@logan.edu   
Sponsors and Collaborators
Logan College of Chiropractic
Investigators
Principal Investigator: David V Lenihan, DC, PhD Logan College of Chiropractic

Responsible Party: David Lenihan BA., D.C., Ph.D., M.C.C., CBiol MiBiol, FRSM, Logan University, College of Chiropractic
ClinicalTrials.gov Identifier: NCT00624988     History of Changes
Other Study ID Numbers: RD0723070100
First Posted: February 28, 2008    Key Record Dates
Last Update Posted: October 17, 2008
Last Verified: October 2008

Keywords provided by Logan College of Chiropractic:
Spinal cord injury
vibration therapy
bone density

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System