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

October 16, 2008 updated by: Logan College of Chiropractic
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Recruiting
        • Logan College of Chiropractic
        • Contact:
      • Chesterfield, Missouri, United States, 63006
        • Not yet recruiting
        • Logan College of Chiropractic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bone density scan
Time Frame: within 7 days pre/post intervention
within 7 days pre/post intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Single fiber EMG at neuromuscular junction
Time Frame: 7 days pre/post intervention
7 days pre/post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Logan College of Chiropractic

Investigators

  • Principal Investigator: David V Lenihan, DC, PhD, Logan College of Chiropractic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ANTICIPATED)

February 1, 2009

Study Completion (ANTICIPATED)

February 1, 2009

Study Registration Dates

First Submitted

February 19, 2008

First Submitted That Met QC Criteria

February 19, 2008

First Posted (ESTIMATE)

February 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 17, 2008

Last Update Submitted That Met QC Criteria

October 16, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD0723070100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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