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

NCT ID: NCT00624988

Last Updated: 2008-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-02-28

Brief Summary

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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

Detailed Description

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Conditions

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Spinal Cord Injury

Keywords

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Spinal cord injury vibration therapy bone density

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Vibration Therapy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Logan College of Chiropractic

OTHER

Sponsor Role lead

Responsible Party

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Logan University, College of Chiropractic

Principal Investigators

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David V Lenihan, DC, PhD

Role: PRINCIPAL_INVESTIGATOR

Logan College of Chiropractic

Locations

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Logan College of Chiropractic

Chesterfield, Missouri, United States

Site Status NOT_YET_RECRUITING

Logan College of Chiropractic

Chesterfield, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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David V Lenihan, DC, PhD

Role: CONTACT

Phone: (314) 614-5005

Email: [email protected]

Facility Contacts

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Dennis Enix, DC, MBA

Role: primary

Other Identifiers

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RD0723070100

Identifier Type: -

Identifier Source: org_study_id