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

Phase 1

• Conditions: Spinal Cord Injury
• Interventions: Procedure: Vibration Therapy

• Registration Number: NCT00624988
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-19
• Study First Submitted QC: 2008-02-19
• Study First Posted: 2008-02-28
• Study Start: 2008-07
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-16
• Last Update Posted: 2008-10-17
• Primary Completion: 2009-02
• Study Completion: 2009-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vibration Therapy	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

Name	Time	Method
Bone density scan	within 7 days pre/post intervention

Secondary Outcome Measures

Name	Time	Method
Single fiber EMG at neuromuscular junction	7 days pre/post intervention

Trial Locations

Locations (1)

Logan College of Chiropractic; 🇺🇸 Chesterfield, Missouri, United States