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

Study Overview
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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

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

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Procedure: Vibration Therapy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vibration Therapy<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone density scan |  | within 7 days pre/post intervention | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal cord injury, vibration therapy, bone density