The Effect of Vibration Therapy on the Bone Density of th... | NCT00624988

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

NCT00624988

Sponsor

Logan College of Chiropractic

Status

Unknown status

Last Update Posted

Oct 17, 2008Estimated

Enrollment

10Estimated

Phase

Phase 1Phase 2

Conditions

Spinal Cord Injury

Interventions

Vibration Therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Feb 2009Estimated

Completion Date

Feb 2009Estimated

First Submitted Date

Feb 19, 2008

First Submission Date that Met QC Criteria

Feb 19, 2008

First Posted Date

Feb 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2008

Last Update Posted Date

Oct 17, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vibration Therapy	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vibration Therapy	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.

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

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

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
David V Lenihan, DC, PhD	Contact	(314) 614-5005		davidvlenihan@hotmail.com

Overall Officials

Name	Affiliation	Role
David V Lenihan, DC, PhD	Logan College of Chiropractic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Logan College of Chiropractic	Not yet recruiting	Chesterfield	Missouri	63006	United States

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided