Effects of Whole Body Vibration in Elderly Patients Requi... | NCT00610298

Studies
Effects of Whole Body Vibration in Elderly Patients Requiring Rehabilitation: A Pilot Study

NCT00610298

Sponsor

Ohio State University

Status

Withdrawn

Last Update Posted

Sep 14, 2016Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Neuromuscular Deficits
Musculoskeletal Deficits

Interventions

whole body vibration using a Galileo vibrating platform

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

Sep 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Another institution conducted and published this study.No subjects enrolled.

Expanded Access Info

Start Date

Oct 2001

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Dec 26, 2007

First Submission Date that Met QC Criteria

Feb 6, 2008

First Posted Date

Feb 7, 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

Sep 12, 2016

Last Update Posted Date

Sep 14, 2016Estimated

Name	Class
Velimir Matkovic	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

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 aim of this study is to accumulate data about the influence of whole body vibration on the functional recovery of adult patients with various neuromuscular and musculoskeletal deficits requiring physical medicine and rehabilitation treatments.

Detailed Description

We know that whole body vibration can cause remarkable increase in power in athletes, however, to what extent elderly and disabled individuals could benefit from it is currently unknown. Our primary goal is to investigate if treatment with whole body vibration in elderly persons and patients with various neuromuscular and musculoskeletal deficits would result in more rapid return of their function and presumably at a higher level than comparable group of patients undergoing standard physical therapy.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I	Experimental	Subjects who receive whole body vibration	Device: whole body vibration using a Galileo vibrating platform
N	No Intervention	Subjects do not receive whole body vibration intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
whole body vibration using a Galileo vibrating platform	Device	whole body vibration at 20 hertz for 3 minutes 3 to 5 days per week for up to 12 weeks	I

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Berg Balance Test		begining and end of intervention

Secondary Outcomes

Measure	Description	Time Frame
Sit to stand test		begining and end of intervention
timed walking test		begining and end of intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A history of one of the following conditions: CVA, Parkinson's disease, incomplete spinal cord injury, frail elderly, urinary incontinence, COPD, fibromyalgia
Patients with neuromusculoskeletal problems affecting strength, balance, and coordination
Must have all appendages (arms and legs) intact, not an amputee

Exclusion Criteria:

Pregnancy
Unable o participate in continuing outpatient therapy services at a location where the whole body vibration equipment is available
Untreated deep venous thrombosis
Other condition that will lead to poor treatment adherence
History of join replacement of lower limbs, shoulders, or devices in the spine

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

Not provided

Overall Officials

Name	Affiliation	Role
Velimir Matkovic, M.D., Ph.D.	Ohio State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Ohio State University		Columbus	Ohio	43210	United States