NCT00610298

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 7, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

8.2 years

First QC Date

December 26, 2007

Last Update Submit

September 12, 2016

Conditions

Neuromuscular DeficitsMusculoskeletal Deficits

Keywords

disability affecting strength, balance and coordination

Outcome Measures

Primary Outcomes (1)

  • Berg Balance Test

    begining and end of intervention

Secondary Outcomes (2)

  • Sit to stand test

    begining and end of intervention

  • timed walking test

    begining and end of intervention

Study Arms (2)

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

whole body vibration using a Galileo vibrating platformDEVICE

whole body vibration at 20 hertz for 3 minutes 3 to 5 days per week for up to 12 weeks

I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Study Officials

  • Velimir Matkovic, M.D., Ph.D.

    Ohio State University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Manager for Matkovic

Study Record Dates

First Submitted

December 26, 2007

First Posted

February 7, 2008

Study Start

October 1, 2001

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

September 14, 2016

Record last verified: 2016-09

Locations

US(1)