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History of Changes for Study: NCT00510523
Whole Body Vibration Therapy in Participants With MS Related Balance Deficits
Latest version (submitted May 2, 2013) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 1, 2007 None (earliest Version on record)
2 May 2, 2013 Recruitment Status, Study Status, Contacts/Locations and Sponsor/Collaborators
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Study NCT00510523
Submitted Date:  August 1, 2007 (v1)

Open or close this module Study Identification
Unique Protocol ID: RD0731060030
Brief Title: Whole Body Vibration Therapy in Participants With MS Related Balance Deficits
Official Title: Whole Body Vibration Therapy in Participants With MS Related Balance Deficits
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2007
Overall Status: Recruiting
Study Start: October 2006
Primary Completion:
Study Completion: November 2007
First Submitted: July 31, 2007
First Submitted that
Met QC Criteria:
August 1, 2007
First Posted: August 2, 2007 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 1, 2007
Last Update Posted: August 2, 2007 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Logan College of Chiropractic
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: The purpose of this investigation is to determine the effect of Whole Body Vibration Therapy (WBV) on balance in participants with multiple sclerosis (MS) related balance deficits as measured by the NeuroCom Balance Master, the Sapphire IIME EMG Device and the Kurtzke Expanded Disability Status Scale (EDSS) and the Berg Balance Score.
Detailed Description:
Open or close this module Conditions
Conditions: Multiple Sclerosis
Keywords: MS
Balance
Multiple Sclerosis
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Crossover Assignment
Number of Arms:
Masking: Single (masked role unspecified)
Allocation: Randomized
Enrollment: 80 [Anticipated]
Open or close this module Arms and Interventions
Intervention Details:
Device: Whole Body Vibration machine
Open or close this module Outcome Measures
Primary Outcome Measures:
1. NeuroCom Balance Master
2. SF-EMG Nerve conduction velocity test
3. Berg balance score
Open or close this module Eligibility
Minimum Age: 25 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Logan student, staff, or faculty or general public with a minimal of 2 year history of diagnosed Multiple Sclerosis (MS)

Exclusion Criteria:

  • Visual or vestibular condition that would affect balance
  • Non-Ms related systemic illness that would have an adverse effect on balance
  • 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 48 hours
  • Acute disc herniation, discopathy or spondylolysis
  • Prescription or herbal muscle stimulants, relaxants, etc. that could affect balance
  • Any implanted device or prosthesis or intrauterine IUD type of device
  • Pregnancy
Open or close this module Contacts/Locations
Central Contact Person: Dennis Enix, DC, MBA
Telephone: 636-227-2100 Ext. 1951
Email: dennis.enix@logan.edu
Study Officials: Dennis Enix, DC, MBA
Principal Investigator
Logan College of Chiropractic
Dennis Enix, DC, MBA
Principal Investigator
Logan University
Locations: United States, Missouri
Logan University, College of Chiropractic
[Recruiting]
Chesterfield, Missouri, United States, 63017
Contact:Contact: Dennis E. Enix, DC 636-227-2100 Ext. 1951 dennis.enix@logan.edu
Contact:Principal Investigator: Dennis E. Enix, DC
Logan University, College of Chirpractic
[Recruiting]
Chesterfield, Missouri, United States, 63017
Contact:Contact: LaShandra M Cheuvront, BA 636-230-1952 lashandra.cheuvront@logan.edu
Contact:Principal Investigator: Dennis Enix, DC
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: Romberg A, Virtanen A, Ruutiainen J, Aunola S, Karppi SL, Vaara M, Surakka J, Pohjolainen T, Seppanen A. Effects of a 6-month exercise program on patients with multiple sclerosis: a randomized study. Neurology. 2004 Dec 14;63(11):2034-8. doi: 10.1212/01.wnl.0000145761.38400.65. PubMed 15596746
Griffin JW. Use of proprioceptive stimuli in therapeutic exercise. Phys Ther. 1974 Oct;54(10):1072-9. doi: 10.1093/ptj/54.10.1072. No abstract available. PubMed 4422763
Links:
Available IPD/Information:

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