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Use of Whole-Body Periodic Acceleration Therapy To Aches and Pains (Exer-Rest)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Center for Translational Medicine.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Center for Translational Medicine Identifier:
First received: June 26, 2012
Last updated: June 27, 2012
Last verified: June 2012
The purpose of this study is to test the effectiveness of whole body periodic acceleration for helping with symptoms of aches and pains suffered by many patients.

Condition Intervention Phase
Pain Stiffness Abnormal Gait Balance Device: Whole body periodic acceleration (Exer-Rest) Phase 3

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Unblinded Crossover Study of The Use of Whole-Body Periodic Acceleration Therapy To Treat Pain, Stiffness, Abnormal Gait and Balance

Further study details as provided by Center for Translational Medicine:

Primary Outcome Measures:
  • Self-report of pain [ Time Frame: 2 weeks ]
    Self-report of pain at start and completion of first course of treatment lasting for 2 weeks.

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 2 weeks ]
    Self-report of change in quality following 2 weeks of treatment.

Estimated Enrollment: 30
Study Start Date: August 2011
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Whole body periodic acceleration (Exer-Rest)
    Lying on the vibrating bed for 45 minutes per session for 10 sessions over 2 weeks.
Detailed Description:
This is an unblinded cross-over study of whole-body periodic acceleration (WBPA) to ascertain if this treatment modality provides symptomatic relief of pain, stiffness, and abnormal gait and balance in a variety of conditions. The study will compare a specific mechanism of motion, whole-body periodic acceleration (WBPA), that has been shown to increase the release of beneficial mediators from the vascular endothelium into the circulation, to a control condition of slow passive motion that promotes relaxation but does not increase release of beneficial mediators into the circulation. The study tests the efficacy and safety of a commercially available device that consists of a motion platform, called Exer-Rest©, that is capable of producing both types of motion to be tested. In this investigation, 15 subjects will be randomly assigned to either procedure for 10 treatments for 2 weeks followed by a one-week "wash-out" period. Then the opposite treatment will be employed for two weeks.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Subjects qualifying for this study satisfy the following criteria:

  1. Over 18 years of age;
  2. Complain of either chronic pain, joint stiffness, and/or dysfunctions of gait and balance;
  3. Complaints have been annotated by a competent physician, and the subject has been evaluated for conditions that commonly contribute to the respective symptoms;
  4. Capable of completing the appropriate testing and baseline assessments, such as quantitative electroencephalography (qEEG) and questionnaires;
  5. Tolerate the motion and duration of treatment of the WBPA.
  6. Be available for regular visits to the research site for the duration of the study.

Exclusion Criteria:

WBPA is contraindicated for subjects who are pregnant or who suffer with unexplained leg pain, skin eruptions, or who have unstable spinal injuries or conditions. Subjects who cannot tolerate the motion and duration of treatment are also excluded.

  Contacts and Locations
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Please refer to this study by its identifier: NCT01629810

United States, Maryland
Translational Medicine Group Recruiting
Bethesda, Maryland, United States, 20852
Contact: Karen P Walters, MSN    240-221-0000   
Principal Investigator: Stephen N Xenakis, M.D.         
Sponsors and Collaborators
Center for Translational Medicine
  More Information

Responsible Party: Center for Translational Medicine Identifier: NCT01629810     History of Changes
Other Study ID Numbers: 20110957
Study First Received: June 26, 2012
Last Updated: June 27, 2012

Keywords provided by Center for Translational Medicine:
Motion platform at appropriate settings.
Relief of pain.
Improvement in quality of life, cognition, and mood.
Effects of WBPA on cognition, mood, behavior, and functioning.
Dose response effect .
Gather data for long-term (2 year) study processed this record on August 22, 2017