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The Effect of Whole Body Vibration on Spasticity in Persons With Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02127606
Recruitment Status : Unknown
Verified November 2014 by Kessler Foundation.
Recruitment status was:  Recruiting
First Posted : April 30, 2014
Last Update Posted : November 26, 2014
Sponsor:
Information provided by (Responsible Party):
Kessler Foundation

Study Description
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Brief Summary:
Extended periods of tilt table standing have been observed to improve spasticity in individuals with spinal cord injury (SCI). The purpose of this study is to determine the effect of three sessions of whole body vibration while tilt table standing on spasticity in individuals with a complete or incomplete SCI above the neurological level of T10. Participants in this study will undergo whole body vibration while standing on a tilt table for a total of approximately 14 minutes for a total of 3 sessions on 3 separate days. Spasticity monitoring will be evaluated prior to and after the intervention with the Modified Penn Spasm Frequency Scale, an interview to obtain the individual's perception and impression of the effect of whole body vibration on the performance of activities of daily living, quality of life, pain scale, and global impression of change.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Spasticity Device: Vibration with tilt-table standing Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Whole Body Vibration on Spasticity in Spinal Cord Injury Patients
Study Start Date : April 2014
Estimated Primary Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Vibration with tilt-table standing
Participants in this arm will undergo alternating side-to-side, whole body vibration while standing on a tilt table for multiple treatments for a total of approximately 14 minutes for 3 sessions over 3 different days
 Device: Vibration with tilt-table standing
Other Names:
  • Galileo Tilt-Table
  • Galileo System
  • Vibrating platform
  • Whole-body vibration with tilt-table standing


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) score after the third treatment [ Time Frame: Participants will be followed for the duration of the 3 treatments, an expected average of 1 week ]

Secondary Outcome Measures :
  1. Change from Baseline in the Pain Severity Numerical Rating Scale (NRS) score after the third treatment [ Time Frame: Participants will be followed for the duration of the 3 treatments, an expected average of 1 week ]
  2. Change from Baseline in the Penn Spasm Frequency Scale score after the third treatment [ Time Frame: Participants will be followed for the duration of the 3 treatments, an expected average of 1 week ]

Other Outcome Measures:
  1. Subject Global Impression of Change (SGIC) [ Time Frame: After the third treatment, an expected average of 1 week ]
  2. Adverse Events [ Time Frame: Participants will be followed for the duration of the 3 treatments, an expected average of 1 week ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject is male or female, 18 to 70 years of age, inclusive.
  • The subject has neurological impairment secondary to a spinal cord injury that occurred at least six (6) months prior to the study that can be categorized as either a complete or incomplete spinal cord injury.
  • The neurological level of lesion is above T10.
  • The subject has self-reported stable moderate to severe spasticity (Modified Ashworth Score scale at or greater than a 2 at the hips or knees). Patients can be enrolled if on a stable dose of oral medications or intrathecal medications.
  • The subject has self reported spasticity that negatively impacts his or her quality of life, impairs ability to perform activities of daily living (such as transfers, sitting, sleep, wheelchair use, and hobbies).
  • The subject is able to stand with the assistance of a tilt table at a minimum of 70 degrees for 45 minutes without significant orthostasis or other adverse events or symptoms.
  • The subject is able and willing to comply with the protocol.
  • The subject is able to and has voluntarily given informed consent prior to the performance of any study-specific procedures.

Exclusion Criteria:

  • The subject does not self report lower limb spasticity.
  • The subject does not have self reported spasticity that negatively impacts his or her quality of life, impairs ability to perform activities of daily living (such as transfers, sitting, sleep, wheelchair use, and hobbies).
  • The subject experiences symptoms consistent with infection, including but not limited to fever, chills, dysuria, gallbladder or kidney stones.
  • The subject experiences pain that is not well controlled with consistent pain medication use.
  • The subject has recent thromboembolism, diabetes mellitus, intractable hypertension or cardiac/pulmonary instability, internal fixation implants, acute thrombosis, pregnancy, acute inflammation of the locomotor system including active arthrosis or arthropathy, acute tendinopathy, acute hernia, acute discopathy, recent post-surgical wounds, epilepsy, rheumatoid arthritis, or recent fractures<6 months.
  • The subject has a lumbar spinal hardware or artificial joints in the lower extremities.
  • The subject is participating in any experimental studies that could alter the patient's spasticity.
  • The subject has a concomitant brain injury or other cognitive deficits that would preclude following instructions.
  • The subject has skin breakdown in areas receiving direct pressure during tilt table standing.
  • The subject has any medical condition, including psychiatric disease that would interfere with the interpretation of the study results or the conduct of the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02127606


Contacts
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Contact: Trevor A. Dyson-Hudson, M.D. 973-324-3576 tdysonhudson@kesslerfoundation.org
Contact: Steven C. Kirshblum, M.D. 800-248-3221 ext 2258 skirshblum@kessler-rehab.com

Locations
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United States, New Jersey
Kessler Institute for Rehabilitation Recruiting
West Orange, New Jersey, United States, 07052
Contact: Trevor A. Dyson-Hudson, M.D.    973-324-3576    tdysonhudson@kesslerfoundation.org   
Contact: Matthew Weiner    973-324-3515    mweiner@kesslerfoundation.org   
Principal Investigator: Steven C. Kirshblum, M.D.         
Sub-Investigator: Trevor A. Dyson-Hudson, M.D.         
Sub-Investigator: Alice Hon, M.D.         
Sponsors and Collaborators
Kessler Foundation
Investigators
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Principal Investigator: Steven C. Kirshblum, M.D. Kessler Institute for Rehabilitation
Principal Investigator: Trevor A. Dyson-Hudson, M.D. Kessler Foundation
More Information
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Responsible Party: Kessler Foundation
ClinicalTrials.gov Identifier: NCT02127606    
Other Study ID Numbers: R-811-14
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: November 26, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Muscle Spasticity
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
 Trauma, Nervous System
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations