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Dose-Response Effects of Whole Body Vibration on Spasticity and Walking in SCI (WBV)

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ClinicalTrials.gov Identifier: NCT02340910
Recruitment Status : Recruiting
First Posted : January 19, 2015
Last Update Posted : August 17, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Shepherd Center, Atlanta GA

Tracking Information
First Submitted Date  ICMJE January 9, 2015
First Posted Date  ICMJE January 19, 2015
Last Update Posted Date August 17, 2018
Actual Study Start Date  ICMJE January 2015
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
Spasticity Assessments [ Time Frame: Estimated 1 hour ]
Pendulum test, Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) Questionnaire, Electrophysiological testing (Soleus H-reflex)
Original Primary Outcome Measures  ICMJE
 (submitted: January 13, 2015)
  • Pendulum Test [ Time Frame: 15 minutes ]
    Change from Pre Test in Pendulum Test
  • Pendulum Test [ Time Frame: 45 minutes ]
    Change from Pre Test in Pendulum Test
Change History Complete list of historical versions of study NCT02340910 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2018)
  • Walking ability [ Time Frame: Estimated 30 minutes ]
    Walking speed, endurance and pattern will be assessed while wearing motion capture sensors
  • Strength [ Time Frame: Estimated 20 minutes ]
    5 times sit to stand assessment, testing of upper leg muscle strength using force measurements
  • Pain perception [ Time Frame: Estimated 20 minutes ]
    SCI Pain Basic Dataset Questionnaire
  • Upper Extremity Tests [ Time Frame: Estimated 5 minutes ]
    For participants who have a cervical level of injury, pinch strength will be measured using a hand-held device and the nine-hole peg test will be used to measure hand function.
  • Ankle Clonus Test/Foot [ Time Frame: Estimated 15 minutes ]
    Ankle spasticity will be measured using motion capture sensors to record ankle joint angles.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2015)
  • Walking Speed Test [ Time Frame: 15 minutes ]
    Change from Pre Test in Walking Speed Test
  • Walking Speed Test [ Time Frame: 45 minutes ]
    Change from Pre Test in Walking Speed Test
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose-Response Effects of Whole Body Vibration on Spasticity and Walking in SCI
Official Title  ICMJE Not Provided
Brief Summary This study will enroll people with SCI who have spasticity and some ability to walk. The goal is to understand if standing on a platform and receiving WBV results in decreased spasticity and improved walking ability. Published article is available (PMID: 29959653)
Detailed Description

Phase 1 of this study has been successfully completed. The results of Phase 1 indicate that a single session of WBV lasting for a total of 6 minutes (delivered in eight 45-sec bouts) at a high-frequency (50Hz) was associated with the largest decrease in spasticity (as measured by the pendulum test).

The goal for Phase 2 is to determine whether longer doses of WBV result in greater reductions in spasticity as well as improvements in walking ability. Two different doses of WBV, a short dose and a long dose, will be tested.

Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:
Masked allocation and intervention
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE
  • Procedure: Short Duration
    During each WBV repetition, subjects will stand on the vibration platform of the WBV device with knees slightly bent (approximately 30 degrees flexion). The subject will hold the handrails for balance and the WBV device will be turned on. The subject will receive a total of 6 minutes of WBV at a frequency of 50 Hz.
  • Procedure: Long Duration

    During each WBV repetition, subjects will stand on the vibration platform of the WBV device with knees slightly bent (approximately 30 degrees flexion). The subject will hold the handrails for balance and the WBV device will be turned on. The subject will receive a total of 12 minutes of WBV at a frequency of 50 Hz.

    Interventions will occur for 5 days a week for 4 weeks .

Study Arms
  • Experimental: Short duration
    Short Duration WBV consists of 8 45-sec bouts of 50Hz WBV followed by a 1-minute seated rest
    Intervention: Procedure: Short Duration
  • Experimental: Long duration
    Long Duration WBV consists of 16 bouts 45-sec of 50Hz WBV followed by a 1-minute seated rest
    Intervention: Procedure: Long Duration
Publications * Estes S, Iddings JA, Ray S, Kirk-Sanchez NJ, Field-Fote EC. Comparison of Single-Session Dose Response Effects of Whole Body Vibration on Spasticity and Walking Speed in Persons with Spinal Cord Injury. Neurotherapeutics. 2018 Jul;15(3):684-696. doi: 10.1007/s13311-018-0644-1. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 24, 2017)
57
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2015)
34
Estimated Study Completion Date August 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • have spinal cord injury of at least 6 months duration.
  • be between the ages of 16 - 72 years old.
  • be able to sit at the edge of the mat without the assistance of another person.
  • be able to tolerate standing.
  • have at least mild spasticity affecting the lower extremity muscles.
  • be able to understand and provide own consent
  • You may participate if you use prescription medications, including baclofen pump for control of spasticity, as the dosage is stable.
  • obtain medical clearance for standing if you have been injured more than 1 year and are not regularly walking or standing.

Exclusion Criteria:

  • progressive or potentially progressive spinal lesions, including degenerative, or progressive vascular disorders of the spine and/or spinal cord.
  • neurologic level below spinal level T12
  • history of cardiovascular irregularities
  • problems following instructions
  • orthopedic problems that would limit your participation in the protocol (e.g. knee or hip flexion contractures of greater than 10 degrees).
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years to 72 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE
Contact: Edelle Field-Fote, PT, PhD 404-603-4274 Edelle_Field-Fote@Shepherd.org
Contact: Elizabeth Sasso, PT, DPT 404-350-7551 Elizabeth_sasso@shepherd.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02340910
Other Study ID Numbers  ICMJE WBV-612299
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Shepherd Center, Atlanta GA
Study Sponsor  ICMJE Shepherd Center, Atlanta GA
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE Not Provided
PRS Account Shepherd Center, Atlanta GA
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP