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

• ClinicalTrials.gov Identifier: NCT02340910
• Recruitment Status: Completed
• First Posted: January 19, 2015
• Last Update Posted: March 9, 2021
• Sponsor: Shepherd Center, Atlanta GA
• Collaborator: National Institutes of Health (NIH)
• Information provided by (Responsible Party): Shepherd Center, Atlanta GA

Tracking Information

• First Submitted Date: January 9, 2015
• First Posted Date: January 19, 2015
• Last Update Posted Date: March 9, 2021
• Actual Study Start Date: February 2, 2015
• Actual Primary Completion Date: March 6, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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 (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 Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dose-Response Effects of Whole Body Vibration on Spasticity and Walking in SCI
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:

Masked allocation and intervention

Primary Purpose: Treatment

• Condition: Spinal Cord Injury

Intervention

• 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 a total of 20 sessions over 4 consecutive 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.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: April 17, 2019): 46
• Original Estimated Enrollment (submitted: January 13, 2015): 34
• Actual Study Completion Date: March 6, 2020
• Actual Primary Completion Date: March 6, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02340910
• Other Study ID Numbers: WBV-612299
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Shepherd Center, Atlanta GA
• Original Responsible Party: Same as current
• Current Study Sponsor: Shepherd Center, Atlanta GA
• Original Study Sponsor: Same as current
• Collaborators: National Institutes of Health (NIH)
• Investigators: Not Provided
• PRS Account: Shepherd Center, Atlanta GA
• Verification Date: March 2021