Dose-Response Effects of Whole Body Vibration on Spasticity and Walking in SCI
WBV
1 other identifier
interventional
46
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2015
CompletedFirst Posted
Study publicly available on registry
January 19, 2015
CompletedStudy Start
First participant enrolled
February 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2020
CompletedMarch 9, 2021
March 1, 2021
5.1 years
January 9, 2015
March 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Spasticity Assessments
Pendulum test, Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) Questionnaire, Electrophysiological testing (Soleus H-reflex)
Estimated 1 hour
Secondary Outcomes (5)
Walking ability
Estimated 30 minutes
Strength
Estimated 20 minutes
Pain perception
Estimated 20 minutes
Upper Extremity Tests
Estimated 5 minutes
Ankle Clonus Test/Foot
Estimated 15 minutes
Study Arms (2)
Short duration
EXPERIMENTALShort Duration WBV consists of 8 45-sec bouts of 50Hz WBV followed by a 1-minute seated rest
Long duration
EXPERIMENTALLong Duration WBV consists of 16 bouts 45-sec of 50Hz WBV followed by a 1-minute seated rest
Interventions
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.
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 .
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shepherd Center, Atlanta GAlead
- National Institutes of Health (NIH)collaborator
Study Sites (1)
Shepherd Center, Inc.
Atlanta, Georgia, 30309, United States
Related Publications (1)
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.
PMID: 29959653BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Masked allocation and intervention
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2015
First Posted
January 19, 2015
Study Start
February 2, 2015
Primary Completion
March 6, 2020
Study Completion
March 6, 2020
Last Updated
March 9, 2021
Record last verified: 2021-03