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

Spinal Cord Injury Clinical Trial

— WBV  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02340910
• Other study ID #: WBV-612299
• Status: Completed
• Phase: N/A
• Start date: February 2, 2015
• Est. completion date: March 6, 2020

Study information

• Verified date: March 2021
• Source: Shepherd Center, Atlanta GA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 6, 2020
• Est. primary completion date: March 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 72 Years

Eligibility

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)

Related Conditions & MeSH terms

• Spinal Cord Injuries
• 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.
• 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 .

Locations

Country	Name	City	State
United States	Shepherd Center, Inc.	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Shepherd Center, Atlanta GA	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spasticity Assessments	Pendulum test, Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) Questionnaire, Electrophysiological testing (Soleus H-reflex)	Estimated 1 hour
Secondary	Walking ability	Walking speed, endurance and pattern will be assessed while wearing motion capture sensors	Estimated 30 minutes
Secondary	Strength	5 times sit to stand assessment, testing of upper leg muscle strength using force measurements	Estimated 20 minutes
Secondary	Pain perception	SCI Pain Basic Dataset Questionnaire	Estimated 20 minutes
Secondary	Upper Extremity Tests	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.	Estimated 5 minutes
Secondary	Ankle Clonus Test/Foot	Ankle spasticity will be measured using motion capture sensors to record ankle joint angles.	Estimated 15 minutes

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