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

Not Applicable

Completed

• Conditions: Spinal Cord Injury
• Interventions: Procedure: Long Duration; Procedure: Short Duration

• Registration Number: NCT02340910
• Lead Sponsor: Shepherd Center, Atlanta GA

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 Timeline

• Study First Submitted: 2015-01-09
• Study First Submitted QC: 2015-01-13
• Study First Posted: 2015-01-19
• Study Start: 2015-02-02
• Primary Completion: 2020-03-06
• Study Completion: 2020-03-06
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long duration	Long Duration	Long Duration WBV consists of 16 bouts 45-sec of 50Hz WBV followed by a 1-minute seated rest
Short duration	Short Duration	Short Duration WBV consists of 8 45-sec bouts of 50Hz WBV followed by a 1-minute seated rest

Primary Outcome Measures

Name	Time	Method
Spasticity Assessments	Estimated 1 hour	Pendulum test, Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) Questionnaire, Electrophysiological testing (Soleus H-reflex)

Secondary Outcome Measures

Name	Time	Method
Ankle Clonus Test/Foot	Estimated 15 minutes	Ankle spasticity will be measured using motion capture sensors to record ankle joint angles.
Strength	Estimated 20 minutes	5 times sit to stand assessment, testing of upper leg muscle strength using force measurements
Upper Extremity Tests	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.
Walking ability	Estimated 30 minutes	Walking speed, endurance and pattern will be assessed while wearing motion capture sensors
Pain perception	Estimated 20 minutes	SCI Pain Basic Dataset Questionnaire

Trial Locations

Locations (1)

Shepherd Center, Inc.; 🇺🇸 Atlanta, Georgia, United States