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

Shepherd Center, Atlanta GA46 enrolled

Overview

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)

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Spinal Cord Injury

Interventions

Short DurationPROCEDURE

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 DurationPROCEDURE

Eligibility

Sex: ALLMin age: 16 YearsMax age: 72 Years

Medical Language ↔ Plain English

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)

Locations (1)

Shepherd Center, Inc.

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Spasticity Assessments

Pendulum test, Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) Questionnaire, Electrophysiological testing (Soleus H-reflex)

Time frame: Estimated 1 hour

Secondary Outcomes

Walking ability

Walking speed, endurance and pattern will be assessed while wearing motion capture sensors

Time frame: Estimated 30 minutes

Strength

5 times sit to stand assessment, testing of upper leg muscle strength using force measurements

Time frame: Estimated 20 minutes

Pain perception

SCI Pain Basic Dataset Questionnaire

Time frame: Estimated 20 minutes

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.

Time frame: Estimated 5 minutes

Ankle Clonus Test/Foot

Ankle spasticity will be measured using motion capture sensors to record ankle joint angles.

Time frame: Estimated 15 minutes

Data from ClinicalTrials.gov

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