Skip to main content
OpenTrials
Completed

NCT Number: NCT02340910

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

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

16 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shepherd Center, Inc.

Atlanta, Georgia, 30309, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Short Duration

Procedure

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

Procedure

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 .

Primary outcomes

  1. Spasticity Assessments

    Time frame: Estimated 1 hour

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

Secondary outcomes

  1. Walking ability

    Time frame: Estimated 30 minutes

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

  2. Strength

    Time frame: Estimated 20 minutes

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

  3. Pain perception

    Time frame: Estimated 20 minutes

    SCI Pain Basic Dataset Questionnaire

  4. 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.

  5. Ankle Clonus Test/Foot

    Time frame: Estimated 15 minutes

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

Sponsors and collaborators

Lead sponsor

Shepherd Center, Atlanta GA

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Acronym: WBV

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jan 19, 2015
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.