Dose-Response Effects of Whole Body Vibration on Spasticity and Walking in SCI (WBV)
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|ClinicalTrials.gov Identifier: NCT02340910|
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : March 9, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Procedure: Short Duration Procedure: Long Duration||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Masked allocation and intervention|
|Actual Study Start Date :||February 2, 2015|
|Actual Primary Completion Date :||March 6, 2020|
|Actual Study Completion Date :||March 6, 2020|
Experimental: Short duration
Short Duration WBV consists of 8 45-sec bouts of 50Hz WBV followed by a 1-minute seated rest
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.
Experimental: Long duration
Long Duration WBV consists of 16 bouts 45-sec of 50Hz WBV followed by a 1-minute seated rest
Procedure: 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 .
- Spasticity Assessments [ Time Frame: Estimated 1 hour ]Pendulum test, Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) Questionnaire, Electrophysiological testing (Soleus H-reflex)
- Walking ability [ Time Frame: Estimated 30 minutes ]Walking speed, endurance and pattern will be assessed while wearing motion capture sensors
- Strength [ Time Frame: Estimated 20 minutes ]5 times sit to stand assessment, testing of upper leg muscle strength using force measurements
- Pain perception [ Time Frame: Estimated 20 minutes ]SCI Pain Basic Dataset Questionnaire
- 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.
- Ankle Clonus Test/Foot [ Time Frame: Estimated 15 minutes ]Ankle spasticity will be measured using motion capture sensors to record ankle joint angles.
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|Ages Eligible for Study:||16 Years to 72 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02340910
|United States, Georgia|
|Shepherd Center, Inc.|
|Atlanta, Georgia, United States, 30309|
|Responsible Party:||Shepherd Center, Atlanta GA|
|Other Study ID Numbers:||
|First Posted:||January 19, 2015 Key Record Dates|
|Last Update Posted:||March 9, 2021|
|Last Verified:||March 2021|
whole body vibration
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Peripheral Nervous System Agents
Respiratory System Agents