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

Sponsor

Shepherd Center, Atlanta GA (Other)

Overall Status

Completed

CT.gov ID

NCT02340910

Collaborator

National Institutes of Health (NIH) (NIH)

Enrollment

Location

Arms

61.1

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury	Procedure: Short Duration Procedure: Long Duration	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

Masked allocation and intervention

Primary Purpose:

Treatment

Actual Study Start Date :

Feb 2, 2015

Actual Primary Completion Date :

Mar 6, 2020

Actual Study Completion Date :

Mar 6, 2020

Arms and Interventions

Arm	Intervention/Treatment
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 .

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 72 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)