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

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Short Duration
Long Duration
Sponsored by
Shepherd Center, Atlanta GA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring spasticity, whole body vibration, walking

Eligibility Criteria

16 Years - 72 Years (Child, Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Shepherd Center, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Short duration

Long duration

Arm Description

Short Duration WBV consists of 8 45-sec bouts of 50Hz WBV followed by a 1-minute seated rest

Long Duration WBV consists of 16 bouts 45-sec of 50Hz WBV followed by a 1-minute seated rest

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 9, 2015
Last Updated
March 8, 2021
Sponsor
Shepherd Center, Atlanta GA
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02340910
Brief Title
Dose-Response Effects of Whole Body Vibration on Spasticity and Walking in SCI
Acronym
WBV
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 2, 2015 (Actual)
Primary Completion Date
March 6, 2020 (Actual)
Study Completion Date
March 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shepherd Center, Atlanta GA
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. 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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
spasticity, whole body vibration, walking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Masked allocation and intervention
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Short duration
Arm Type
Experimental
Arm Description
Short Duration WBV consists of 8 45-sec bouts of 50Hz WBV followed by a 1-minute seated rest
Arm Title
Long duration
Arm Type
Experimental
Arm Description
Long Duration WBV consists of 16 bouts 45-sec of 50Hz WBV followed by a 1-minute seated rest
Intervention Type
Procedure
Intervention Name(s)
Short Duration
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Long Duration
Intervention Description
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 Outcome Measure Information:
Title
Spasticity Assessments
Description
Pendulum test, Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) Questionnaire, Electrophysiological testing (Soleus H-reflex)
Time Frame
Estimated 1 hour
Secondary Outcome Measure Information:
Title
Walking ability
Description
Walking speed, endurance and pattern will be assessed while wearing motion capture sensors
Time Frame
Estimated 30 minutes
Title
Strength
Description
5 times sit to stand assessment, testing of upper leg muscle strength using force measurements
Time Frame
Estimated 20 minutes
Title
Pain perception
Description
SCI Pain Basic Dataset Questionnaire
Time Frame
Estimated 20 minutes
Title
Upper Extremity Tests
Description
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
Title
Ankle Clonus Test/Foot
Description
Ankle spasticity will be measured using motion capture sensors to record ankle joint angles.
Time Frame
Estimated 15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Shepherd Center, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29959653
Citation
Estes S, Iddings JA, Ray S, Kirk-Sanchez NJ, Field-Fote EC. Comparison of Single-Session Dose Response Effects of Whole Body Vibration on Spasticity and Walking Speed in Persons with Spinal Cord Injury. Neurotherapeutics. 2018 Jul;15(3):684-696. doi: 10.1007/s13311-018-0644-1.
Results Reference
background
Links:
URL
http://shepherd.org
Description
Related Info

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

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