ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02340910
Recruitment Status : Recruiting
First Posted : January 19, 2015
Last Update Posted : August 17, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Shepherd Center, Atlanta GA

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 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 : January 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


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 5 days a week for 4 weeks .





Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 72 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

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


Contacts
Contact: Edelle Field-Fote, PT, PhD 404-603-4274 Edelle_Field-Fote@Shepherd.org
Contact: Elizabeth Sasso, PT, DPT 404-350-7551 Elizabeth_sasso@shepherd.org

Locations
United States, Georgia
Shepherd Center, Inc. Recruiting
Atlanta, Georgia, United States, 30309
Contact: Edelle Field-Fote, PT, PhD, FAPTA    (404) 603-4274    Edelle_Field-Fote@Shepherd.org   
Contact: Elizabeth Sasso, PT, DPT    404-350-7551    Elizabeth_sasso@shepherd.org   
Sponsors and Collaborators
Shepherd Center, Atlanta GA
National Institutes of Health (NIH)

Additional Information:
Publications:
Responsible Party: Shepherd Center, Atlanta GA
ClinicalTrials.gov Identifier: NCT02340910     History of Changes
Other Study ID Numbers: WBV-612299
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018

Keywords provided by Shepherd Center, Atlanta GA:
spasticity
whole body vibration
walking

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries