The Effect of Whole Body Vibration on Spasticity in Spinal Cord Injury Patients

Status: Unknown status
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Extended periods of tilt table standing have been observed to improve spasticity in individuals with spinal cord injury (SCI). The purpose of this study is to determine the effect of three sessions of whole body vibration while tilt table standing on spasticity in individuals with a complete or incomplete SCI above the neurological level of T10. Participants in this study will undergo whole body vibration while standing on a tilt table for a total of approximately 14 minutes for a total of 3 sessions on 3 separate days. Spasticity monitoring will be evaluated prior to and after the intervention with the Modified Penn Spasm Frequency Scale, an interview to obtain the individual's perception and impression of the effect of whole body vibration on the performance of activities of daily living, quality of life, pain scale, and global impression of change.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: No
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• The subject is male or female, 18 to 70 years of age, inclusive.

• The subject has neurological impairment secondary to a spinal cord injury that occurred at least six (6) months prior to the study that can be categorized as either a complete or incomplete spinal cord injury.

• The neurological level of lesion is above T10.

• The subject has self-reported stable moderate to severe spasticity (Modified Ashworth Score scale at or greater than a 2 at the hips or knees). Patients can be enrolled if on a stable dose of oral medications or intrathecal medications.

• The subject has self reported spasticity that negatively impacts his or her quality of life, impairs ability to perform activities of daily living (such as transfers, sitting, sleep, wheelchair use, and hobbies).

• The subject is able to stand with the assistance of a tilt table at a minimum of 70 degrees for 45 minutes without significant orthostasis or other adverse events or symptoms.

• The subject is able and willing to comply with the protocol.

• The subject is able to and has voluntarily given informed consent prior to the performance of any study-specific procedures.

Locations
United States
New Jersey
Kessler Institute for Rehabilitation
Recruiting
West Orange
Contact Information
Primary
Trevor A. Dyson-Hudson, M.D.
tdysonhudson@kesslerfoundation.org
973-324-3576
Backup
Steven C. Kirshblum, M.D.
skirshblum@kessler-rehab.com
800-248-3221
Time Frame
Start Date: April 2014
Completion Date: July 2015
Participants
Target number of participants: 40
Treatments
Experimental: Vibration with tilt-table standing
Participants in this arm will undergo alternating side-to-side, whole body vibration while standing on a tilt table for multiple treatments for a total of approximately 14 minutes for 3 sessions over 3 different days
Authors
Steven C. Kirshblum, Trevor A. Dyson-Hudson, Alice Hon
Related Therapeutic Areas
Sponsors
Leads: Kessler Foundation

This content was sourced from clinicaltrials.gov

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