Can Vibration Stimulation of the Foot Sole Activate Leg Muscles?
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
plantar vibration
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury
Eligibility Criteria
Inclusion Criteria:
- no spinal cord injury
Exclusion Criteria:
- any musculoskeletal or neurological disease that affects movement or balance
Sites / Locations
- Biomechanics Lab, Wilfrid Laurier University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
spinal cord injury
non-spinal cord injury
Arm Description
Individuals who have sustained an incomplete spinal cord injury
Individuals who have not sustained a spinal cord injury
Outcomes
Primary Outcome Measures
Muscle activity
Muscle activity will be measured by electromyography equipment (two electrodes placed on the muscle belly) and then the outcome measures will be the description of both the timing (relative to task onset) and magintude of muscle activity.
Secondary Outcome Measures
Full Information
NCT ID
NCT02043106
First Posted
November 25, 2013
Last Updated
March 5, 2015
Sponsor
Wilfrid Laurier University
1. Study Identification
Unique Protocol Identification Number
NCT02043106
Brief Title
Can Vibration Stimulation of the Foot Sole Activate Leg Muscles?
Official Title
Plantar Cutaneous Stimulation Used to Elicit Muscle Activity in Individuals With Incomplete Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wilfrid Laurier University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Participants will be asked to complete three different tests (standing, stepping and assisted walking) and will experience three different experimental conditions during each test. The three conditions are types of vibratory plantar cutaneous stimulation, which include no vibratory stimulation, submaximal vibratory stimulation and supramaximal vibratory stimulation. In the first condition, participants will experience no stimulation applied to any part of the body. In the second condition, a submaximal vibratory stimulus will be delivered at 90% of the participant's threshold to the surface of the foot. In the third condition, a supramaximal vibratory stimulus will be delivered at three times the participant's threshold. The hypothesis is that this plantar stimulation (90% threshold and supramaximal) will elicit increased muscle activity during these tests. If the hypothesis is positive then this protocol will also be presented in incomplete spinal cord injuried participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
spinal cord injury
Arm Type
Experimental
Arm Description
Individuals who have sustained an incomplete spinal cord injury
Arm Title
non-spinal cord injury
Arm Type
Active Comparator
Arm Description
Individuals who have not sustained a spinal cord injury
Intervention Type
Other
Intervention Name(s)
plantar vibration
Primary Outcome Measure Information:
Title
Muscle activity
Description
Muscle activity will be measured by electromyography equipment (two electrodes placed on the muscle belly) and then the outcome measures will be the description of both the timing (relative to task onset) and magintude of muscle activity.
Time Frame
up to 2 months after experiment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
no spinal cord injury
Exclusion Criteria:
any musculoskeletal or neurological disease that affects movement or balance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen D Perry, PhD
Organizational Affiliation
Wilfrid Laurier University
Official's Role
Study Director
Facility Information:
Facility Name
Biomechanics Lab, Wilfrid Laurier University
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3C5
Country
Canada
12. IPD Sharing Statement
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Can Vibration Stimulation of the Foot Sole Activate Leg Muscles?
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