- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02043106
Can Vibration Stimulation of the Foot Sole Activate Leg Muscles?
March 5, 2015 updated by: Dr. Stephen Perry, Wilfrid Laurier University
Plantar Cutaneous Stimulation Used to Elicit Muscle Activity in Individuals With Incomplete Spinal Cord Injury
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Waterloo, Ontario, Canada, N2L 3C5
- Biomechanics Lab, Wilfrid Laurier University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- no spinal cord injury
Exclusion Criteria:
- any musculoskeletal or neurological disease that affects movement or balance
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: spinal cord injury
Individuals who have sustained an incomplete spinal cord injury
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Active Comparator: non-spinal cord injury
Individuals who have not sustained a spinal cord injury
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle activity
Time Frame: up to 2 months after experiment
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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.
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up to 2 months after experiment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Stephen D Perry, PhD, Wilfrid Laurier University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
November 25, 2013
First Submitted That Met QC Criteria
January 20, 2014
First Posted (Estimate)
January 23, 2014
Study Record Updates
Last Update Posted (Estimate)
March 6, 2015
Last Update Submitted That Met QC Criteria
March 5, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MC_SCIPS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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