Spinal Cord InjuryNCT02043106
Can Vibration Stimulation of the Foot Sole Activate Leg Muscles?
A study testing plantar vibration in people with Spinal Cord Injury, run by Wilfrid Laurier University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- plantar vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- no spinal cord injury
Who cannot join
- any musculoskeletal or neurological disease that affects movement or balance
Trial locations and contacts
1 site in 1 country.
Canada1 site
Biomechanics Lab, Wilfrid Laurier University
Waterloo, Ontario, N2L 3C5
About this study
Official title: 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.
- Conditions
- Spinal Cord Injury
- Being tested
- plantar vibration
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plantar vibrationOther
| Study group | Role | What they receive |
|---|---|---|
| spinal cord injury | Experimental | Individuals who have sustained an incomplete spinal cord injury Receives: Other: plantar vibration |
| non-spinal cord injury | Active comparator | Individuals who have not sustained a spinal cord injury Receives: Other: plantar vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 months after experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wilfrid Laurier University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Stephen Perry, Wilfrid Laurier University
- Investigators
- Stephen D Perry, PhD, Study director, Wilfrid Laurier University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043106
- Sponsor's protocol ID
- MC_SCIPS
- Status last verified
- Mar 2015
- First submitted
- 25 Nov 2013
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plantar Cutaneous Stimulation Used to Elicit Muscle Activity in Individuals With Incomplete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02043106
- Acronym / sponsor ID
- MC_SCIPS
- Conditions
- Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Wilfrid Laurier UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spinal cord injury | Experimental | Other: plantar vibrationIndividuals who have sustained an incomplete spinal cord injury |
| non-spinal cord injury | Active comparator | Other: plantar vibrationIndividuals who have not sustained a spinal cord injury |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- no spinal cord injury
Key exclusion criteria (1 listed)
- any musculoskeletal or neurological disease that affects movement or balance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plantar vibration | Other | non-spinal cord injury, spinal cord injury |
Primary outcome
Muscle activity
Time frame: up to 2 months after experiment
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen D Perry, PhD study director
Wilfrid Laurier University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plantar vibration in people with Spinal Cord Injury, run by Wilfrid Laurier University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle activity (time frame: up to 2 months after experiment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.