NCT02043106

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

3 months

First QC Date

November 25, 2013

Last Update Submit

March 5, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 2 months after experiment

Study Arms (2)

spinal cord injury

EXPERIMENTAL

Individuals who have sustained an incomplete spinal cord injury

Other: plantar vibration

non-spinal cord injury

ACTIVE COMPARATOR

Individuals who have not sustained a spinal cord injury

Other: plantar vibration

Interventions

non-spinal cord injuryspinal cord injury

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • no spinal cord injury

You may not qualify if:

  • any musculoskeletal or neurological disease that affects movement or balance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biomechanics Lab, Wilfrid Laurier University

Waterloo, Ontario, N2L 3C5, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Stephen D Perry, PhD

    Wilfrid Laurier University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoicate Professor

Study Record Dates

First Submitted

November 25, 2013

First Posted

January 23, 2014

Study Start

January 1, 2014

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations