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Foot Skin Temperature and Balance Control

Primary Purpose

Mechanoreceptor, Perpherial Hypothermia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
active movement
Sponsored by
Dr. Stephen Perry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Mechanoreceptor focused on measuring sensory receptors, balance control, gait, temperature

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18-25 years of age

Exclusion Criteria:

  • CONDITIONS AFFECTING BALANCE,
  • CONDITIONS AFFECTING CIRCULATION (EX: FROSTBITE), AND
  • ANY OTHER CONDITIONS AFFECT SENSORY PERCEPTION.

Sites / Locations

  • WLU Biomechanics Laboratory

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

active movement

Arm Description

use a light treadmill run to raise feet temperature

Outcomes

Primary Outcome Measures

Balance stability margin (how close their body gets to perimeter of their base of support)
change in ability to control body movements during standing and walking

Secondary Outcome Measures

Sensory threshold (change in perception of touch pressure on the sole of the foot, taken after every change in foot temperature)
change in perception of touch pressure on the sole of the foot, taken after every change in foot temperature
Foot skin temperature
change in infrared measurement of skin temperature

Full Information

First Posted
February 28, 2015
Last Updated
June 8, 2015
Sponsor
Dr. Stephen Perry
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1. Study Identification

Unique Protocol Identification Number
NCT02388789
Brief Title
Foot Skin Temperature and Balance Control
Official Title
Effects of Changes in Foot Skin Temperature on Plantar-surface Mechanoreceptor Sensitivity and Balance Control
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Stephen Perry

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate whether mechanoreceptor sensitivity of the sole of the feet increases with increased foot temperature and how a heightened sensation may improve characteristics of balance control and gait. As an extension, the investigators also want to determine whether lower limb movement is an efficient activity of increasing foot temperature. There are several objectives of this study. The investigators want to determine the effect of active recovery (via lower limb movements) on increasing plantar temperature, determine the effect of increased plantar temperature on plantar sensation and determine the effect of increased plantar sensation on balance control and gait characteristics. Participants will be asked to complete various tasks under different conditions. Conditions include decreased feet temperature via ice bath emersion, baseline feet temperature (participant's normal temperature after a ten minute equilibration period), and increased feet temperature via active movement of the lower limb. Tasks include walking across the room, performing active movement of the lower limb and a 10 minute treadmill walk. Gait movement will be collected with a three-dimensional motion capture system (Optotrak) and force plates. Feet temperature and sensation information will be collected with a temperature probe (infrared) and monofilaments.
Detailed Description
Between 10-15 healthy young adults of both males and females will be recruited. A screening questionnaire will be administered to ensure that participants are appropriate for the study. Upon arrival, participants will be required to sit with their feet slightly elevated from the ground, resting on a stool for 10 minutes to allow for adjustment to room temperature (equilibration). During this time, participants will complete a questionnaire regarding their experiences with the temperature of their feet including questions similar to, "On average would you say that you have cold feet, average feet or warm feet? Describe your feet's ability to adapt to temperature changes. Do you experience a tingling feeling on the bottom of your feet?" Following the equilibration period, the researcher will place 12 infrared markers on the participant. The participant will then receive a brief outline of the procedure and appropriate instructions before beginning the experiment. All trials will be performed barefoot. There will be a total of 3 types of testing. The first is a monofilament test. The researcher will apply varying monofilaments sizes to the participants' soles of their feet. These test are included to measure touch sensation of the sole of the foot. The second is a One Leg Stance Test where the participant will stand on a force plate, balanced on one leg for 30 seconds per trial while Optotrak information is collected. The participant will complete a total of 3 trials. The third is the Gait Termination Test where the participant will be instructed to walk along 6 metres over 2 force plates. A total of 10 trials will be completed with 3 randomized trials where the participant will be instructed to terminate their gait unexpectedly (by a buzzer) before reaching the force plates. Optotrak information will be collected simultaneously. The researcher will record plantar temperature intermittently in between the above tests and different conditions. The infrared temperature probe does not make any contact with the skin. The specific outline of the procedure including the order of the conditions and tasks are explained here. The first condition is the Baseline Condition where all 3 types of tests will be administered. Then the participant's feet will be immersed in an ice bath at 2-3 degrees Celsius for 10-15 minutes (with their feet temperature recorded every 2 minutes) in preparation for the Decreased Feet Temperature Condition. Here, all 3 types of tests will be administered. Then each participant will actively recover by walking on a treadmill at a speed of 3.5 miles/hour and grade of 0% for 10 minutes, to prepare the for Increased Feet Temperature Condition. Intermittent foot temperature measurements will be taken every 2 minutes during the treadmill walk. After the 10 minute walk, all 3 types of tests will be administered. This will be the end of the experiment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanoreceptor, Perpherial Hypothermia
Keywords
sensory receptors, balance control, gait, temperature

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active movement
Arm Type
Experimental
Arm Description
use a light treadmill run to raise feet temperature
Intervention Type
Other
Intervention Name(s)
active movement
Intervention Description
same as arm description
Primary Outcome Measure Information:
Title
Balance stability margin (how close their body gets to perimeter of their base of support)
Description
change in ability to control body movements during standing and walking
Time Frame
within subject (every 40 minutes over 2 hours), same day
Secondary Outcome Measure Information:
Title
Sensory threshold (change in perception of touch pressure on the sole of the foot, taken after every change in foot temperature)
Description
change in perception of touch pressure on the sole of the foot, taken after every change in foot temperature
Time Frame
within subject (every 40 minutes over 2 hours), same day
Title
Foot skin temperature
Description
change in infrared measurement of skin temperature
Time Frame
within subject (every 40 minutes over 2 hours), same day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-25 years of age Exclusion Criteria: CONDITIONS AFFECTING BALANCE, CONDITIONS AFFECTING CIRCULATION (EX: FROSTBITE), AND ANY OTHER CONDITIONS AFFECT SENSORY PERCEPTION.
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
WLU Biomechanics Laboratory
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3C5
Country
Canada

12. IPD Sharing Statement

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Foot Skin Temperature and Balance Control

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