MechanoreceptorNCT02388789
Foot Skin Temperature and Balance Control
A study testing active movement in people with Mechanoreceptor and Perpherial Hypothermia, run by Dr. Stephen Perry at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Mechanoreceptor, Perpherial Hypothermia
- What is being tested?
- active movement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2015to Apr 2015
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-25 years of age
Who cannot join
- CONDITIONS AFFECTING BALANCE,
- CONDITIONS AFFECTING CIRCULATION (EX: FROSTBITE), AND
- ANY OTHER CONDITIONS AFFECT SENSORY PERCEPTION.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Changes in Foot Skin Temperature on Plantar-surface Mechanoreceptor Sensitivity and Balance Control
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.
Read the 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.
- Conditions
- Mechanoreceptor, Perpherial Hypothermia
- Being tested
- active movement
- Keywords
- sensory receptors, balance control, gait, temperature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active movementOther
same as arm description
| Study group | Role | What they receive |
|---|---|---|
| active movement | Experimental | use a light treadmill run to raise feet temperature Receives: Other: active movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within subject (every 40 minutes over 2 hours), same day
Secondary outcomes (2)
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
Measured: within subject (every 40 minutes over 2 hours), same day
Foot skin temperature
change in infrared measurement of skin temperature
Measured: within subject (every 40 minutes over 2 hours), same day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MechanoreceptorStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Stephen Perry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Stephen Perry, Wilfrid Laurier University
- Investigators
- Stephen D Perry, PhD, Study director, Wilfrid Laurier University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388789
- Sponsor's protocol ID
- KB_CMTS
- Status last verified
- Jun 2015
- First submitted
- 28 Feb 2015
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Changes in Foot Skin Temperature on Plantar-surface Mechanoreceptor Sensitivity and Balance Control
- ClinicalTrials.gov ID
- NCT02388789
- Acronym / sponsor ID
- KB_CMTS
- Conditions
- Mechanoreceptor, Perpherial Hypothermia
- Keywords
- sensory receptors, balance control, gait, temperature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Dr. Stephen PerryUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 17 Mar 2015 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| active movement | Experimental | Other: active movementuse a light treadmill run to raise feet temperature |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-25 years of age
Key exclusion criteria (3 listed)
- CONDITIONS AFFECTING BALANCE,
- CONDITIONS AFFECTING CIRCULATION (EX: FROSTBITE), AND
- ANY OTHER CONDITIONS AFFECT SENSORY PERCEPTION.
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 |
|---|---|---|
| active movementsame as arm description | Other | active movement |
Primary outcome
Balance stability margin (how close their body gets to perimeter of their base of support)
Time frame: within subject (every 40 minutes over 2 hours), same day
change in ability to control body movements during standing and walking
2 secondary outcomes
Sensory threshold (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
Foot skin temperature
Time frame: within subject (every 40 minutes over 2 hours), same day
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 9 Jun 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 active movement in people with Mechanoreceptor and Perpherial Hypothermia, run by Dr. Stephen Perry 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 3 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 9 Jun 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?
Balance stability margin (how close their body gets to perimeter of their base of support) (time frame: within subject (every 40 minutes over 2 hours), same day). 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 9 Jun 2015.