Assessment of Vasomotion of People With Spinal Cord Injury

Learn more about:
Related Clinical Trial
Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury Retraining Walking After Spinal Cord Injury Spinal Cord Injury Exercise and Nutrition Conceptual Engagement Body Composition Assessment in Spinal Cord Injury Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality Treatment Study Medico-economical Impact of the Brindley Neurosurgical Technique in France Evaluation of Safety and Performance of the Atalante System With Patients With Lower Limb Paralysis The Safety of ahSC in Chronic SCI With Rehabilitation Evaluation of an Advanced Lower Extremity Neuroprostheses Natural History of Shoulder Pathology in Manual Wheelchair Users Correlation Between Pressure Differences and Micro-vascularization Changes in Bedridden Paraplegic Patient Quantification of the Pressure Threshold Related to Tissue Injury in Bedriden Paraplegics Functional Electrical Stimulation With Rowing as Exercise After Spinal Cord Injury Spinal Cord Injury Leg Rehabilitation Multimodal Exercises to Improve Leg Function After Spinal Cord Injury A Neuroprosthesis for Prolonged Standing After SCI Using Multi-Contact Peripheral Nerve Electrodes A Neuroprosthesis for Seated Posture and Balance Robotically Assisted Treadmill Training in Spinal Cord Injury (SCI) Functional Electrical Stimulation Cycling in SCI Exoskeletal-assisted Walking to Improve Mobility, Bowel Function and Cardio-Metabolic Profiles in Persons With SCI Study of the Impact of the Use of a Corset on the Respiratory Function of Patients With Spinal Cord Injury Exercise to Reduce Obesity in Spinal Cord Injury Interactive Telehealth for Wheelchair Users The Feasibility and Effects of Low-load Blood-flow Restricted Exercise Following Spinal Cord Injury Evaluation of a Power Assistance Device for Wheelchair-DUO Assessment of Vasomotion of People With Spinal Cord Injury Adjusting Wheelchair Set-Up to Minimize Shoulder Joint Forces During Propulsion ExoAtlet II For SCI Patients Safety and Performance Evaluation of ReWalk Reciprocating Gait Orthosis (RGO) Pressure Ulcer Formation Prevention in Paraplegics Using Computer and Sensory Substitution Via the Tongue. Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis A Study Testing Safety and Tolerance of the ReWalk Exoskeleton Suit High-intensity Interval Training for Cardiometabolic Health in Persons With Spinal Cord Injury High-intensity Interval Training and Mixed Meal Responses in Persons With Spinal Cord Injury The ReWalk Exoskeletal Walking System for Persons With Paraplegia Gait Training for Individuals With Paraplegia Using the H-MEX Exoskeleton Training With Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion for Patients With Chronic Complete Paraplegia Evaluation of a Hybrid Prototype Strategy (Electrostimulation of Lower Limb Muscles Associated With Voluntary Strengthening of the Upper Limbs) in Reconditioning to Effort in Patients With Chronic Paraplegia.

Brief Title

Assessment of Vasomotion of People With Spinal Cord Injury

Official Title

Assessment of Vasomotion of People With Spinal Cord Injury

Brief Summary

      Spinal cord injury (SCI), causes loss of supra-spinal control of the sympathetic nervous
      system and in some cases loss of sensation. As a result, people with SCI have impaired
      thermoregulatory system and the consequence of this thermoregulatory dysfunction, is that
      they cannot respond to the environmental changes. All the above lead to dysregulation in
      vasomotor tone, skeletal muscle shivering and sweating dysfunction. It is well known that
      skin plays an important role in regulating body temperature and regulates interactions
      between the environment and human body. A previous study in people with incomplete SCI showed
      that there are no differences in core temperature between patients with different level of
      mobility and sensation and different level of lesion, but there are significant differences
      in skin temperature. As mentioned above people with SCI have an impaired thermoregulatory
      capacity due to sudomotor and vasomotor dysfunction and that leads to greater thermal strain
      during rest and exercise when they expose to hot conditions. A previous study that performed
      exercise in people with SCI, highlights the fact that because of the impaired evaporative
      heat loss during exercise in hot conditions, they are in great risk. Because of this risk
      they propose different cooling strategies that promote evaporation such as fans and water
      spraying. It is therefore important to observe the thermoregulatory function (vasomotion and
      sudomotor) in people with SCI when they are exposed to different environments (cold, neutral
      and warm).
    

Detailed Description

      The participants will visit the laboratory three times. At each time the environmental
      chamber will simulate a different environment in a random order for each participant. The
      three different environments will be as follow:

        1. Cold environment 15-17°C and 40-50% relative humidity

        2. Thermoneutral environment 22-24°C and 40-50% relative humidity

        3. Warm environment 33-35°C and 40-50% relative humidity The participants will stay in a
           sited position for 20 minutes in order to collect baseline data and to allow to their
           blood flow and body temperature adapt to the exposing environmental condition each time.
           Immediately after the baseline period the participants will immerse their left hand and
           foot in warm water (34-36°C) for 5 minutes for a consistent starting (hand and foot)
           temperature. Following that participants will immerse their hand and foot in cold water
           (8°C) for 40 minutes. This procedure will be repeated in every measurement and it will
           only change the environment.

      Anthropometric data [self-reported age, self-reported body stature and body mass (DXA, Lunar,
      GE Healthcare Boston, Massachusetts, U.S)] will be collecting at the beginning of the first
      measurement. Medical history of all the participants will be recording. During the study,
      continuous heart rate (Polar Team2. Polar Electro Oy, Kempele, Finland), core temperature
      (telemetric capsules BodyCap, Caen, France), mean skin temperature (wireless thermistors
      iButtons type DS1921H, Maxim/Dallas Semiconductor Corp., USA), finger temperature
      ((Smartreader 8 Plus, ACR, Vancouver, Canada), skin blood flow and sweat rate data (laser
      Doppler flow-meter PeriFlux System 5010, function unit; Perimed, Stockholm, Sweden and
      PeriFlux System 4002, master unit, satellite unit; Perimed, Stockholm, Sweden) will be
      collecting. Blood pressure will also be monitoring every 10 minutes with an automatic
      sphygmomanometer (Omron Healthcare M6 comfort, Japan). Skin temperature data will be
      collecting from four sites (chest, arm, thigh, and leg) and will be expressed as mean skin
      temperature according to the formula of Ramanathan (Tsk = [0.3(chest + arm) + 0.2(thigh +
      leg)]. Questionnaires (thermal sensation scale: -3 = cold; +3 = hot) will be used to assess
      participants' thermal comfort/sensation and pain.
    


Study Type

Interventional


Primary Outcome

Heart rate


Condition

Spinal Cord Injuries

Intervention

Cold environment participants with spinal cord injury

Study Arms / Comparison Groups

 Cold environment participants with spinal cord injury
Description:  In a cold environment (15-17°C and 40-50% relative humidity), participants will stay in a sited position for 20 minutes in order to collect baseline data and to allow their blood flow and body temperature adapt to the exposing environmental condition. Immediately after the baseline period participants will immerse their left hand and foot in warm water (34-36°C) for five minutes for a consistent starting (hand and foot) temperature. Following that participants will immerse their hand and foot in cold water (8°C) for 40 minutes.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

16

Start Date

February 1, 2019

Completion Date

July 25, 2020

Primary Completion Date

July 25, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  People with spinal cord injury below thoracic spine 6, at least six months after the
             injury.

          -  Healthy adult participants, non-smokers, no disease and/or taking medicines

        Exclusion Criteria:

          -  People under the age of 18;

          -  People taking any medicines that affect vasomotion (e.g. for hypertension, thrombosis,
             etc.)

          -  People with other chronic diseases (e.g. diabetes)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Andreas Flouris, PhD, , 

Location Countries

Greece

Location Countries

Greece

Administrative Informations


NCT ID

NCT04215939

Organization ID

9. Vasomotion & spinal


Responsible Party

Sponsor-Investigator

Study Sponsor

Petros Dinas

Collaborators

 European Commission

Study Sponsor

Andreas Flouris, PhD, Study Chair, FAME Laboratory, Department of Exercise Science, University of Thessaly, Greece


Verification Date

November 2020