<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04421794</url>
  </required_header>
  <id_info>
    <org_study_id>2020 - 00533</org_study_id>
    <nct_id>NCT04421794</nct_id>
  </id_info>
  <brief_title>Effects of Foot Medial Arch Electrical Stimulation on Foot Functions and Balance</brief_title>
  <official_title>Effects of One Electrical Strengthening Session on Foot Functions and Dynamic Postural Balance: a Randomised Controlled Trial in Single Blind</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>La Tour Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>La Tour Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate the immediate effects of sole session of foot medial&#xD;
      arch' NMES on foot strength, arch stability, static plantar pressure distribution and dynamic&#xD;
      postural balance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study design is a randomised controlled trial in population with pronated feet. The aim&#xD;
      of this study is to investigate the immediate effects of sole session of foot medial arch'&#xD;
      NMES on foot strength, arch stability, static plantar pressure distribution and dynamic&#xD;
      postural balance. This is the 2nd study to investigate the effect one session as previous&#xD;
      study showed immediate effect on plantar pressure distribution on the midfoot and durable&#xD;
      effect at 2 months follow-up. However, no studies investigated the effects on others&#xD;
      parameters than plantar pressure.The general objective of our study is to question electrical&#xD;
      stimulation as a modality for foot strengthening to enhance dynamic postural balance and foot&#xD;
      functions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">October 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants will be allocated to the intervention or control group using permuted block randomization with blocks of 4 or 6 patients on a 1:1 ratio.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>This randomised controlled trial is in single blind. Participants will be informed about their treatment group after termination of the study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Foot strength</measure>
    <time_frame>Before and immediately after intervention</time_frame>
    <description>The change of foot strength that will be measured on a pressure platform on the dominant foot before and after intervention (NMES or TENS). This primary outcome will be also measured on the non-dominant foot to assess cross effects.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dynamic postural balance</measure>
    <time_frame>Before and immediately after intervention</time_frame>
    <description>The secondary outcomes include the change of dynamic postural balance in the posterior direction on the dominant foot. All measurements will be performed on the non-dominant foot to assess cross effects. To assess dynamic postural balance performance, we will use the Star Excursion Balance Test (SEBT). The star excursion balance test (SEBT) is a measure of dynamic balance with good to excellent test-retest reliability. The test will be conducted in the anterior, posterior-lateral and posterior-medial directions. The SEBT will be performed with the subject standing barefoot so that the distal end of the longest toe of the stance foot will be placed at the center of the grid. They will have to maintain a single-leg stance while reaching with the contralateral leg to touch as far as possible along the direction by a light touch. The reached distances will be normalized to the respective stance-limb length (anterior superior iliac spine to the inferior border of the medial malleolus).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arch stability</measure>
    <time_frame>Before and immediately after intervention</time_frame>
    <description>The secondary outcomes include the change of arch stability on the dominant foot. This measurement will be performed on the non-dominant foot to assess cross effects. The sit-to-stand double-leg navicular drop test will be used to evaluate longitudinal arch stability. Participants will sit on a chair with their hips, knees, and ankles bent to 90° and the feet resting on the floor. The inferior border of the prominent tuberosity of the navicular bone will be palpated and marked with a pen. Next, the distance of the marked navicular point to the ground in a seated position will be measured using a steel ruler (resolution: 0.5 mm). Then, we will ask the subject to stand barefoot on a 4-in (10.16-cm) box, placing all weight on the foot being measured, while the other foot rested lightly on the box. Finally, the difference between the two measures (sitting - standing) will be calculated and defined as navicular drop (ND).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Static plantar pressure distribution</measure>
    <time_frame>Before and immediately after intervention</time_frame>
    <description>The secondary outcomes include the change of arch stability on the dominant foot. In this study the evaluation of the longitudinal arch of the foot will be made with the use of the Zebris FDM-S dynamometric platform. It will describe foot arch assessment based on the AI calculated on the basis of discretized measurements of distribution of forces on the ground, by means of the platform.&#xD;
According to this theory, a static arch pressure index (SAPI) will be measured by utilizing the average/maximal foot pressure distribution during static single leg standing of 30 seconds with their arms along the body while the subject will have one foot on a Zebris platform. Based on distribution of pressure on the entire foot the SAPI will be calculate as the ratio of the midfoot pressure distribution relative to the whole foot pressure distribution excluding the toes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>NMES group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For the NMES group one portable stimulator (Compex 2, Medicompex SA, Ecublens, Switzerland) will deliver NEMS (15 min; 75 EMS contractions completed during the training session; rise time = 0.25 s and descending time = 0.75 s). In order to maximize muscle tension without accompanying detrimental effects on fatigue onset, biphasic symmetric regular-wave pulsed currents (85 Hz) lasting 400 μs will be delivered. Each 4-s steady tetanic stimulation will be followed by pause lasting 8-s, during which subjects will be submaximally stimulated at 4 Hz on the medial arch muscles. According to the recommendations, the two electrodes are placed behind the head of the first metatarsal to stimulate the medial arch intrinsic muscles. The goal is to attain the highest tolerable level of muscle contraction without discomfort during the 15 minutes and to provide a full tetanic contraction of the intrinsic foot muscles during the contraction time.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>For the control group the one portable stimulator (Compex 2, Medicompex SA, Ecublens, Switzerland) will be used to apply a stimulation of 15 minutes considered by TENS at the lowest intensity detectable by the participant in order to not influence the outcomes of interest. Our aim is to strengthen IFM which is not the role of TENS. The two electrodes will be placed on the dominant foot, at the same place than those for the NMES group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NMES</intervention_name>
    <description>Neuromuscular Electrical Stimulation (NMES) is a non pharmacological intervention that sends electrical impulses to nerves leading to muscle contraction. The electrical stimulation can increase strength and is often used to re-educate or re-train muscles.</description>
    <arm_group_label>NMES group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TENS</intervention_name>
    <description>Transcutaneous electrical nerve stimulation (TENS) is a nonpharmacological intervention that activates a complex neuronal network to reduce pain by activating descending inhibitory systems in the central nervous system to reduce hyperalgesia.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Foot Posture Index (FPI) between +6 à +12 (slight pronation / increased pronation)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of ankle or foot sprain or pain within the last 3 months&#xD;
&#xD;
          -  Fracture in the leg or in the foot that occurred during the last year&#xD;
&#xD;
          -  Severe foot deformity&#xD;
&#xD;
          -  Self-reported disability due to neuromuscular impairment in the lower extremity&#xD;
&#xD;
          -  Neurological or vestibular impairment that affected balance (diabetes mellitus,&#xD;
             lumbosacral radiculopathy, a soft tissue disorder such as Marfan or Ehlers-Danlos&#xD;
             syndrome)&#xD;
&#xD;
          -  Any absolute contraindication to NMES (pacemaker, seizure disorders, pregnancy)&#xD;
&#xD;
          -  Experience of NMES at the foot region or foot core strengthening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boris Gojanovic, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>La Tour Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>La Tour Hospital</name>
      <address>
        <city>Meyrin</city>
        <zip>1217</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>February 17, 2021</last_update_submitted>
  <last_update_submitted_qc>February 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>La Tour Hospital</investigator_affiliation>
    <investigator_full_name>Boris Gojanovic</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Foot</keyword>
  <keyword>Foot strength</keyword>
  <keyword>Stability</keyword>
  <keyword>Plantar pressure</keyword>
  <keyword>Dynamic postural balance</keyword>
  <keyword>Neuromuscular Electrical Stimulation</keyword>
  <keyword>NMES</keyword>
  <keyword>Transcutaneous Electrical Nerve Stimulation</keyword>
  <keyword>TENS</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04421794
org study id: 2020 - 00533
nct id: NCT04421794
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim of this study is to investigate the immediate effects of sole session of foot medial
      arch' NMES on foot strength, arch stability, static plantar pressure distribution and dynamic
      postural balance.
The study design is a randomised controlled trial in population with pronated feet. The aim
      of this study is to investigate the immediate effects of sole session of foot medial arch'
      NMES on foot strength, arch stability, static plantar pressure distribution and dynamic
      postural balance. This is the 2nd study to investigate the effect one session as previous
      study showed immediate effect on plantar pressure distribution on the midfoot and durable
      effect at 2 months follow-up. However, no studies investigated the effects on others
      parameters than plantar pressure.The general objective of our study is to question electrical
      stimulation as a modality for foot strengthening to enhance dynamic postural balance and foot
      functions.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be allocated to the intervention or control group using permuted block randomization with blocks of 4 or 6 patients on a 1:1 ratio.
primary purpose: Treatment
masking: Single (Participant)
masking description: This randomised controlled trial is in single blind. Participants will be informed about their treatment group after termination of the study.
measure: Foot strength
time frame: Before and immediately after intervention
description: The change of foot strength that will be measured on a pressure platform on the dominant foot before and after intervention (NMES or TENS). This primary outcome will be also measured on the non-dominant foot to assess cross effects.
measure: Dynamic postural balance
time frame: Before and immediately after intervention
description: The secondary outcomes include the change of dynamic postural balance in the posterior direction on the dominant foot. All measurements will be performed on the non-dominant foot to assess cross effects. To assess dynamic postural balance performance, we will use the Star Excursion Balance Test (SEBT). The star excursion balance test (SEBT) is a measure of dynamic balance with good to excellent test-retest reliability. The test will be conducted in the anterior, posterior-lateral and posterior-medial directions. The SEBT will be performed with the subject standing barefoot so that the distal end of the longest toe of the stance foot will be placed at the center of the grid. They will have to maintain a single-leg stance while reaching with the contralateral leg to touch as far as possible along the direction by a light touch. The reached distances will be normalized to the respective stance-limb length (anterior superior iliac spine to the inferior border of the medial malleolus).
measure: Arch stability
time frame: Before and immediately after intervention
description: The secondary outcomes include the change of arch stability on the dominant foot. This measurement will be performed on the non-dominant foot to assess cross effects. The sit-to-stand double-leg navicular drop test will be used to evaluate longitudinal arch stability. Participants will sit on a chair with their hips, knees, and ankles bent to 90° and the feet resting on the floor. The inferior border of the prominent tuberosity of the navicular bone will be palpated and marked with a pen. Next, the distance of the marked navicular point to the ground in a seated position will be measured using a steel ruler (resolution: 0.5 mm). Then, we will ask the subject to stand barefoot on a 4-in (10.16-cm) box, placing all weight on the foot being measured, while the other foot rested lightly on the box. Finally, the difference between the two measures (sitting - standing) will be calculated and defined as navicular drop (ND).
measure: Static plantar pressure distribution
time frame: Before and immediately after intervention
description: The secondary outcomes include the change of arch stability on the dominant foot. In this study the evaluation of the longitudinal arch of the foot will be made with the use of the Zebris FDM-S dynamometric platform. It will describe foot arch assessment based on the AI calculated on the basis of discretized measurements of distribution of forces on the ground, by means of the platform.
According to this theory, a static arch pressure index (SAPI) will be measured by utilizing the average/maximal foot pressure distribution during static single leg standing of 30 seconds with their arms along the body while the subject will have one foot on a Zebris platform. Based on distribution of pressure on the entire foot the SAPI will be calculate as the ratio of the midfoot pressure distribution relative to the whole foot pressure distribution excluding the toes.
arm group label: NMES group
arm group type: Experimental
description: For the NMES group one portable stimulator (Compex 2, Medicompex SA, Ecublens, Switzerland) will deliver NEMS (15 min; 75 EMS contractions completed during the training session; rise time = 0.25 s and descending time = 0.75 s). In order to maximize muscle tension without accompanying detrimental effects on fatigue onset, biphasic symmetric regular-wave pulsed currents (85 Hz) lasting 400 μs will be delivered. Each 4-s steady tetanic stimulation will be followed by pause lasting 8-s, during which subjects will be submaximally stimulated at 4 Hz on the medial arch muscles. According to the recommendations, the two electrodes are placed behind the head of the first metatarsal to stimulate the medial arch intrinsic muscles. The goal is to attain the highest tolerable level of muscle contraction without discomfort during the 15 minutes and to provide a full tetanic contraction of the intrinsic foot muscles during the contraction time.
arm group label: Control group
arm group type: Placebo Comparator
description: For the control group the one portable stimulator (Compex 2, Medicompex SA, Ecublens, Switzerland) will be used to apply a stimulation of 15 minutes considered by TENS at the lowest intensity detectable by the participant in order to not influence the outcomes of interest. Our aim is to strengthen IFM which is not the role of TENS. The two electrodes will be placed on the dominant foot, at the same place than those for the NMES group.
intervention type: Device
intervention name: NMES
description: Neuromuscular Electrical Stimulation (NMES) is a non pharmacological intervention that sends electrical impulses to nerves leading to muscle contraction. The electrical stimulation can increase strength and is often used to re-educate or re-train muscles.
arm group label: NMES group
intervention type: Device
intervention name: TENS
description: Transcutaneous electrical nerve stimulation (TENS) is a nonpharmacological intervention that activates a complex neuronal network to reduce pain by activating descending inhibitory systems in the central nervous system to reduce hyperalgesia.
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Boris Gojanovic, MD
role: Principal Investigator
affiliation: La Tour Hospital
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: La Tour Hospital
investigator full name: Boris Gojanovic
investigator title: Principal Investigator
sharing ipd: No