xml: <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/NCT05965336</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00004341</org_study_id>
      <secondary_id>K01HD107294</secondary_id>
      <nct_id>NCT05965336</nct_id>
    </id_info>
    <brief_title>Walking Function in Diabetic Peripheral Neuropathy</brief_title>
    <official_title>Walking Function in Individuals With Diabetic Peripheral Neuropathy: Biomechanical Mechanisms and Implications for Clinical Outcomes and Gait Retraining</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Emory University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Emory University</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to 1) examine the differences in walking function and movement&#xD;
        patterns between individuals with diabetic peripheral neuropathy and healthy adults with no&#xD;
        known conditions; 2) examine if receiving feedback on walking form will help change walking&#xD;
        patterns; and 3) examine the feasibility, safety, and preliminary effects of walking training&#xD;
        with feedback on walking function in individuals with diabetic peripheral neuropathy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Over 34 million adults in the United States are living with Diabetes Mellitus (DM). Diabetic&#xD;
        peripheral neuropathy (DPN) is the most common complication, affecting 50% of individuals&#xD;
        with DM. Consequences of DPN include reduced sensation and feedback from the foot and lower&#xD;
        limb and increased plantar pressures, predisposing patients to ulcers and lower extremity&#xD;
        amputation. Individuals with DPN experience decreased quality of life compared with their&#xD;
        healthy and non-neuropathic DM peers, and report problems with mobility, daily activities,&#xD;
        pain, and discomfort. Additionally, people with DPN display reduced functional ambulation,&#xD;
        step counts, and walking speed. Though increases in physical activity and functional capacity&#xD;
        have been associated with improvements in quality of life, DPN poses a unique challenge in&#xD;
        mitigating risk while pursuing traditional exercise and walking programs.&#xD;
  &#xD;
        Traditional gait training programs used to improve walking function may increase ulceration&#xD;
        risk, making these interventions unsuitable if not tailored for people with DPN. The goal of&#xD;
        this study is to elucidate the underlying biomechanical mechanisms contributing to the&#xD;
        inter-relationships between plantar pressure and propulsion in individuals with DPN, and to&#xD;
        examine the safety and feasibility of using real-time biofeedback to modify plantar pressure&#xD;
        and propulsion during gait.&#xD;
  &#xD;
        The aims of this study are to evaluate (1) biomechanical mechanisms contributing to abnormal&#xD;
        plantar pressure and propulsion during gait in individuals with DPN; (2) biofeedback-induced&#xD;
        changes in plantar pressure, propulsion, and biomechanics during gait in individuals with DPN&#xD;
        and age-similar controls; and (3) the acceptability, feasibility, safety, and preliminary&#xD;
        effects of gait training in individuals with DPN. Insights into the biomechanical mechanisms&#xD;
        underlying plantar pressure and propulsion in people with DPN will allow for the design of&#xD;
        more informed and effective gait rehabilitation interventions aimed at preventing deleterious&#xD;
        outcomes such as ulceration and amputation that can be tailored to individual patient&#xD;
        characteristics.&#xD;
  &#xD;
        Able-bodied participants will complete three experimental sessions and participants with DPN&#xD;
        will complete a total of seven experimental sessions. Each session will be approximately 2-3&#xD;
        hours in duration.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2027</completion_date>
    <primary_completion_date type="Anticipated">March 2027</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>Crossover Assignment</intervention_model>
      <intervention_model_description>To evaluate biofeedback-induced changes in plantar pressure, propulsion, and biomechanics during gait in individuals with DPN versus age-similar controls. Then, participants with DPN will will complete an additional four experimental sessions to collect data in a randomized crossover pilot clinical trial to examine the acceptability, feasibility, safety, and preliminary effects of gait biofeedback training in individuals with DPN.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Biomechanical plantar pressure</measure>
      <time_frame>Study Session 2 (occurs 24 hours up to 2 weeks after Day 1)</time_frame>
      <description>Plantar pressure is calculated in kilopascals (kPa) using a force sensor placed between the participant's foot and insole of their shoe. The peak plantar pressure in regions of interest (forefoot) will be calculated.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Biomechanical Propulsion</measure>
      <time_frame>Study Session 2 (occurs 24 hours up to 2 weeks after Day 1)</time_frame>
      <description>Propulsion is calculated as the maximum anteriorly directed ground reaction force during the stance phase of gait using the instrumented (force plate) treadmill.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Biomechanical modulation of ankle stiffness</measure>
      <time_frame>Study Session 2 (occurs 24 hours up to 2 weeks after Day 1)</time_frame>
      <description>Participants will walk for 3 minutes on a treadmill at their self-selected speed to enable stabilization of movement patterns, warmup, and preconditioning of lower extremity muscles prior to dynamometer tasks. Participants will then be seated in a dynamometer with their trunk and thigh stabilized to the dynamometer chair, ankle joint aligned with the rotational axis of the dynamometer, and foot stabilized to the foot plate. Electromyography (EMG) activity will be recorded from lower limb muscles during all isolated contractions. Participants will first perform three maximum voluntary isometric contractions (MVIC) while seated in a dynamometer. Participants will then perform three isokinetic dorsiflexion tasks while using electromyographic biofeedback at a prescribed level of 50% MVIC soleus activation. The slope of the linear best fit line from the ankle moment vs. angle plot will yield total ankle joint stiffness at a fixed activation.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes induced by biofeedback in plantar pressure</measure>
      <time_frame>Study sessions 4 (48 hours - 3 weeks after session 3), 5 (24-48 hours after session 4) , 6 (3 weeks after session 5) and 7 (24-48 hours after session 6)</time_frame>
      <description>Plantar pressure measurements will be recorded using insoles placed between the surface of the foot and the insole of the participant's shoe. Marker data, GRFs, and plantar pressure data will be synchronized.&#xD;
  Regression analysis will be used to examine plantar pressure during gait by study group.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes induced by biofeedback in propulsion</measure>
      <time_frame>Study sessions 4 (48 hours - 3 weeks after session 3), 5 (24-48 hours after session 4) , 6 (3 weeks after session 5) and 7 (24-48 hours after session 6)</time_frame>
      <description>Ground reaction force (GRF) data will be collected independently from each leg using a split-belt treadmill instrumented with two 6-degree of freedom force platforms. The antero-posterior GRFs (AGRF) will be used to compute propulsion.&#xD;
  Regression analysis will be used to examine propulsion during gait by study group.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes induced by biofeedback in biomechanics during gait</measure>
      <time_frame>Study sessions 4 (48 hours - 3 weeks after session 3), 5 (24-48 hours after session 4) , 6 (3 weeks after session 5) and 7 (24-48 hours after session 6)</time_frame>
      <description>Lower extremity kinetics and kinematics will be measured using a three-dimensional motion analysis system and split-belt instrumented treadmill. Kinetics and kinematics of the ankle, knee, and hip will be analyzed during gait.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Diabetic Peripheral Neuropathy</condition>
    <arm_group>
      <arm_group_label>Able-Bodied Participants</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Able-bodied participants will complete a total of three study sessions. The three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with participants with DPN.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with DPN will complete a total of seven study sessions. The first three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with able bodied participants. Sessions four through seven involve two different biofeedback training sessions followed by a retention gait analysis test 24-48 hours after training. Participants in this study are are randomized to receive plantar pressure biofeedback gait training first and propulsion biofeedback gait training at least three weeks later.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with DPN will complete a total of seven study sessions. The first three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with able bodied participants. Sessions four through seven involve two different biofeedback training sessions followed by a retention gait analysis test 24-48 hours after training. Participants in this study are are randomized to receive propulsion biofeedback gait training first and plantar pressure biofeedback gait training at least three weeks later.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Clinical Evaluation</intervention_name>
      <description>A clinical evaluation occurs at the first study session. The clinical evaluation assesses walking function and mobility, lower extremity, sensation, health-related quality of life (HRQoL) and foot function.&#xD;
  Session 2 will be a dynamometer-based evaluation of passive ankle stiffness and 3-dimensional gait analysis to evaluate baseline biomechanics. During Session 3, real-time biofeedback conditions will be used to measure the immediate effects on walking function.</description>
      <arm_group_label>Able-Bodied Participants</arm_group_label>
      <arm_group_label>Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training</arm_group_label>
      <arm_group_label>Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Evaluation of Passive Ankle Stiffness</intervention_name>
      <description>Participants will be seated in a dynamometer with their trunk and thigh stabilized to the dynamometer chair, ankle joint aligned with the rotational axis of the dynamometer, and foot stabilized to the foot plate. EMG activity will be recorded from lower limb muscles (gastrocnemius, soleus, tibialis anterior) during all isolated contractions. Participants will first perform three maximum voluntary isometric contractions (MVIC) while seated in a dynamometer. Participants will then perform three isokinetic dorsiflexion tasks while using electromyographic biofeedback at a prescribed level of 50% MVIC soleus activation. The slope of the linear best fit line from the ankle moment vs. angle plot will yield total ankle joint stiffness (i.e., active + passive) at a fixed activation. In three additional trials, the dynamometer will move the ankle joint through the same motion without active subject resistance and the same analytical procedures will derive passive ankle joint stiffness.</description>
      <arm_group_label>Able-Bodied Participants</arm_group_label>
      <arm_group_label>Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training</arm_group_label>
      <arm_group_label>Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Gait Biomechanics</intervention_name>
      <description>Three-dimensional gait analysis is performed as participants walk at a self-selected speed on an instrumented treadmill. Reflective markers are attached to lower extremity segments. Elastic bands are wrapped around the thighs, calves, and pelvis to which small, thermoplastic shells containing reflective markers are attached. Additional markers are taped to the participant's shoes and on the upper back, shoulder, hip, knee, and ankle joints with adhesive skin tape. Marker data is collected using a 7-camera motion analysis system (Vicon Inc., USA). Vicon motion analysis cameras will collect the location of the retroreflective markers in Vicon Nexus software.</description>
      <arm_group_label>Able-Bodied Participants</arm_group_label>
      <arm_group_label>Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training</arm_group_label>
      <arm_group_label>Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Gait Biofeedback</intervention_name>
      <description>Audio-visual biofeedback will be provided using a screen placed in front of the treadmill and a speaker. For plantar pressure biofeedback, a visual display of a foot with a colored heat map will represent the current plantar pressure, in addition to bar graphs representing real-time movement of plantar pressure in specific areas of the foot. A target will be provided using the heat map colors of red and target line on the bar graph. For propulsion biofeedback, a visual display with a marker will represent the current propulsion (peak AGRF) and a target provided to modulate propulsion. The plantar pressure and AGRF measurements from the participant's baseline walking trials will be used to determine customized biofeedback targets.</description>
      <arm_group_label>Able-Bodied Participants</arm_group_label>
      <arm_group_label>Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training</arm_group_label>
      <arm_group_label>Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Plantar Pressure Biofeedback Gait Training</intervention_name>
      <description>Participants will complete a 3-dimensional gait evaluation prior to training, after a 6-minute control bout without biofeedback, and following three 6-minute biofeedback training bouts (total 18-minutes). Individualized biofeedback targets will be calculated from each participant's immediate biofeedback session to best minimize plantar pressure whilst maintaining or enhancing propulsion. Audio-visual biofeedback is provided using a screen placed in front of the treadmill and a speaker. For plantar pressure biofeedback, a visual display of a foot with a colored heat map represents the current plantar pressure, in addition to bar graphs representing real-time movement of plantar pressure in specific areas of the foot. A target is provided using the heat map colors of red and target line on the bar graph. Participants are informed that the target is a measurement of the pressure under their foot, and their goal is to decrease pressure to achieve their target.</description>
      <arm_group_label>Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training</arm_group_label>
      <arm_group_label>Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Propulsion Biofeedback Gait Training</intervention_name>
      <description>Participants will complete a 3-dimensional gait evaluation prior to training, after a 6-minute control bout without biofeedback, and following three 6-minute biofeedback training bouts (total 18-minutes). Individualized biofeedback targets will be calculated from each participant's immediate biofeedback session to best minimize plantar pressure whilst maintaining or enhancing propulsion. Audio-visual biofeedback is provided using a screen placed in front of the treadmill and a speaker. For propulsion biofeedback, a visual display with a marker represents the current propulsion (peak AGRF) and a target provided to modulate propulsion. Participants are informed that the marker is a measurement of how hard they are pushing the ground backward, and their goal is to push-off more to achieve their target.</description>
      <arm_group_label>Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training</arm_group_label>
      <arm_group_label>Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria for All Participants:&#xD;
  &#xD;
            1. Age 45+ years&#xD;
  &#xD;
            2. Able to walk 10-meters independently without an assistive device&#xD;
  &#xD;
            3. Sufficient cardiovascular and musculoskeletal health to walk on a treadmill for&#xD;
               1-minute at self-selected speed&#xD;
  &#xD;
          Inclusion Criteria for Participants with DPN:&#xD;
  &#xD;
            1. Diagnosis of DM&#xD;
  &#xD;
            2. Diagnosis of DPN by a physician&#xD;
  &#xD;
            3. Foot examination within the past 6 months to document ambulatory status&#xD;
  &#xD;
            4. Physician's clearance&#xD;
  &#xD;
          Exclusion Criteria for Healthy Able-Bodied Individuals:&#xD;
  &#xD;
            1. History of neurologic disease&#xD;
  &#xD;
            2. History of orthopaedic disease affecting the lower extremities&#xD;
  &#xD;
            3. History of injury or pain affecting the lower extremity or walking function within the&#xD;
               past 6 months&#xD;
  &#xD;
          Exclusion Criteria for All Participants:&#xD;
  &#xD;
            1. History of amputation&#xD;
  &#xD;
            2. Active ulceration&#xD;
  &#xD;
            3. Medial column deformity&#xD;
  &#xD;
            4. History of Charcot osteoarthropathy&#xD;
  &#xD;
            5. History of posterior muscle group lengthening&#xD;
  &#xD;
            6. History of lower extremity joint replacement&#xD;
  &#xD;
            7. History of lower extremity and/or foot surgery affecting walking mechanics&#xD;
  &#xD;
            8. Orthopaedic problems of the lower limbs or spine due to other medical conditions (not&#xD;
               DM or DPN) that limit walking or cause pain during walking&#xD;
  &#xD;
            9. Improper footwear for walking and community ambulation&#xD;
  &#xD;
           10. Cardiovascular or medical condition affecting ability to walk safely&#xD;
  &#xD;
           11. History of unexplained dizziness or fainting in the past 2 months&#xD;
  &#xD;
           12. Allergy to adhesive tape or rubbing alcohol&#xD;
  &#xD;
           13. Individuals who are pregnant, prisoners, or not yet adults&#xD;
  &#xD;
           14. Inability to communicate with the investigators&#xD;
  &#xD;
           15. Inability to provide written informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nicole Rendos, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assistant Professor</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nicole Rendos, PhD</last_name>
      <phone>(404) 860-2826</phone>
      <email>nrendos@emory.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Grady Memorial Hospital</name>
        <address>
          <city>Atlanta</city>
          <state>Georgia</state>
          <zip>30303</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Paulina Rebolledo, MD</last_name>
        <phone>404-251-8855</phone>
        <email>preboll@emory.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Emory Rehabilitation Hospital</name>
        <address>
          <city>Atlanta</city>
          <state>Georgia</state>
          <zip>30322</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Nicole Rendos, PhD</last_name>
        <phone>404-860-2826</phone>
        <email>nrendos@emory.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Emory University</investigator_affiliation>
      <investigator_full_name>Nicole Rendos</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Diabetes</keyword>
    <keyword>Biofeedback-induced changes</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Peripheral Nervous System Diseases</mesh_term>
      <mesh_term>Diabetic Neuropathies</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Individual participant data that underlie published results will be made available for sharing with other researchers after de-identification.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Data will be available beginning 12 months and ending 36 months following publication of the the findings from this study.</ipd_time_frame>
      <ipd_access_criteria>Data will be available to be shared with scientific and clinical collaborators, clinical and research communities, for individual participant data meta-analyses. Requests should be directed to nrendos@emory.edu and may be submitted up to 36 months following publication of this study. To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05965336
  org study id: STUDY00004341
  secondary id: K01HD107294
  nct id: NCT05965336
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to 1) examine the differences in walking function and movement
        patterns between individuals with diabetic peripheral neuropathy and healthy adults with no
        known conditions; 2) examine if receiving feedback on walking form will help change walking
        patterns; and 3) examine the feasibility, safety, and preliminary effects of walking training
        with feedback on walking function in individuals with diabetic peripheral neuropathy.
  Over 34 million adults in the United States are living with Diabetes Mellitus (DM). Diabetic
        peripheral neuropathy (DPN) is the most common complication, affecting 50% of individuals
        with DM. Consequences of DPN include reduced sensation and feedback from the foot and lower
        limb and increased plantar pressures, predisposing patients to ulcers and lower extremity
        amputation. Individuals with DPN experience decreased quality of life compared with their
        healthy and non-neuropathic DM peers, and report problems with mobility, daily activities,
        pain, and discomfort. Additionally, people with DPN display reduced functional ambulation,
        step counts, and walking speed. Though increases in physical activity and functional capacity
        have been associated with improvements in quality of life, DPN poses a unique challenge in
        mitigating risk while pursuing traditional exercise and walking programs.
  
        Traditional gait training programs used to improve walking function may increase ulceration
        risk, making these interventions unsuitable if not tailored for people with DPN. The goal of
        this study is to elucidate the underlying biomechanical mechanisms contributing to the
        inter-relationships between plantar pressure and propulsion in individuals with DPN, and to
        examine the safety and feasibility of using real-time biofeedback to modify plantar pressure
        and propulsion during gait.
  
        The aims of this study are to evaluate (1) biomechanical mechanisms contributing to abnormal
        plantar pressure and propulsion during gait in individuals with DPN; (2) biofeedback-induced
        changes in plantar pressure, propulsion, and biomechanics during gait in individuals with DPN
        and age-similar controls; and (3) the acceptability, feasibility, safety, and preliminary
        effects of gait training in individuals with DPN. Insights into the biomechanical mechanisms
        underlying plantar pressure and propulsion in people with DPN will allow for the design of
        more informed and effective gait rehabilitation interventions aimed at preventing deleterious
        outcomes such as ulceration and amputation that can be tailored to individual patient
        characteristics.
  
        Able-bodied participants will complete three experimental sessions and participants with DPN
        will complete a total of seven experimental sessions. Each session will be approximately 2-3
        hours in duration.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: To evaluate biofeedback-induced changes in plantar pressure, propulsion, and biomechanics during gait in individuals with DPN versus age-similar controls. Then, participants with DPN will will complete an additional four experimental sessions to collect data in a randomized crossover pilot clinical trial to examine the acceptability, feasibility, safety, and preliminary effects of gait biofeedback training in individuals with DPN.
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Biomechanical plantar pressure
  time frame: Study Session 2 (occurs 24 hours up to 2 weeks after Day 1)
  description: Plantar pressure is calculated in kilopascals (kPa) using a force sensor placed between the participant's foot and insole of their shoe. The peak plantar pressure in regions of interest (forefoot) will be calculated.
  measure: Biomechanical Propulsion
  time frame: Study Session 2 (occurs 24 hours up to 2 weeks after Day 1)
  description: Propulsion is calculated as the maximum anteriorly directed ground reaction force during the stance phase of gait using the instrumented (force plate) treadmill.
  measure: Biomechanical modulation of ankle stiffness
  time frame: Study Session 2 (occurs 24 hours up to 2 weeks after Day 1)
  description: Participants will walk for 3 minutes on a treadmill at their self-selected speed to enable stabilization of movement patterns, warmup, and preconditioning of lower extremity muscles prior to dynamometer tasks. Participants will then be seated in a dynamometer with their trunk and thigh stabilized to the dynamometer chair, ankle joint aligned with the rotational axis of the dynamometer, and foot stabilized to the foot plate. Electromyography (EMG) activity will be recorded from lower limb muscles during all isolated contractions. Participants will first perform three maximum voluntary isometric contractions (MVIC) while seated in a dynamometer. Participants will then perform three isokinetic dorsiflexion tasks while using electromyographic biofeedback at a prescribed level of 50% MVIC soleus activation. The slope of the linear best fit line from the ankle moment vs. angle plot will yield total ankle joint stiffness at a fixed activation.
  measure: Changes induced by biofeedback in plantar pressure
  time frame: Study sessions 4 (48 hours - 3 weeks after session 3), 5 (24-48 hours after session 4) , 6 (3 weeks after session 5) and 7 (24-48 hours after session 6)
  description: Plantar pressure measurements will be recorded using insoles placed between the surface of the foot and the insole of the participant's shoe. Marker data, GRFs, and plantar pressure data will be synchronized.
  Regression analysis will be used to examine plantar pressure during gait by study group.
  measure: Changes induced by biofeedback in propulsion
  time frame: Study sessions 4 (48 hours - 3 weeks after session 3), 5 (24-48 hours after session 4) , 6 (3 weeks after session 5) and 7 (24-48 hours after session 6)
  description: Ground reaction force (GRF) data will be collected independently from each leg using a split-belt treadmill instrumented with two 6-degree of freedom force platforms. The antero-posterior GRFs (AGRF) will be used to compute propulsion.
  Regression analysis will be used to examine propulsion during gait by study group.
  measure: Changes induced by biofeedback in biomechanics during gait
  time frame: Study sessions 4 (48 hours - 3 weeks after session 3), 5 (24-48 hours after session 4) , 6 (3 weeks after session 5) and 7 (24-48 hours after session 6)
  description: Lower extremity kinetics and kinematics will be measured using a three-dimensional motion analysis system and split-belt instrumented treadmill. Kinetics and kinematics of the ankle, knee, and hip will be analyzed during gait.
  arm group label: Able-Bodied Participants
  arm group type: Active Comparator
  description: Able-bodied participants will complete a total of three study sessions. The three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with participants with DPN.
  arm group label: Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training
  arm group type: Experimental
  description: Participants with DPN will complete a total of seven study sessions. The first three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with able bodied participants. Sessions four through seven involve two different biofeedback training sessions followed by a retention gait analysis test 24-48 hours after training. Participants in this study are are randomized to receive plantar pressure biofeedback gait training first and propulsion biofeedback gait training at least three weeks later.
  arm group label: Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training
  arm group type: Experimental
  description: Participants with DPN will complete a total of seven study sessions. The first three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with able bodied participants. Sessions four through seven involve two different biofeedback training sessions followed by a retention gait analysis test 24-48 hours after training. Participants in this study are are randomized to receive propulsion biofeedback gait training first and plantar pressure biofeedback gait training at least three weeks later.
  intervention type: Other
  intervention name: Clinical Evaluation
  description: A clinical evaluation occurs at the first study session. The clinical evaluation assesses walking function and mobility, lower extremity, sensation, health-related quality of life (HRQoL) and foot function.
  Session 2 will be a dynamometer-based evaluation of passive ankle stiffness and 3-dimensional gait analysis to evaluate baseline biomechanics. During Session 3, real-time biofeedback conditions will be used to measure the immediate effects on walking function.
  arm group label: Able-Bodied Participants
  arm group label: Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training
  arm group label: Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training
  intervention type: Other
  intervention name: Evaluation of Passive Ankle Stiffness
  description: Participants will be seated in a dynamometer with their trunk and thigh stabilized to the dynamometer chair, ankle joint aligned with the rotational axis of the dynamometer, and foot stabilized to the foot plate. EMG activity will be recorded from lower limb muscles (gastrocnemius, soleus, tibialis anterior) during all isolated contractions. Participants will first perform three maximum voluntary isometric contractions (MVIC) while seated in a dynamometer. Participants will then perform three isokinetic dorsiflexion tasks while using electromyographic biofeedback at a prescribed level of 50% MVIC soleus activation. The slope of the linear best fit line from the ankle moment vs. angle plot will yield total ankle joint stiffness (i.e., active + passive) at a fixed activation. In three additional trials, the dynamometer will move the ankle joint through the same motion without active subject resistance and the same analytical procedures will derive passive ankle joint stiffness.
  arm group label: Able-Bodied Participants
  arm group label: Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training
  arm group label: Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training
  intervention type: Other
  intervention name: Gait Biomechanics
  description: Three-dimensional gait analysis is performed as participants walk at a self-selected speed on an instrumented treadmill. Reflective markers are attached to lower extremity segments. Elastic bands are wrapped around the thighs, calves, and pelvis to which small, thermoplastic shells containing reflective markers are attached. Additional markers are taped to the participant's shoes and on the upper back, shoulder, hip, knee, and ankle joints with adhesive skin tape. Marker data is collected using a 7-camera motion analysis system (Vicon Inc., USA). Vicon motion analysis cameras will collect the location of the retroreflective markers in Vicon Nexus software.
  arm group label: Able-Bodied Participants
  arm group label: Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training
  arm group label: Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training
  intervention type: Other
  intervention name: Gait Biofeedback
  description: Audio-visual biofeedback will be provided using a screen placed in front of the treadmill and a speaker. For plantar pressure biofeedback, a visual display of a foot with a colored heat map will represent the current plantar pressure, in addition to bar graphs representing real-time movement of plantar pressure in specific areas of the foot. A target will be provided using the heat map colors of red and target line on the bar graph. For propulsion biofeedback, a visual display with a marker will represent the current propulsion (peak AGRF) and a target provided to modulate propulsion. The plantar pressure and AGRF measurements from the participant's baseline walking trials will be used to determine customized biofeedback targets.
  arm group label: Able-Bodied Participants
  arm group label: Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training
  arm group label: Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training
  intervention type: Other
  intervention name: Plantar Pressure Biofeedback Gait Training
  description: Participants will complete a 3-dimensional gait evaluation prior to training, after a 6-minute control bout without biofeedback, and following three 6-minute biofeedback training bouts (total 18-minutes). Individualized biofeedback targets will be calculated from each participant's immediate biofeedback session to best minimize plantar pressure whilst maintaining or enhancing propulsion. Audio-visual biofeedback is provided using a screen placed in front of the treadmill and a speaker. For plantar pressure biofeedback, a visual display of a foot with a colored heat map represents the current plantar pressure, in addition to bar graphs representing real-time movement of plantar pressure in specific areas of the foot. A target is provided using the heat map colors of red and target line on the bar graph. Participants are informed that the target is a measurement of the pressure under their foot, and their goal is to decrease pressure to achieve their target.
  arm group label: Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training
  arm group label: Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training
  intervention type: Other
  intervention name: Propulsion Biofeedback Gait Training
  description: Participants will complete a 3-dimensional gait evaluation prior to training, after a 6-minute control bout without biofeedback, and following three 6-minute biofeedback training bouts (total 18-minutes). Individualized biofeedback targets will be calculated from each participant's immediate biofeedback session to best minimize plantar pressure whilst maintaining or enhancing propulsion. Audio-visual biofeedback is provided using a screen placed in front of the treadmill and a speaker. For propulsion biofeedback, a visual display with a marker represents the current propulsion (peak AGRF) and a target provided to modulate propulsion. Participants are informed that the marker is a measurement of how hard they are pushing the ground backward, and their goal is to push-off more to achieve their target.
  arm group label: Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training
  arm group label: Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training
  criteria: 
  gender: All
  minimum age: 45 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Nicole Rendos, PhD
  role: Principal Investigator
  affiliation: Assistant Professor
  last name: Nicole Rendos, PhD
  phone: (404) 860-2826
  email: nrendos@emory.edu
  facility: 
  contact: 
  facility: 
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Emory University
  investigator full name: Nicole Rendos
  investigator title: Assistant Professor
  mesh term: Peripheral Nervous System Diseases
  mesh term: Diabetic Neuropathies
  sharing ipd: Yes
  ipd description: Individual participant data that underlie published results will be made available for sharing with other researchers after de-identification.
  ipd info type: Study Protocol
  ipd time frame: Data will be available beginning 12 months and ending 36 months following publication of the the findings from this study.
  ipd access criteria: Data will be available to be shared with scientific and clinical collaborators, clinical and research communities, for individual participant data meta-analyses. Requests should be directed to nrendos@emory.edu and may be submitted up to 36 months following publication of this study. To gain access, data requestors will need to sign a data access agreement.