<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/NCT02227407</url>
  </required_header>
  <id_info>
    <org_study_id>201305047RINC</org_study_id>
    <secondary_id>200703061R</secondary_id>
    <nct_id>NCT02227407</nct_id>
  </id_info>
  <brief_title>Reciprocating Gait Orthoses for Paraplegia Patients</brief_title>
  <acronym>UPGO</acronym>
  <official_title>NSC Assistive Technology Research: Reciprocating Gait Orthoses for Paraplegia Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Science Council, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ambulation would bring many physiological and psychological benefits and getting up and&#xD;
      walking has been a dream for paraplegia patients.The reciprocating gait orthoses (RGOs) for&#xD;
      paraplegics particularly draws research attentions because it mimics human gait pattern.But,&#xD;
      the high energy consumption and low walking speeds caused the frequent abandonment or the low&#xD;
      utilization of the reciprocating gait orthoses.To improve the design reducing the energy&#xD;
      expenditure, it requires biomechanical analysis of the pathological gait such that the gait&#xD;
      deviations and energy consuming mechanisms can be identified and remedial means can be&#xD;
      implemented.&#xD;
&#xD;
      The investigators hypotheses will include that there would exist an energy saving mechanism&#xD;
      of human reciprocating locomotion based on the principle of conservation of mechanical&#xD;
      energy.Secondly, kinematic and kinetic gait determinants could be derived from the energy&#xD;
      saving mechanism. Finally, the control of knee joint coordinating with the hip joint&#xD;
      movements would facilitate the gait progression and further reduce the energy consumption.&#xD;
&#xD;
      The objective of this clinical trial is to evaluate the gait of paraplegic patients with&#xD;
      reciprocating gait orthoses and to support the investigators research in biomechanical&#xD;
      analysis, design and control of reciprocating gait orthoses for paraplegia patients. An&#xD;
      experiment to study the pathological gait of paraplegia patients with an existing&#xD;
      reciprocating gait orthosis will be carried out.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Ambulation is a rehabilitation priority for many paraplegic patients, either for&#xD;
      the psychological reasons or with the aim to achieve partial or full independence. It also&#xD;
      provides the therapeutic benefits which are widely acknowledged to improve urinary drainage,&#xD;
      to improve peripheral circulation, and to prevent the complication caused from bedridden,&#xD;
      such as contracture, osteoporosis, urinary tract infection, and constipation etc. Some&#xD;
      studies also found that ambulation will increase cardiopulmonary function. For those&#xD;
      pediatric spinal cord-injured patients, the upright posture also profits the development of&#xD;
      trunk and head control. There are a number of reciprocating gait orthoses (RGOs) available in&#xD;
      practice for paraplegics, the problems of which have been slow, heavy and high&#xD;
      energy-consumption. The biomechanical causes are not fully understood. Despite all the&#xD;
      benefits that RGOs can offer, research and clinical experience indicated that most paraplegia&#xD;
      patients choose wheelchair mobility after discharge to the community because it is faster,&#xD;
      safer and needs less energy expenditure. Therefore, a biomechanical study of the pathological&#xD;
      gait of paraplegia patients with RGOs is critically needed. The problems of currently applied&#xD;
      RGOs need to be analyzed and remedial means to be proposed. In addition, a new RGOs system is&#xD;
      also needed to serve as a research tool and a platform proving the remedial ideas.&#xD;
&#xD;
      Literature Review: There are many kinds of gait orthoses prescribed for paraplegics, which&#xD;
      can be grouped according to the patterns of propulsion. The first type is a group of&#xD;
      swing-through gait orthoses which include the Knee-Ankle-Foot orthoses (KAFO),&#xD;
      Hip-Knee-Ankle-Foot orthoses (HKAFO), and the parapodium. The swing-through gait has high&#xD;
      energy cost and users give up the orthoses easily. Swivel walkers belong to the second group,&#xD;
      which enables paraplegic patients to ambulate in an upright position without the use of&#xD;
      crutches or other walking aids. Patients progress by shifting the center of gravity; and&#xD;
      increase the walking speed by swing their arms and by the rotation of the trunk. Loretta et&#xD;
      al. compared the swivel gait with the swing gait, which shows the swivel gait has slower&#xD;
      speed but more efficient gait which implies that lower metabolic cost and oxygen consumption&#xD;
      are needed. Although the swivel walker has the advantages of providing low energy and&#xD;
      hand-free walking, it was most criticized for its low walking speed and for its inability to&#xD;
      ambulate on an uneven surface. The third one is a group of reciprocating gait orthoses which&#xD;
      were developed with a belief that they would provide a more energy efficient gait than other&#xD;
      gait orthoses. The LSU RGOs developed in the early 1980's has hip joints that are linked to&#xD;
      act in a reciprocal pattern. In the early 1990s, there were two revised version of the LSU&#xD;
      RGOs developed, ARGOs (Advanced RGOs using one cable and IRGOs (Isocentric RGOs) using a&#xD;
      solid rocker bar. The hip guidance orthosis (HGOs) that provides friction-free hip joint also&#xD;
      allows patients to walk reciprocally. WO, walkabout orthosis, is an infraperineal structure&#xD;
      that also facilitates reciprocating walking. Comparing with HKAFO, RGOs was heavier, slower,&#xD;
      and the energy cost (mL/kg/m) was higher although the energy consumption rate (mL/kg/min) was&#xD;
      significantly higher for children in HKAFOs.&#xD;
&#xD;
      To achieve an efficient gait and to overcome the problem to be slow, the hybrid system, that&#xD;
      is the combination of the FES and RGOs , had shown the possibility for improvement. Because&#xD;
      this system used both the RGOs structural stability and muscle power stimulated by FES to&#xD;
      decrease the activity of the trunk muscles in prevention from fatigue, it can provide more&#xD;
      energy-efficient gait that increases the aerobic-anaerobic threshold of the patients in the&#xD;
      long term.&#xD;
&#xD;
      Many orthotic options for paraplegia are available but only to provide limited walking&#xD;
      functions with great energy consumption, which has been the reason for the frequent&#xD;
      abandonment or the low utilization of the RGOs. To improve the design reducing the energy&#xD;
      expenditure, it requires biomechanical analysis of the pathological gait such that the gait&#xD;
      deviations and energy consuming mechanisms can be identified and remedial means can be&#xD;
      implemented. There has been a recent research on the biomechanical analysis of an ARGOs&#xD;
      user's gait and some possible mechanisms contributing to the high energy consumption were&#xD;
      discussed. However, no further remedial action in terms of design parameters was suggested in&#xD;
      their work. It is obvious that more research on the biomechanical study are needed to advance&#xD;
      the development of orthotic solutions for paraplegia patients.&#xD;
&#xD;
      Gait determinants were to identify the sources which affect the energy expenditure. The&#xD;
      determinants include pelvic rotation, pelvic list, knee flexion at mid-stance, foot and ankle&#xD;
      motion, knee motion and lateral pelvic displacement. There were studies to evaluate the&#xD;
      effects of these kinematic gait determinants on reduction of the vertical displacement of the&#xD;
      Body Center of mass (BCOM). Gard and Childress found that the magnitude of the trunk's&#xD;
      vertical excursion was virtually unaffected by pelvic list. Kerrigan pointed out the there&#xD;
      are other primary gait determinants needed to explain the actual reduction in BCOM vertical&#xD;
      displacement. A reduction of BCOM vertical excursion may have significant energy&#xD;
      implications, but it requires kinetic consideration to prove the gait determinants do affect&#xD;
      the energy expenditure.&#xD;
&#xD;
      Kinetic consideration was given in studies to the analysis of mechanical energy emphasizing&#xD;
      the exchange between potential and kinetic energy. A study of normal subjects suggested a&#xD;
      greater exchange between potential and kinetic energy near individually preferred walking&#xD;
      speeds. Since it was previously found that the self-selected speed minimizes the energy cost,&#xD;
      it can be readily induced that the normal gait with lower energy cost implies a greater&#xD;
      conservation of mechanical energy, i.e., a greater exchange between potential and kinetic&#xD;
      energy. It remains unclear as to what roles the gait determinants play in conserving the&#xD;
      mechanical energy.&#xD;
&#xD;
      In addition, joint biomechanics in the dynamic coordination particularly could never be&#xD;
      overemphasized when the energy consumption during ambulation is concerned. Gait efficiency in&#xD;
      terms of energy cost for ankle fusion patients reached 90% but the hip fusion patients&#xD;
      achieved only a 53% gait efficiency. The ankle fusion does not require major compensatory&#xD;
      movements in the gait pattern but only local substitutions in mid and forefoot areas were&#xD;
      observed. When the hip and the knee were disturbed, patients require pay in energy&#xD;
      consumption and compensatory substitutions for the lost function in the hip and the knee. It&#xD;
      implies that coordination of the knee and the hip has higher priority than the ankle and&#xD;
      human coordinating knee and hip movements could negotiate fairly well even with ankle&#xD;
      disturbance in walking to maintain energy consumption and speeds.&#xD;
&#xD;
      A hybrid orthosis system (HOS) has been being studied for walking after spinal-cord injury&#xD;
      (SCI), which coordinates the mechanical locking and unlocking of knee and ankle joints of a&#xD;
      reciprocating gait orthoses, while propulsive forces are injected and unlocked joints&#xD;
      controlled with functional neuromuscular stimulation. A feasibility study was carried out for&#xD;
      a functional neuromuscular stimulation powered mechanical gait orthosis with coordinated&#xD;
      joint locking (stance control KAFO). A laboratory hybrid RGOs was developed using a HKAFO&#xD;
      which contains controllable friction brakes at both hip and knee joints. A&#xD;
      computer-controlled orthosis system has been developed to address the problems of rapid&#xD;
      muscle fatigue and poor movement control that are characteristic of FES-aided gait. However,&#xD;
      the theme was not on the hip and knee coordination. In order that the coordination of hip and&#xD;
      knee joints can be studied, a computer simulation and experiment validation are necessary.&#xD;
      Therefore, a research tool needs to be developed so that a study can be conducted on the&#xD;
      effectiveness of the knee and hip coordination on the reduction of energy expenditure during&#xD;
      ambulation in paraplegia patients with reciprocating gait orthoses.&#xD;
&#xD;
      Research Objectives: In this research, the investigators hypotheses will include that there&#xD;
      would exist an energy saving mechanism of human reciprocating locomotion based on the&#xD;
      principle of conservation of mechanical energy.Secondly, kinematic and kinetic gait&#xD;
      determinants could be derived from the energy saving mechanism. Finally, the control of knee&#xD;
      joint coordinating with the hip joint movements would facilitate the gait progression and&#xD;
      further reduce the energy consumption.&#xD;
&#xD;
      Experimental equipments, devices and protocols: The patient evaluation, RGOs design and&#xD;
      fabrication, and fitting will be done under supervision of qualified orthotists in the&#xD;
      Rehabilitation Engineering Research Center at National Taiwan University (NTURERC). A Cosmed&#xD;
      K4b2 portable gas analysis system will be used to acquire physiological measures such as&#xD;
      heart rates and oxygen consumption. A three dimensional motion measurement system (Optotrak®&#xD;
      Certus™, Northern Digital Inc., Waterloo, Ontario, Canada) with two position sensors, each&#xD;
      with three cameras, will be used to collect kinematic data. Twelve rigid bodies with active&#xD;
      markers will be attached on the segments of subjects of the left upper arms, thighs, shanks,&#xD;
      heels, and the pelvis and the trunk. Eight force plates (AMTI) will be used to calculate the&#xD;
      kinetics of the segments of the lower limbs when using assistance. Participants will be given&#xD;
      instructions for the experiment. Patient's medical data such as diagnosis, onset, birth date,&#xD;
      gender, height and weight will be taken and basic data of normal subjects' will be collected&#xD;
      as well. Paraplegic subjects will walk at their self selected speeds and complete at least&#xD;
      three trials. The kinematic and kinetic data will be collected synchronously. Patients will&#xD;
      be asked to walk at their self selected speed for 30 meters along a designated route three&#xD;
      times in order to measure heart rates and oxygen consumption.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2013</start_date>
  <completion_date type="Anticipated">January 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the difference of joint kinetic data in able-bodied subjects and RGO users</measure>
    <time_frame>baseline, 30 minutes after fitting of the RGOs</time_frame>
    <description>joint force, joint moment and joint power during gait</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the difference of gait parameter in able-bodied subjects and RGO users</measure>
    <time_frame>baseline, 30 minutes after fitting of the RGOs</time_frame>
    <description>stride length, gait cycle period, gait speed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the difference of joint kinematic data in able-bodies subjects and RGO users</measure>
    <time_frame>baseline, 30 minutes after fitting of the RGOs</time_frame>
    <description>joint angle, joint excursion, joint angular velocity and acceleration</description>
  </secondary_outcome>
  <other_outcome>
    <measure>the difference of energy flow in able-bodied subjects and RGO users</measure>
    <time_frame>baseline, 30 minutes after fitting of the RGOs</time_frame>
    <description>measurement of the joint and segmental mechanical energy transfer during gait while using orthoses</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">8</enrollment>
  <condition>Myelomeningocele</condition>
  <condition>Spinal Cord Injury</condition>
  <condition>Spinal Muscular Atrophy</condition>
  <arm_group>
    <arm_group_label>Energy expenditure, gait pattern, RGOs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>using motion capture system and forceplates to monitor gait pattern while wearing reciprocating gait orthoses to calculate the mechanical energy cost</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RGOs(reciprocating gait orthoses)</intervention_name>
    <description>using additional apparatus combined with Hip-Knee-Ankle-Foot orthoses (HKAFO) to help paraplegia patients to present reciprocating gait pattern</description>
    <arm_group_label>Energy expenditure, gait pattern, RGOs</arm_group_label>
    <other_name>other name:HKAFO(Hip-Knee-Ankle-Foot orthoses)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  myelomeningocele or spinal cord injured patients at neurological level of T10-L2).&#xD;
&#xD;
          -  they should be walking with RGO for at least 30 meters (assistant device if needed).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  spasticity, contractures, and recurrent lower limb injuries&#xD;
&#xD;
          -  other neuromuscular disease&#xD;
&#xD;
          -  insufficient walking ability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Liang-Wey Chang, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rehabilitation Engineering Lab,NTU</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Liang-Wey Chang, Ph.D</last_name>
    <phone>+886-2-3366-3298</phone>
    <email>bmechlw@ntu.edu.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sheng-Ming Huang, Master</last_name>
    <phone>+886-2-3365-3368</phone>
    <phone_ext>101</phone_ext>
    <email>odrow.lin@msa.hinet.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Rehabilitation Engineering Research Center</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liang-Wey Chang, P.h.D.</last_name>
      <phone>+886-2-3366-3298</phone>
      <email>bmechlw@ntu.edu.tw</email>
    </contact>
    <contact_backup>
      <last_name>Sheng-Ming Huang, master</last_name>
      <phone>+886-910-947-955</phone>
      <email>odrow.lin@msa.hinet.net</email>
    </contact_backup>
    <investigator>
      <last_name>Liang-Wey Chang, P.h.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>April 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>August 26, 2014</last_update_submitted>
  <last_update_submitted_qc>August 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 28, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SCI</keyword>
  <keyword>SMA</keyword>
  <keyword>Paralysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Muscular Atrophy</mesh_term>
    <mesh_term>Muscular Atrophy, Spinal</mesh_term>
    <mesh_term>Paraplegia</mesh_term>
    <mesh_term>Meningomyelocele</mesh_term>
    <mesh_term>Spina Bifida Cystica</mesh_term>
  </condition_browse>
  <!-- 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/NCT02227407
org study id: 201305047RINC
secondary id: 200703061R
nct id: NCT02227407
lead sponsor: 
collaborator: 
has dmc: Yes
Ambulation would bring many physiological and psychological benefits and getting up and
      walking has been a dream for paraplegia patients.The reciprocating gait orthoses (RGOs) for
      paraplegics particularly draws research attentions because it mimics human gait pattern.But,
      the high energy consumption and low walking speeds caused the frequent abandonment or the low
      utilization of the reciprocating gait orthoses.To improve the design reducing the energy
      expenditure, it requires biomechanical analysis of the pathological gait such that the gait
      deviations and energy consuming mechanisms can be identified and remedial means can be
      implemented.

      The investigators hypotheses will include that there would exist an energy saving mechanism
      of human reciprocating locomotion based on the principle of conservation of mechanical
      energy.Secondly, kinematic and kinetic gait determinants could be derived from the energy
      saving mechanism. Finally, the control of knee joint coordinating with the hip joint
      movements would facilitate the gait progression and further reduce the energy consumption.

      The objective of this clinical trial is to evaluate the gait of paraplegic patients with
      reciprocating gait orthoses and to support the investigators research in biomechanical
      analysis, design and control of reciprocating gait orthoses for paraplegia patients. An
      experiment to study the pathological gait of paraplegia patients with an existing
      reciprocating gait orthosis will be carried out.
Background: Ambulation is a rehabilitation priority for many paraplegic patients, either for
      the psychological reasons or with the aim to achieve partial or full independence. It also
      provides the therapeutic benefits which are widely acknowledged to improve urinary drainage,
      to improve peripheral circulation, and to prevent the complication caused from bedridden,
      such as contracture, osteoporosis, urinary tract infection, and constipation etc. Some
      studies also found that ambulation will increase cardiopulmonary function. For those
      pediatric spinal cord-injured patients, the upright posture also profits the development of
      trunk and head control. There are a number of reciprocating gait orthoses (RGOs) available in
      practice for paraplegics, the problems of which have been slow, heavy and high
      energy-consumption. The biomechanical causes are not fully understood. Despite all the
      benefits that RGOs can offer, research and clinical experience indicated that most paraplegia
      patients choose wheelchair mobility after discharge to the community because it is faster,
      safer and needs less energy expenditure. Therefore, a biomechanical study of the pathological
      gait of paraplegia patients with RGOs is critically needed. The problems of currently applied
      RGOs need to be analyzed and remedial means to be proposed. In addition, a new RGOs system is
      also needed to serve as a research tool and a platform proving the remedial ideas.

      Literature Review: There are many kinds of gait orthoses prescribed for paraplegics, which
      can be grouped according to the patterns of propulsion. The first type is a group of
      swing-through gait orthoses which include the Knee-Ankle-Foot orthoses (KAFO),
      Hip-Knee-Ankle-Foot orthoses (HKAFO), and the parapodium. The swing-through gait has high
      energy cost and users give up the orthoses easily. Swivel walkers belong to the second group,
      which enables paraplegic patients to ambulate in an upright position without the use of
      crutches or other walking aids. Patients progress by shifting the center of gravity; and
      increase the walking speed by swing their arms and by the rotation of the trunk. Loretta et
      al. compared the swivel gait with the swing gait, which shows the swivel gait has slower
      speed but more efficient gait which implies that lower metabolic cost and oxygen consumption
      are needed. Although the swivel walker has the advantages of providing low energy and
      hand-free walking, it was most criticized for its low walking speed and for its inability to
      ambulate on an uneven surface. The third one is a group of reciprocating gait orthoses which
      were developed with a belief that they would provide a more energy efficient gait than other
      gait orthoses. The LSU RGOs developed in the early 1980's has hip joints that are linked to
      act in a reciprocal pattern. In the early 1990s, there were two revised version of the LSU
      RGOs developed, ARGOs (Advanced RGOs using one cable and IRGOs (Isocentric RGOs) using a
      solid rocker bar. The hip guidance orthosis (HGOs) that provides friction-free hip joint also
      allows patients to walk reciprocally. WO, walkabout orthosis, is an infraperineal structure
      that also facilitates reciprocating walking. Comparing with HKAFO, RGOs was heavier, slower,
      and the energy cost (mL/kg/m) was higher although the energy consumption rate (mL/kg/min) was
      significantly higher for children in HKAFOs.

      To achieve an efficient gait and to overcome the problem to be slow, the hybrid system, that
      is the combination of the FES and RGOs , had shown the possibility for improvement. Because
      this system used both the RGOs structural stability and muscle power stimulated by FES to
      decrease the activity of the trunk muscles in prevention from fatigue, it can provide more
      energy-efficient gait that increases the aerobic-anaerobic threshold of the patients in the
      long term.

      Many orthotic options for paraplegia are available but only to provide limited walking
      functions with great energy consumption, which has been the reason for the frequent
      abandonment or the low utilization of the RGOs. To improve the design reducing the energy
      expenditure, it requires biomechanical analysis of the pathological gait such that the gait
      deviations and energy consuming mechanisms can be identified and remedial means can be
      implemented. There has been a recent research on the biomechanical analysis of an ARGOs
      user's gait and some possible mechanisms contributing to the high energy consumption were
      discussed. However, no further remedial action in terms of design parameters was suggested in
      their work. It is obvious that more research on the biomechanical study are needed to advance
      the development of orthotic solutions for paraplegia patients.

      Gait determinants were to identify the sources which affect the energy expenditure. The
      determinants include pelvic rotation, pelvic list, knee flexion at mid-stance, foot and ankle
      motion, knee motion and lateral pelvic displacement. There were studies to evaluate the
      effects of these kinematic gait determinants on reduction of the vertical displacement of the
      Body Center of mass (BCOM). Gard and Childress found that the magnitude of the trunk's
      vertical excursion was virtually unaffected by pelvic list. Kerrigan pointed out the there
      are other primary gait determinants needed to explain the actual reduction in BCOM vertical
      displacement. A reduction of BCOM vertical excursion may have significant energy
      implications, but it requires kinetic consideration to prove the gait determinants do affect
      the energy expenditure.

      Kinetic consideration was given in studies to the analysis of mechanical energy emphasizing
      the exchange between potential and kinetic energy. A study of normal subjects suggested a
      greater exchange between potential and kinetic energy near individually preferred walking
      speeds. Since it was previously found that the self-selected speed minimizes the energy cost,
      it can be readily induced that the normal gait with lower energy cost implies a greater
      conservation of mechanical energy, i.e., a greater exchange between potential and kinetic
      energy. It remains unclear as to what roles the gait determinants play in conserving the
      mechanical energy.

      In addition, joint biomechanics in the dynamic coordination particularly could never be
      overemphasized when the energy consumption during ambulation is concerned. Gait efficiency in
      terms of energy cost for ankle fusion patients reached 90% but the hip fusion patients
      achieved only a 53% gait efficiency. The ankle fusion does not require major compensatory
      movements in the gait pattern but only local substitutions in mid and forefoot areas were
      observed. When the hip and the knee were disturbed, patients require pay in energy
      consumption and compensatory substitutions for the lost function in the hip and the knee. It
      implies that coordination of the knee and the hip has higher priority than the ankle and
      human coordinating knee and hip movements could negotiate fairly well even with ankle
      disturbance in walking to maintain energy consumption and speeds.

      A hybrid orthosis system (HOS) has been being studied for walking after spinal-cord injury
      (SCI), which coordinates the mechanical locking and unlocking of knee and ankle joints of a
      reciprocating gait orthoses, while propulsive forces are injected and unlocked joints
      controlled with functional neuromuscular stimulation. A feasibility study was carried out for
      a functional neuromuscular stimulation powered mechanical gait orthosis with coordinated
      joint locking (stance control KAFO). A laboratory hybrid RGOs was developed using a HKAFO
      which contains controllable friction brakes at both hip and knee joints. A
      computer-controlled orthosis system has been developed to address the problems of rapid
      muscle fatigue and poor movement control that are characteristic of FES-aided gait. However,
      the theme was not on the hip and knee coordination. In order that the coordination of hip and
      knee joints can be studied, a computer simulation and experiment validation are necessary.
      Therefore, a research tool needs to be developed so that a study can be conducted on the
      effectiveness of the knee and hip coordination on the reduction of energy expenditure during
      ambulation in paraplegia patients with reciprocating gait orthoses.

      Research Objectives: In this research, the investigators hypotheses will include that there
      would exist an energy saving mechanism of human reciprocating locomotion based on the
      principle of conservation of mechanical energy.Secondly, kinematic and kinetic gait
      determinants could be derived from the energy saving mechanism. Finally, the control of knee
      joint coordinating with the hip joint movements would facilitate the gait progression and
      further reduce the energy consumption.

      Experimental equipments, devices and protocols: The patient evaluation, RGOs design and
      fabrication, and fitting will be done under supervision of qualified orthotists in the
      Rehabilitation Engineering Research Center at National Taiwan University (NTURERC). A Cosmed
      K4b2 portable gas analysis system will be used to acquire physiological measures such as
      heart rates and oxygen consumption. A three dimensional motion measurement system (Optotrak®
      Certus™, Northern Digital Inc., Waterloo, Ontario, Canada) with two position sensors, each
      with three cameras, will be used to collect kinematic data. Twelve rigid bodies with active
      markers will be attached on the segments of subjects of the left upper arms, thighs, shanks,
      heels, and the pelvis and the trunk. Eight force plates (AMTI) will be used to calculate the
      kinetics of the segments of the lower limbs when using assistance. Participants will be given
      instructions for the experiment. Patient's medical data such as diagnosis, onset, birth date,
      gender, height and weight will be taken and basic data of normal subjects' will be collected
      as well. Paraplegic subjects will walk at their self selected speeds and complete at least
      three trials. The kinematic and kinetic data will be collected synchronously. Patients will
      be asked to walk at their self selected speed for 30 meters along a designated route three
      times in order to measure heart rates and oxygen consumption.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: the difference of joint kinetic data in able-bodied subjects and RGO users
time frame: baseline, 30 minutes after fitting of the RGOs
description: joint force, joint moment and joint power during gait
measure: the difference of gait parameter in able-bodied subjects and RGO users
time frame: baseline, 30 minutes after fitting of the RGOs
description: stride length, gait cycle period, gait speed
measure: the difference of joint kinematic data in able-bodies subjects and RGO users
time frame: baseline, 30 minutes after fitting of the RGOs
description: joint angle, joint excursion, joint angular velocity and acceleration
measure: the difference of energy flow in able-bodied subjects and RGO users
time frame: baseline, 30 minutes after fitting of the RGOs
description: measurement of the joint and segmental mechanical energy transfer during gait while using orthoses
arm group label: Energy expenditure, gait pattern, RGOs
arm group type: Experimental
description: using motion capture system and forceplates to monitor gait pattern while wearing reciprocating gait orthoses to calculate the mechanical energy cost
intervention type: Device
intervention name: RGOs(reciprocating gait orthoses)
description: using additional apparatus combined with Hip-Knee-Ankle-Foot orthoses (HKAFO) to help paraplegia patients to present reciprocating gait pattern
arm group label: Energy expenditure, gait pattern, RGOs
other name: other name:HKAFO(Hip-Knee-Ankle-Foot orthoses)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Liang-Wey Chang, Ph.D.
role: Principal Investigator
affiliation: Rehabilitation Engineering Lab,NTU
last name: Liang-Wey Chang, Ph.D
phone: +886-2-3366-3298
email: bmechlw@ntu.edu.tw
last name: Sheng-Ming Huang, Master
phone: +886-2-3365-3368
phone ext: 101
email: odrow.lin@msa.hinet.net
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Taiwan
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
mesh term: Muscular Atrophy
mesh term: Muscular Atrophy, Spinal
mesh term: Paraplegia
mesh term: Meningomyelocele
mesh term: Spina Bifida Cystica