<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/NCT02969772</url>
  </required_header>
  <id_info>
    <org_study_id>06/58891-4</org_study_id>
    <nct_id>NCT02969772</nct_id>
  </id_info>
  <brief_title>Reach and Palmar Grasp in Tetraplegics With Neuromuscular Electrical Stimulation: Assessment and Training.</brief_title>
  <official_title>Reach and Palmar Grasp in Tetraplegics With Neuromuscular Electrical Stimulation: Assessment and Training.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Enio Walker Azevedo Cacho</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Campinas, Brazil</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study was to evaluate the tetraplegics movement strategies, assisted by&#xD;
      Neuromuscular Electrical Stimulation (NMES), on the reach and palmar (RP) grasp to different&#xD;
      weights objects.Tetraplegics had their RP grasp movement captured by four infrared cameras&#xD;
      and 6-reflexive markers attached on the trunk and right arm, assisted or not by NMES, in the&#xD;
      triceps, extensor carpi radialis longus, extensor digitorum communis, flexor digitorum&#xD;
      superficialis, opponens pollicis and lumbricalis muscles. The grasp was made in three&#xD;
      cylindrical objects (different diameters and weights) placed in trunk midline in an&#xD;
      equivalent distance of the arm's length. The patients were able to reach and made palmar&#xD;
      grasp in all cylinders using the stimulation sequences assisted by NMES.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prior to the kinematic captures, all patients selected in the study received 20 sessions of&#xD;
      NMES therapy, twice a week, with 10 weeks of duration. The strengthening sessions plus&#xD;
      training prior to the kinematic study of movement strategies has the objective to condition&#xD;
      the paretic muscles to the functional activity.&#xD;
&#xD;
      Twenty sessions was divided in 10 sessions of strengthening and 10 sessions of the functional&#xD;
      training of reaching and grasping assisted with electrical stimulation.&#xD;
&#xD;
      The strengthening sessions consisted of 20 minutes of electrical stimulation on triceps,&#xD;
      extensor carpi radialis longus, extensor digitorum communis, lumbricalis, flexor digitorum&#xD;
      superficialis and opponens pollicis muscles.&#xD;
&#xD;
      The functional training sessions was performed through movements the reach and palmar grasp&#xD;
      with NMES of the several cylindrical and conical objects of different weights (30 minutes&#xD;
      sessions). The NMES was used to facilitate movements of reach (triceps muscle), opening&#xD;
      (extensor carpi radialis longus and extensor digitorum communis muscle), positioning&#xD;
      (extensor carpi radialis longus, flexor digitorum superficialis and lumbricalis muscle),&#xD;
      palmar grasp (extensor carpi radialis longus, flexor digitorum superficialis, opponens&#xD;
      pollicis muscle) and releasing (extensor carpi radialis longus and extensor digitorum&#xD;
      communis muscle). Since the temporal organization varied among tetraplegics, some of them&#xD;
      required more time to some stages of the sequence.&#xD;
&#xD;
      For NMES, the eight-channel stimulator, controlled by a microcomputer was used with pulse&#xD;
      frequency, 25 Hz; pulse duration, 300 milliseconds; on/off duration 2/2sec; maximum pulse&#xD;
      width fixed at 250 microampere, and the amplitude individually adjusted to achieve the&#xD;
      excitability threshold for each muscle. The amplitude was adjusted throughout the training,&#xD;
      in order to produce the desired muscle contraction. This parameters was used in all of&#xD;
      therapies and in the kinematic assessment. The stimulation was applied with self-adhesive&#xD;
      surface electrodes taped to the skin.&#xD;
&#xD;
      For kinematic captures, the participants performed reach and grasp with the dominant arm&#xD;
      (right), assisted and not assisted by NMES. The subjects had no restriction for trunk&#xD;
      anterior shifting but for safety reasons were kept seating upright in their own daily use&#xD;
      wheelchair (the one they were more adapted to) and the non-dominant arm (left) was left&#xD;
      resting over the abdomen in an attempt to minimize the influence of the non evaluated member&#xD;
      on postural control.&#xD;
&#xD;
      For the initial position, the dominant arm was held at the side of the trunk, with the elbow&#xD;
      flexed at 90º and the forearm in neutral position on the table. Tetraplegic subjects were&#xD;
      seated in front of a task-table with the cylinder on it. They were instructed to reach and&#xD;
      grasp three different cylinders (object A :200g weight, 115 mm height, 40 mm diameter; object&#xD;
      B: 270g, 115 mm e 50 mm; and object C: 480g, 115 mm e 60 mm), one at a time and bring it to&#xD;
      the initial hand position.&#xD;
&#xD;
      The analysis of kinematic data was performed from the beginning of the movement (starting&#xD;
      position), until the early return of hand position (with or without the cylinder). The&#xD;
      cylinder was positioned in front of the subject sternum, with a distance equal to the arm's&#xD;
      length (from the medial border of axilla to the distal wrist crease).&#xD;
&#xD;
      The subjects were asked to perform five repetitions of each task for all three cylinders, in&#xD;
      a total of 15 repetitions assisted and 15 not assisted by NMES. Once the experiment started,&#xD;
      the subject could not touch the table with the forearm, until the task was finished. The&#xD;
      command used to start the experiment was &quot;GO&quot;, and they were instructed to perform the&#xD;
      movement naturally and not to worry about the velocity and time of duration. Patients were&#xD;
      evaluated in the two situations (with and without NMES) with stimulation electrodes placed in&#xD;
      the skin surface and the cables connected to the stimulator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2005</start_date>
  <completion_date type="Actual">December 2010</completion_date>
  <primary_completion_date type="Actual">December 2006</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Upper limb Kinematics</measure>
    <time_frame>change from baseline at twenty sessions - 5 weeks</time_frame>
    <description>shoulder, elbow and wrist angles; percentage of time to peak velocity; movement time; peak velocity and movement smoothness (number of velocity peaks and index of curvature).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ASIA</measure>
    <time_frame>change from baseline at twenty sessions - 5 weeks</time_frame>
    <description>Classification of injury by American Spinal Injury Association</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SCIM II</measure>
    <time_frame>change from baseline at twenty sessions - 5 weeks</time_frame>
    <description>Spinal cord Independence measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CUE</measure>
    <time_frame>change from baseline at twenty sessions - 5 weeks</time_frame>
    <description>capabilities of upper extremity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FIM</measure>
    <time_frame>change from baseline at twenty sessions - 5 weeks</time_frame>
    <description>Functional independence measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electromyography</measure>
    <time_frame>change from baseline at twenty sessions - 5 weeks</time_frame>
    <description>Clavicular portion of pectoralis major, long head of biceps brachii, anterior and posterior deltoid, triceps and wrist extensors</description>
  </secondary_outcome>
  <other_outcome>
    <measure>demographic dates</measure>
    <time_frame>baseline</time_frame>
    <description>name, address, time since lesion, other injuries.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Tetraplegia</condition>
  <condition>Tetraparesis</condition>
  <arm_group>
    <arm_group_label>Assessment of upper limb variables</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Assessment of clinical variables of tetraplegics reach-and-grasp pattern</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Training protocol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Training with electrical stimulation of upper limb</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assessment of upper limb variables</intervention_name>
    <description>International Standards for Neurological and Functional Classification of Spinal Cord Injuries of American Spinal Injury Association (ASIA); Functional Independence Measure (FIM); The following kinematic variables of arm were studied: shoulder, elbow and wrist angles; percentage of time to peak velocity; movement time; peak velocity and movement smoothness (number of velocity peaks and index of curvature); Capabilities of Upper Extremity instrument (CUE); Spinal cord independence measure (SCIM II); electromyography (Clavicular portion of pectoralis major, long head of biceps brachii, anterior and posterior deltoid, triceps and wrist extensors).</description>
    <arm_group_label>Assessment of upper limb variables</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Training protocol</intervention_name>
    <description>The strengthening sessions consisted of 20 minutes of electrical stimulation on triceps, extensor carpi radialis longus, extensor digitorum communis, lumbricalis, flexor digitorum superficialis and opponens pollicis muscles. The functional training sessions was performed through movements the reach and palmar grasp with NMES of the several cylindrical and conical objects of different weights (30 minutes sessions).</description>
    <arm_group_label>Training protocol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  tetraplegics (C4 to C7), complete or incomplete, traumatic lesion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neurological condition prior to spinal injury, orthopedic conditions in upper limb.&#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>Alberto Cliquet Jr, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Campinas</affiliation>
  </overall_official>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>November 16, 2016</last_update_submitted>
  <last_update_submitted_qc>November 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Campinas, Brazil</investigator_affiliation>
    <investigator_full_name>Enio Walker Azevedo Cacho</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Quadriplegia</mesh_term>
  </condition_browse>
  <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/NCT02969772
org study id: 06/58891-4
nct id: NCT02969772
lead sponsor: 
collaborator: 
has dmc: Yes
The aim of the study was to evaluate the tetraplegics movement strategies, assisted by
      Neuromuscular Electrical Stimulation (NMES), on the reach and palmar (RP) grasp to different
      weights objects.Tetraplegics had their RP grasp movement captured by four infrared cameras
      and 6-reflexive markers attached on the trunk and right arm, assisted or not by NMES, in the
      triceps, extensor carpi radialis longus, extensor digitorum communis, flexor digitorum
      superficialis, opponens pollicis and lumbricalis muscles. The grasp was made in three
      cylindrical objects (different diameters and weights) placed in trunk midline in an
      equivalent distance of the arm's length. The patients were able to reach and made palmar
      grasp in all cylinders using the stimulation sequences assisted by NMES.
Prior to the kinematic captures, all patients selected in the study received 20 sessions of
      NMES therapy, twice a week, with 10 weeks of duration. The strengthening sessions plus
      training prior to the kinematic study of movement strategies has the objective to condition
      the paretic muscles to the functional activity.

      Twenty sessions was divided in 10 sessions of strengthening and 10 sessions of the functional
      training of reaching and grasping assisted with electrical stimulation.

      The strengthening sessions consisted of 20 minutes of electrical stimulation on triceps,
      extensor carpi radialis longus, extensor digitorum communis, lumbricalis, flexor digitorum
      superficialis and opponens pollicis muscles.

      The functional training sessions was performed through movements the reach and palmar grasp
      with NMES of the several cylindrical and conical objects of different weights (30 minutes
      sessions). The NMES was used to facilitate movements of reach (triceps muscle), opening
      (extensor carpi radialis longus and extensor digitorum communis muscle), positioning
      (extensor carpi radialis longus, flexor digitorum superficialis and lumbricalis muscle),
      palmar grasp (extensor carpi radialis longus, flexor digitorum superficialis, opponens
      pollicis muscle) and releasing (extensor carpi radialis longus and extensor digitorum
      communis muscle). Since the temporal organization varied among tetraplegics, some of them
      required more time to some stages of the sequence.

      For NMES, the eight-channel stimulator, controlled by a microcomputer was used with pulse
      frequency, 25 Hz; pulse duration, 300 milliseconds; on/off duration 2/2sec; maximum pulse
      width fixed at 250 microampere, and the amplitude individually adjusted to achieve the
      excitability threshold for each muscle. The amplitude was adjusted throughout the training,
      in order to produce the desired muscle contraction. This parameters was used in all of
      therapies and in the kinematic assessment. The stimulation was applied with self-adhesive
      surface electrodes taped to the skin.

      For kinematic captures, the participants performed reach and grasp with the dominant arm
      (right), assisted and not assisted by NMES. The subjects had no restriction for trunk
      anterior shifting but for safety reasons were kept seating upright in their own daily use
      wheelchair (the one they were more adapted to) and the non-dominant arm (left) was left
      resting over the abdomen in an attempt to minimize the influence of the non evaluated member
      on postural control.

      For the initial position, the dominant arm was held at the side of the trunk, with the elbow
      flexed at 90º and the forearm in neutral position on the table. Tetraplegic subjects were
      seated in front of a task-table with the cylinder on it. They were instructed to reach and
      grasp three different cylinders (object A :200g weight, 115 mm height, 40 mm diameter; object
      B: 270g, 115 mm e 50 mm; and object C: 480g, 115 mm e 60 mm), one at a time and bring it to
      the initial hand position.

      The analysis of kinematic data was performed from the beginning of the movement (starting
      position), until the early return of hand position (with or without the cylinder). The
      cylinder was positioned in front of the subject sternum, with a distance equal to the arm's
      length (from the medial border of axilla to the distal wrist crease).

      The subjects were asked to perform five repetitions of each task for all three cylinders, in
      a total of 15 repetitions assisted and 15 not assisted by NMES. Once the experiment started,
      the subject could not touch the table with the forearm, until the task was finished. The
      command used to start the experiment was "GO", and they were instructed to perform the
      movement naturally and not to worry about the velocity and time of duration. Patients were
      evaluated in the two situations (with and without NMES) with stimulation electrodes placed in
      the skin surface and the cables connected to the stimulator.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Upper limb Kinematics
time frame: change from baseline at twenty sessions - 5 weeks
description: shoulder, elbow and wrist angles; percentage of time to peak velocity; movement time; peak velocity and movement smoothness (number of velocity peaks and index of curvature).
measure: ASIA
time frame: change from baseline at twenty sessions - 5 weeks
description: Classification of injury by American Spinal Injury Association
measure: SCIM II
time frame: change from baseline at twenty sessions - 5 weeks
description: Spinal cord Independence measure
measure: CUE
time frame: change from baseline at twenty sessions - 5 weeks
description: capabilities of upper extremity
measure: FIM
time frame: change from baseline at twenty sessions - 5 weeks
description: Functional independence measure
measure: Electromyography
time frame: change from baseline at twenty sessions - 5 weeks
description: Clavicular portion of pectoralis major, long head of biceps brachii, anterior and posterior deltoid, triceps and wrist extensors
measure: demographic dates
time frame: baseline
description: name, address, time since lesion, other injuries.
arm group label: Assessment of upper limb variables
arm group type: Experimental
description: Assessment of clinical variables of tetraplegics reach-and-grasp pattern
arm group label: Training protocol
arm group type: Experimental
description: Training with electrical stimulation of upper limb
intervention type: Other
intervention name: Assessment of upper limb variables
description: International Standards for Neurological and Functional Classification of Spinal Cord Injuries of American Spinal Injury Association (ASIA); Functional Independence Measure (FIM); The following kinematic variables of arm were studied: shoulder, elbow and wrist angles; percentage of time to peak velocity; movement time; peak velocity and movement smoothness (number of velocity peaks and index of curvature); Capabilities of Upper Extremity instrument (CUE); Spinal cord independence measure (SCIM II); electromyography (Clavicular portion of pectoralis major, long head of biceps brachii, anterior and posterior deltoid, triceps and wrist extensors).
arm group label: Assessment of upper limb variables
intervention type: Other
intervention name: Training protocol
description: The strengthening sessions consisted of 20 minutes of electrical stimulation on triceps, extensor carpi radialis longus, extensor digitorum communis, lumbricalis, flexor digitorum superficialis and opponens pollicis muscles. The functional training sessions was performed through movements the reach and palmar grasp with NMES of the several cylindrical and conical objects of different weights (30 minutes sessions).
arm group label: Training protocol
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Alberto Cliquet Jr, PhD
role: Principal Investigator
affiliation: University of Campinas
responsible party type: Sponsor-Investigator
investigator affiliation: University of Campinas, Brazil
investigator full name: Enio Walker Azevedo Cacho
investigator title: PhD
mesh term: Quadriplegia
sharing ipd: No