Effects of Unilateral Robotic Assistance on Compensation Strategies and Muscular Activity During Hemiparetic Gait
Condition: Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)
MeSH terms: Paralysis; Hemiplegia; Paresis
Study type: Interventional

Summary: 
      Hemiparetic gait is characterized by strong asymmetries that could severely affect the
      quality of life of stroke survivors. This asymmetry is due to motor deficits in the paretic
      leg and the resulting compensations in the non-paretic limb.

      In this study, the investigators aim to evaluate the effect of actively promoting gait
      symmetry in hemiparetic patients by assessing the motion and muscular activity of both
      paretic and non-paretic lower limbs. To this end, the investigators use a unilateral active
      Knee-Ankle-Foot Orthosis able to assist the paretic limb of hemiparetic patients during gait.

      The system is able to synchronize its action with the movement of the unassisted joints,
      promoting a natural and intuitive interaction. The device generates assistance to induce a
      healthy gait pattern on the paretic leg.

      The hypothesis is that a proper and natural interaction between the user and the exoskeleton
      would enable the patients to consider the robot action as a part of their own gait
      capability, improving their gait quality as consequence. Hemiparetic asymmetry is not only
      due to impairments in the affected limb, but also it is the consequence of biomechanical
      compensatory mechanisms that might arose in the non-paretic leg. The aim of this study is to
      assess the adaptation process of the subject to the exoskeleton assistance, and to evaluate
      the effects of such human-robot interaction in both paretic and non-paretic legs.
    

Detailed description: 
      - Materials: The investigators have developed a Knee-Ankle-Foot orthosis (KAFO) composed of
      two joints aligned to the knee and ankle of the user. The length of its bars and the
      positions of its braces can be tailored to the anthropometry of different users. The knee
      joint is actuated by a DC brushless motor EC-60 flat 408057 (Maxon ag, Switzerland) coupled
      with a harmonic drive CSD-20-160-2AGR (Harmonic Drive LLC, EE.UU.). The transmission ratio of
      1:60 of this system enables the application of a mean torque of 35Nm. The ankle joint of the
      prototype remains non-actuated and unlimited, enabling its free movement in the sagittal
      plane. The total weight of the KAFO is about 4kg.

      The prototype is equipped with sensors that provide information on system variables that are
      used for its control in real-time, such as the flexion angle of the robot joint or the
      interaction torque between user and robot. In addition, the gait kinematic of the user is
      measured by Inertial Measurement Units (IMUs) and the contact of both feet with the floor by
      Force Sensing Resistors (FSRs).

      The system uses an Adaptive Frequency Oscillator to estimate the continuous gait phase of the
      contralateral limb and synchronically assists the paretic leg by inducing a healthy gait
      pattern. The action of the robot depends on the gait phase of the assisted leg: during the
      stance phase, the robot reinforces the limb so the system composed of the leg and the
      exoskeleton can load the user's weight and not collapse, while during the swing phase the
      robot guides the limb's movement according to the Assisted-As-Needed (AAN) paradigm creating
      a force tunnel around the prescribed trajectory.

      - Procedures:

      The experimental protocol is divided in three sessions. During all of them, the patient will
      walk on a treadmill commanded by the physiotherapist while wearing a safety harness to avoid
      falls and while wearing the robotic exoskeleton in the paretic leg. During the second and
      third sessions, electromyography will also be acquired by using surface electrodes (Trigno
      System, Delsys Inc.) and according to the SENIAM guidelines. The muscle activity of Rectus
      Femoris, Biceps Femoris Long Head, Tibialis Anterior and Medial Gastrocnemius of both legs
      will be measured through this method. Each experimental session is described next:

        1. - Training session: The patient will wear the robotic exoskeleton to familiarize with
           the action of the device. Comfortable and maximum velocities will be identified for each
           subject.

        2. - Ramp Velocity Session: the session will be divided into five trials: (a) Pre, the
           patient will not wear the device; (b) Free, the patient will wear the robot but it is
           mechanically decoupled so it will enable the free knee movement; (c) Active, the robot
           will assist the gait until 75% maximum gait velocity ; (d) MaxActive, the robot will
           assist the gait until maximum gait velocity ; and (e) Post, the patient will repeat the
           Pre condition. Velocity will increase from a comfortable velocity to the maximum and
           then come back to the comfortable one.

        3. - Random Velocity session: the session will be divided into the same trials than the
           Ramp Velocity Session.

      The difference between RampVel and RandomVel sessions will be the sequence of gait speeds at
      which the patient will walk. During RampVel, five velocity steps will be defined from
      comfortable to maximum velocity with or without exo (depending on the trial) and coming back
      to comfortable velocity. During RandomVel, the same range of velocity will be used, but
      defining five steps in the whole range and setting them in a random order. In both sessions,
      each gait speed step will last one minute, therefore, all trials will last five minutes.
      Trials Free, Active and MaxActive will be also randomly ordered in each session.

      Between trials, patients will rest during 10 minutes to avoid summation effects. Each session
      will occur in different days, leaving 1 or 2 days in between.

      - Intervention providers A physiotherapist and an engineer will be present during the trials.
      The first will be responsible of assessing the basal gait of the subjects and evaluating
      his/her state while the assistance is provided. The engineer will be responsible of managing
      the device and recording the data.

      Both researchers monitor fidelity to the intervention by direct supervision.

        -  Modes of delivery The protocol is provided to one participant at a time. Each patient
           completes the protocol once.

        -  Location Hospital Beata María Ana (Madrid, Spain)

        -  Tailoring and modifications The protocol remains unaltered across applications. The only
           adaptation to patients is the choice of the comfortable and maximum gait speeds for the
           trials.
    

Intervention name(s): Exoskeleton assisted gait on a treadmill
Intervention type(s): Device
Intervention description(s): The experimental protocol is divided in three sessions. During all of them, the patient will walk on a treadmill for 6 minutes while wearing a safety harness and the robotic exoskeleton in the paretic leg.
- Training session: The patient will wear the robotic exoskeleton to familiarize with the action of the device.
- Ramp Velocity Session: the session will be divided into five trials: (a) Pre, the patient will not wear the device; (b) Free, the patient will wear the robot but it is mechanically decoupled so it will enable the free knee movement; (c) Active, the robot will assist the gait until 75% maximum gait velocity ; (d) MaxActive, the robot will assist the gait until maximum gait velocity ; and (e) Post, the patient will repeat the Pre condition. Velocity will increase from comfortable velocity to the maximum and then come back to the comfortable one.
- Random Velocity session: the session will be divided into the same trials than the Ramp Velocity Session.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hemiparetic Gait; Robotic Knee Exoskeleton