Robot-assisted Rehabilitation of Ankle Fractures: Efficacy and Comparison With Traditional Methods
Condition: Ankle Fractures
MeSH terms: Ankle Fractures
Study type: Interventional

Summary: 
      The purpose of this trial is to determine the effectiveness, safety and tolerability of
      robot-assisted rehabilitation using ARBOT in patients with ankle dysfunction resulting from
      work related ankle fractures, compared with conventional rehabilitation programs.
    

Detailed description: 
      INTRODUCTION:

      Robotic devices for lower-limb rehabilitation have been mainly tested in neurologically
      injured patients. Up to now, clinical studies using robotic training in orthopedic conditions
      are few. A pilot study was carried out at INAIL Physical Rehabilitation Center of Volterra
      using ARBOT, a prototypal robotic system for ankle rehabilitation. This device has been
      developed by IIT - Italian Institute of Technology and it consists of a two-degree-of-freedom
      electromechanical platform which is able to perform most of the exercises foreseen by the
      standard rehabilitation programs. By virtue of its innovative motion system and control
      architecture, ARBOT integrates multiple rehabilitation equipment functions, performing also
      special exercise programs such as elastic and fluid-dynamic resistance.

      ARBOT allows training according to programmed sequences, in order to promote range of
      movement, muscular function and proprioceptive recovery. Exercises can be performed with or
      without bearing weight. Moreover, ARBOT is a powerful evaluation instrument for
      physiotherapists in order to verify and record the results of rehabilitative intervention.

      The primary aim of this trial was to determine the effectiveness, safety and tolerability of
      robot-assisted rehabilitation using ARBOT in patients with ankle dysfunction resulting from
      work related ankle fractures, compared with conventional rehabilitation programs. Secondary
      objectives was to investigate correlations among physical and disability parameters, to
      collect data in order to define further study protocols and improve ARBOT's performance and
      ergonomics, and ultimately to evaluate patient satisfaction with respect to robot assisted
      rehabilitation programs.

      METHODS:

      Thirty-two patients with work related injuries resulting in ankle and/or hindfoot fractures
      and subsequent to the immobilization phase was enrolled in an open randomized controlled
      trial over a 30 month period. Each participant was randomly allocated to experimental or
      control group and received a 4-week rehabilitation program (20 sessions, for 5 days/week from
      admission to discharge in the Rehabilitation Centre) and weekly robotic and clinical
      assessments.

      Subjects in the experimental group were treated using ARBOT with passive, active and active
      assisted range-of-motion exercises, resistive exercises in isometric, isotonic, isokinetic,
      elastic and fluid-dynamic conditions, and proprioceptive training. Control subjects were
      assisted by a physiotherapist during range of motion recovery exercises and performed
      resistive and proprioceptive training using Biodex System 3 dynamometer and ProKin PK254
      mobile electronic platform.

      The assessment sessions included measurements of dorsiflexion ROM, isometric and isokinetic
      plantar-flexion torque and proprioceptive performance with ARBOT and 2 minutes walking and
      timed stair climbing test, LEFS-Lower Extremity Functional Scale and AOFAS-Ankle-Hindfoot
      Scale.

      Site monitoring of the study has been conducted according to the standard ISO 14155.
    

Intervention name(s): Specific ankle rehabilitation by ARBOT device; General Rehabilitation; Specific ankle rehabilitation performed by physiotherapist; Specific ankle rehabilitation by Biodex System 3 dynamometer; Specific ankle rehabilitation by ProKin PK254 platform
Intervention type(s): Device; Other; Other; Device; Device
Intervention description(s): ARBOT is a programmable robotic device consisting in a two-degree-of-freedom electromechanical platform developed by Italian Institute of Technology - Advanced Robotics and Rehab Technologies. It is composed of a fixed base, a central strut, a moving platform supporting patient's foot and three actuated limbs with a universal-prismatic-spherical kinematic chain. A six-axis force/torque sensor mounted between the moving platform and the footplate senses the human-robot interaction force and torque. The device is interfaced to a standard all-in-one touch screen Personal Computer with graphic applications to give patients visual feedback in real time.; All patients underwent general rehabilitation (gait training, aerobic conditioning), including - if necessary - an initial weight training phase before the functional full weight-bearing program.; Subjects in the control group underwent manually assisted range of motion exercises.; Subjects in the control group performed non-robotic resistive training using a Biodex System 3 dynamometer; Subjects in the control group performed non-robotic proprioceptive training using a ProKin PK254 mobile electronic platform.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rehabilitation; Robotics