Robot-based Wrist Rehabilitation in Orthopaedics: Efficacy and Comparison With Traditional Methods
Condition: Wrist Injuries
MeSH terms: Wrist Injuries
Study type: Interventional

Summary: 
      The present randomized clinical trial addresses the issue about the application of
      robot-based rehabilitation programs in orthopedic conditions. The aim of the study is to test
      the efficacy of a robot-based rehabilitative protocol to recover wrist functionality after
      traumatic injuries.
    

Detailed description: 
      Thirty patients with work related wrist injuries resulting in wrist joint dysfunction are
      enrolled in an open randomized controlled trial over a 24 months period. Each participant is
      randomly allocated to experimental or control group and receives a 3-week rehabilitation
      program including both assessment and rehabilitative sessions. While patients in the control
      group undergo a traditional rehabilitative protocol, the experimental group is treated
      replacing traditional exercises with robot-aided ones performed with WRISTBOT, a 3 Degrees of
      Freedom (DoFs) robotic exoskeleton. WRISTBOT allows for passive, active and assisted
      range-of-motion (ROM) exercises, isotonic and elastic tasks, proprioceptive and perturbation
      training. All subjects perform the same sessions of assessment, which include two evaluations
      through the robotic system and clinical measures at the beginning (Tb) and at the end (Te) of
      the rehabilitative training, and a follow-up through phone call, three months after the end
      of the treatment (Tf). The assessment sessions include a robot-based evaluation (measurement
      of ROM, exerted forces, dexterity, and wrist position sense acuity) and clinical measures
      (Patient Rated Wrist Evaluation, Jebsen-Taylor and Jamar Test). Subjects' level of
      satisfaction about treatment is asked at the end of the rehabilitative treatment (Te). The
      primary objective is to evaluate the results of a robot-based rehabilitative approach on
      wrist functionality after work-related trauma, comparing the effects of robotic therapy with
      those achieved through a conventional therapy.
    

Intervention name(s): Specific wrist rehabilitation by WRISTBOT device; Specific wrist rehabilitation performed by the physiotherapist; General rehabilitation
Intervention type(s): Device; Other; Other
Intervention description(s): The WRISTBOT is a fully backdrivable manipulandum that allows for movements along its 3 Degrees of Freedom (DoFs) in a human-like Range Of Motion (ROM) of the wrist: 62° flexion/extension (FE), -40°/+45° in ulnar/radial deviation (RUD), and 60° pronation/supination (PS). In addition, the robot permits motions along planes that involve combined multi-DoFs movements. Mechanically, the robot was developed to have low values of inertia, emulating the fluency of natural movements. Each DOF is measured by high resolution incremental encoders and actuated by one brushless motor or two in case of the RUD planes, providing both gravity compensation and continuous torque values necessary to manipulate the human wrist joints. Depending on the torques exerted, the device can be used in either active or assistive/passive modality. The system is integrated with a Virtual Reality environment (VR), useful to provide a visual feedback to the user while he/she is requested to complete the tasks.; Passive, active and assisted mobilization; Exercise with elastic bands or weights, exercise of manipulation and dexterity, simulation of daily life activities supervised by the physiotherapist
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study considers participants divided in two groups: the control group and the experimental group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adult; Humans; Middle aged; Robotics / instrumentation*; Wrist Injuries / physiopathology; Wrist Injuries / rehabilitation*