Arm Robotics in Musculoskeletal Rehabilitation
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      This purpose of this study is to determine the outcomes of the first-known application of
      robotic therapy in the rehabilitation following rotator cuff repair, using a novel vertical
      oblique robotic module.
    

Detailed description: 
      Musculoskeletal conditions are a leading cause of disability in the United States accounting
      for more than 130 million patient visits to healthcare providers annually. Rotator cuff tears
      are one of the most common causes of pain and disability of the upper extremity. Impaired
      motor control of the shoulder girdle muscles with concomitant instability often exists prior
      to any surgical procedure. Re-tears and/or attenuation after rotator cuff repairs occur
      relatively frequently and may compromise the functional result. Loading of the UE during
      rehabilitation, thus the repair site, following the surgical procedure has been implicated in
      these complications Conventional shoulder rehabilitation protocols with the human-human
      interface do not possess the ability to systematically quantify dosing and progression for
      patients in the subacute stages thus, potentially overloading the repair site. No
      evidence-based research exists comparing outcomes of specific rehabilitative training
      protocols in these post-surgical patients. Consensus statements conclude, �a need for
      clinical trials, and validated outcome measures is essential�.

      Advances in robotics technology offer unprecedented opportunities to improve rehabilitation
      pathways, but until now these technologies have focused primarily on neurological disease.
      The MIT Newman Laboratory for Biomechanics and Human Rehabilitation upper extremity (UE)
      robot is an impedance controlled, back-drivable, oblique-vertical vertical robot that has
      been designed such that it can safely exert controlled, graded forces to move or guide a
      limb, functioning in passive, active-assistive, active and resistive modes, providing
      objective data on the motion. A major advantage is its capacity for real-time, graded changes
      based on patient input, providing stability against random perturbations, increasing or
      withdrawing assistance and allowing for dose-specific treatment. The vertical robot device
      has been shown to be safe and well tolerated without any adverse effects such as shoulder
      pain.

      Goal-directed, quantifiable rehabilitation protocols for redevelopment of function through
      improved range of motion, strength and motor control are lacking in patients with
      musculoskeletal impairments. The successful robotic-assisted rehabilitation of the acute and
      chronic, severe impairment provides an impetus for applying this technology to UE
      musculoskeletal impairments. The ability to objectively control and measure the dosing and
      progression during the rehabilitation process is a valuable tool in the advancement of
      evidence�based rehabilitation interventions The proposed pilot clinical trial will determine
      if 8-weeks of robotic rehabilitation improves the rate and quality of recovery of range of
      motion, strength, and function following rotator cuff repair compared with a conventional
      physical therapy rehabilitation protocol.
    

Intervention name(s): Robotic Therapy
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cuff, rotator; Rotator cuff