Pilot Study - Comparison of Upper Body Ergometer Vs. Robot in Upper Extremity Motor Recovery Post-Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      We will test whether robot driven, goal directed, trajectory corrected exercise enhances
      motor outcome in the upper limb of stroke patients better than matched motor activity on an
      upper body ergometer (monark).
    

Detailed description: 
      Upper extremity (UE) weakness post-stroke occurs in 70-80% of patients. By 3 months this
      complaint persists in 40% of patients, and by 6 months this complaint persists in a similar
      percentage of patients (1). Greater improvement in motor functional recovery was achieved in
      patients with intact sensation. Shoulder pain persisted in 20% of patients (2). Most of the
      arm recovery occurs in the initial 3 months post-stroke (2,3,4). The Copenhagen stroke study
      found 79% of patients with mild UE paresis achieving functional motor recovery compared to
      18% of patients with severe UE paresis (4). Katrak P et al. found early shoulder shrug and
      synergistic hand movements to be useful bedside predictors of functional motor recovery of
      the UE (5). The initial grade of paresis (measured on admission in the hospital) is the most
      important predictor of motor recovery after stroke, with initial paralysis implying the worst
      prognosis for subsequent motor recovery (6). Perceptual inattention does impact upon UE
      action and functional recovery (7). The UE weakness and functional motor recovery lags behind
      lower extremity (LE) weakness and functional motor recovery because of the complexity of
      motor skills needed for daily living tasks.

      Due to the persistence of upper extremity weakness, different rehabilitation techniques such
      as Constraint Induced (CI) (8,9,10) and robotic (11,12,13) therapies were developed to help
      with meaningful functional motor recovery in the paretic arm (unilateral arm training). Both
      of these forced-use interventions focus on the paretic arm only. The main drawback of the CI
      therapy is that subjects need to have some degree of voluntary movement both at the wrist and
      the digits. Bilateral arm training with rhythmic clueing (BATRAC) has been used in chronic
      stroke patients and has been found to improve functional motor performance in the paretic UE
      (14). The authors in a recent paper showed BATRAC inducing reorganization in contraleisonal
      motor networks based on functional MRI (15). Facilitation of paretic arm movement by the
      non-paretic arm (bimanual movement) is thought to be superior to individual paretic arm
      movement, which indicates both arms to be a coordinated brain unit (16). Richards L et al.,
      in their review article (17) and Vander Lee J et al., in their meta-analysis of randomized
      stroke trials (18) on therapeutic interventions to improve UE function, found extensive
      practice to be the most important factor irrespective of the type of intervention instituted.
      Early repetitive sensorimotor stimulation of the arm results in long-lasting functional motor
      recovery (19).

      The overall goal of this study is to determine whether bilateral arm training with upper body
      ergometer is as or more effective in upper extremity functional recovery than unilateral arm
      training with robot in patients with a recent ischemic and hemorrhagic stroke.
    

Intervention name(s): Robot; Ergometer
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke.Robot.Ergometer.Group OT