Robotic Rehabilitation and Cognitive Functions
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      A recent multicenter study of the Fondazione Don Gnocchi (FDG) Robotic Rehabilitation Group
      (NCT02879279) showed the efficacy of robotic rehabilitation in upper limb motor recovery
      after stroke using a set of robots and sensor-based devices. In clinical practice, beside
      sensory-motor deficits, stroke patients often present concomitant cognitive impairments (as
      attention and memory disorders). The robotic and technological systems used in the
      above-mentioned study allow training on some cognitive functions such as visual memory,
      visual-spatial functions and working memory, as well as motor training of the upper limb. The
      aim of the study is to assess whether cognitive functions, such as visual memory,
      visual-spatial skills and working memory (evaluated with specific tests) improve after
      robotic therapy of the upper limb in subacute stroke patients.
    

Detailed description: 
      It is estimated that up to three quarters of acute and subacute stroke survivors exhibit
      cognitive impairment. Cognitive impairment can significantly compromise functional recovery,
      quality of life, and social engagement after stroke. Indeed, some authors showed that the
      impairment of cognitive functions can negatively influence rehabilitation strategies. Robotic
      therapy has been proposed as a viable approach for the rehabilitation of the upper limb, as a
      way to increase the amount and intensity of the therapy, and to standardize the treatment,
      adding a complex but controlled multisensory stimulation to the patient. In fact, owing to
      the complex training environments, robotic and technological devices may promote the
      re-learning capacity, inducing functional or structural plasticity in brain networks that
      control both motor and cognitive functions. Our hypothesis is that the cognitive engagement
      of patients during upper limb robotic therapy can impact on some cognitive functions that are
      compromised after the stroke.

      The current pilot study aims to evaluate the effects of an upper limb robotic rehabilitation
      treatment on cognitive functions in patients with subacute stroke.

      Fifty consecutive patients with sub-acute stroke (within 6 months of the event) will be
      enrolled in two rehabilitation centers.

      All patients will perform a robotic treatment of the upper limb (30 sessions, 5 times a week)
      using a set of robotic devices. The training will include motor-cognitive exercises
      specifically selected to train spatial attention, vision and working memory, praxis,
      executive functions, and speed of processing. Furthermore, patients will undergo a
      comprehensive rehabilitation program including individual conventional physiotherapy (6
      times/week), lasting 45 minutes focused on lower limb, sitting and standing training, balance
      and walking.

      Subjects will be evaluated at baseline (T0) and after treatment (T1). To be included in the
      analysis, patients will have to undergo at least 25 rehabilitation sessions, without
      interrupting the treatment (due to clinical complications) for more than six consecutive
      sessions; otherwise, they will be considered as dropouts.

      The effects of the rehabilitation intervention on the upper limb function and disability will
      be assessed with the following clinical scales: Fugl-Meyer Assessment for Upper Extremity
      (FMA), to evaluate motor function; the Motricity Index (MI), to evaluate muscle strength; the
      Modified Barthel Index (mBI), to evaluate activities of daily living (ADL) and mobility.

      Oxford Cognitive Screen (OCS) will be performed as screening tool to evaluate cognitive
      functions. Moreover, the following cognitive tests will be used: 1) Digit Span
      (attention/short-term memory involving strings/series of digits of varying length); 2) Tower
      of London (planning and problem solving); 3) STROOP test (Stroop Color and Word Test); 4)
      Symbol Digit Modalities Test (processing speed of visual stimuli); 5) Rey-Osterrieth Complex
      Figure Test (ROCF) (visuomotor integration).
    

Intervention name(s): Robotic assisted intervention
Intervention type(s): Device
Intervention description(s): Robotic treatment of the upper limb (30 sessions, 5 times a week) using a set of 4 robotic devices: Motore (Humanware); Amadeo, Diego, Pablo (Tyromotion). The training will include motor-cognitive exercises specifically selected to train spatial attention, vision and working memory, praxis, executive function, and speed of processing.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rehabilitation; Robotics; Cognitive Function