Effects of Robot-Assisted Upper Extremity Training on Cognitive and Physical Functions After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Stroke is a main cause of disability worldwide. It is characterized by motor and cognitive
      impairments leading to activity limitations and participation restrictions. Despite
      improvement in mortality and morbidity following stroke, stroke survivors need access to
      effective rehabilitation services. Management approach for stroke survivors is classical
      physical and rehabilitation medicine (PRM) interventions. Nowadays, with the advancement of
      technology, robotic rehabilitation systems have taken its place among the classical physical
      and rehabilitation medicine applications. Robotic systems for upper and lower extremity help
      to improve neuroplasticity by repetitive task-specific activities. Upper extremity robotic
      systems can be either exoskeleton or end-effector according to their mechanical designs.
      Exoskeleton robotic systems attach to both proximal and distal segments of the upper
      extremity (shoulder, elbow, forearm, wrist, fingers) and provide antigravity weight support
      allowing actuated axes of movements of the upper extremity joints. The system allows the
      reinforcement and facilitation of movements by means of visual feedback with a 3-dimensional
      virtual environment in which the patient is asked to perform various tasks by playing
      computer games. It is reported that robotic therapy can be used complementary to other
      rehabilitation methods. The neurophysiological effects of robotic therapy were shown to act
      in the brain, particularly on the primary motor cortex, putamen and capsula interna. The
      effect on motor recovery was associated with common, synchronous activity involving the
      corticospinal system. It has been reported by a recent Cochrane review that robot-assisted
      arm training improves arm function, arm muscle strength and activities of daily living in
      stroke survivors. A few studies have also reported positive effects on cognitive abilities.
      However, there are no controlled studies in the literature investigating the effects of
      robot-assisted upper limb training on cognitive functions following stroke. The aim of this
      study was to investigate the effects of robot-assisted upper extremity training, applied in
      addition to the classical PRM program, on cognitive and physical functions after stroke.
      Primary aim is to investigate the effects on cognitive functions whereas secondary aim is to
      investigate the effects on upper extremity motor functions and activities of daily living.
      The investigators hypothesized that adjunctive robotic upper extremity training in addition
      to classical PRM program would result in better cognitive and physical outcomes compared with
      the classical PRM program only.
    

Detailed description: 
      This study is planned as a prospective randomized single blind controlled study. It was
      approved by the Ethics Committee of Ankara University, Faculty of Medicine and will be
      conducted in accordance with the Declaration of Helsinki. The study will include 38 stroke
      survivors who are admitted for rehabilitation at the Department of Physical Medicine and
      Rehabilitation, Ankara University Medical Faculty. Patients fulfilling the inclusion criteria
      of the study will randomly be divided into 2 groups as robotic group and control group.
      Random allocation software (RAS) program will be used to assign the patients to the treatment
      groups with "block randomization" method and to create the randomization scheme. In this
      single blinded study, all patients will be evaluated by the same physician (Dr. Merve Dayi).
      The physician will be blind to patient's assignment. Routine physical and rehabilitation
      medicine program including physical therapy and exercises, walking and balance training, and
      occupational therapy to improve activities of daily living will be given to all patients for
      a total of 6 weeks, 5 days/week, 1 hour/day. Robotic group will additionally receive upper
      extremity robotic training therapy with Armeo Spring V2.0 exoskeleton (Hocoma Inc.,Zurich,
      Switzerland) for 6 weeks, 5 days/week, 1 hour/day. The Armeo Spring is an adjustable
      suspension system for the upper limb that connects to virtual reality, which has settings
      with several degrees of complexity. The system is an exoskeleton that supports the patient's
      arm and magnifies any residual active movement of the hemiparetic arm in 3-dimensional space.
      The patients will receive 30 sessions of robotic therapy under the supervision of
      physiotherapists, who will adjust the patient's arm and hand in the device and select the
      virtual reality computer games according to the functional level of the patient's upper limb.
      All individuals participating in the study will be assessed before and immediately after the
      treatment and also 3 months at follow-up. Each assessment will include evaluation of
      cognitive functions, upper extremity motor functions, hand dexterity, upper extremity
      activities and daily living activities.

      Statistical Analysis

      As the primary outcome variable, the difference in cognitive functions measured by the
      Montreal Cognitive Assessment Scale (MoCA) between baseline and post-treatment will be used
      (Δ MoCA). Group sample sizes of 19 and 19 achieve 80% power to detect a Δ MoCA of 2.4 between
      robotic and control groups with estimated group standard deviations of 2.5 and 2.5 and with a
      significance level of 0.05 using a two-sided Mann-Whitney U test. Stratified block
      randomization will be used to ensure an equal number of subjects in each group. Educational
      status and age has been chosen as stratification variables. Difference between two groups for
      continuous variables will be evaluated by Student's t test. Mann-Whitney U test will be used
      to assess difference between two groups in terms of ordinal variables. The differences in
      proportions between groups will be compared by using Chi-Square. The repeated-measures ANOVA
      will be used to test within-group and between-group comparisons for continuous variables and
      interaction between them. p<0.05 will be considered statistically significant.
    

Intervention name(s): Robotic group (Upper extremity robot-assisted training plus routine physical and rehabilitation medicine program); Control group (routine physical and rehabilitation medicine program)
Intervention type(s): Device; Behavioral
Intervention description(s): Upper extremity robot-assisted training will include facilitated shoulder flexion-extension, internal-external rotation, abduction-adduction, elbow flexion-extension, forearm supination-pronation, wrist flexion-extension, ulnar-radial deviation, hand finger flexion-extension movements by means of visual feedback with a 3-dimensional virtual environment in which the patient is asked to perform various tasks such as object reaching, grasping, holding, dropping activities by playing computer games.
Routine physical and rehabilitation medicine program including physical therapy and exercises, walking and balance training, and occupational therapy to improve daily living activities will be given.; Routine physical and rehabilitation medicine program including physical therapy and exercises, walking and balance training, and occupational therapy to improve daily living activities will be given.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomized single blind controlled study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; robotic; upper extremity; rehabilitation