Effects of Intensive Robot-assisted Therapy in Patients With Subacute Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Robot-assisted training (RT) devices developed to date have a significant impact on stroke
      rehabilitation. Several research groups have developed the robotic devices and examined their
      efficacy on improving upper limb function after stroke. All these robotic devices have been
      applied in stroke rehabilitation and their efficacy are evaluated, but the scientific
      evidence for the mechanisms of RT-induced recovery, the optimal treatment intensity, and the
      impact on physiological responses is still lacking.

      This trial is to examine (1) the immediate effects of treatment intensity in RT on
      sensorimotor impairments and functional performance in patients with subacute stroke; (2) the
      long-term benefits of treatment intensity in RT by conducting a 6-month follow up evaluation;
      and (3) the effects of RT on cortical/movement reorganization as well as on the physiological
      markers of inflammation, oxidative stress, and erythrocyte deformability. These overall
      findings will help better understanding of the efficacy of RT on functional outcomes, brain
      and movement reorganization, and physiological markers.
    

Detailed description: 
      Subacute stroke participants will be recruited from the Chang Gung Memorial Hospital and then
      were randomly assigned to 1 of the 3 groups: RT with higher-intensity group, RT with
      lower-intensity group, and conventional intervention group. Assessments on sensorimotor
      impairments (Fugl Mayer Assessment, Motor Status Scale, Modified Ashworth Scale, Myoton,
      Muscle Metabolism, Box and Block Test, and Revised Nottingham Sensory assessment) and
      functional performance (Functional Independence Measure, Motor Activity Log, ABILHAND
      Questionnaire, Adelaide Activities Profile, EQ-5D-5L, and accelerometer) take about 40
      minutes to complete. Evaluation of brain reorganization using functional magnetic resonance
      image and movement patterns by kinematic analysis take about 1 hour for each examination.
      Blood samples of the patients (12 ml.) will be collected to examine the physiological markers
      (ie, inflammation-related markers, oxidative stress markers, and erythrocyte deformability)
      before and after intervention. Total 24 ml blood will be collected in this study. Except for
      the blood taking, all the examinations are non-invasive.
    

Intervention name(s): RT; Conventional rehabilitation (CR)
Intervention type(s): Device; Behavioral
Intervention description(s): The Bi-Manu-Track enables the symmetrical practice of 2 movement patterns in conjunction with computer games: forearm pronation-supination and wrist flexion-extension. Each movement has three computer-controlled modes: (1) passive-passive, with both arms being moved by the machine with speed and range of motion individually adjustable; (2) active-passive, with the nonaffected arm driving the affected arm in a mirror-like fashion; and (3) active-active, with both arms actively moving against resistance. The speed of movement, the amount of resistance, and the range of movement can be adjusted individually. The device has a mechanical breaking of the movement when the torques exceeded 4 Nm, emergency breaks in the reach of the patients, skin friendly materials, and minimal risk for contusions.; CR will focus on neurodevelopmental techniques with emphasis on functional tasks when possible. The functional training will be designed based on patients' motor capacity and include gross motor and fine motor dexterity training, and transitive and intransitive training. Stretching of the more affected limb, passive and active range of movements, and normalizing muscle tone by applying reflex inhibition patterns, inhibiting abnormal patterns, weight bearing with the affected limb will be applied to assist in functional task practice.
Other intervention name(s): Bi-Manu-Track; Reha-Stim Co., Berlin, Germany; CR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intensive Robot Assisted Therapy; Subacute Stroke; Brain Reorganization; Sensory Motor; Physiological Marker