Comparative Efficacy Research of Robot-Assisted Therapy With and Without Constraint-Induced Therapy in Stroke Rehabilitation
Condition: Cerebrovascular Accident
MeSH terms: Stroke
Study type: Interventional

Summary: 
      There are 3 specific study purposes. First, we will examine the treatment effects of RT
      combined with dCIT (RT + dCIT) compared to RT, dCIT, and a dose-matched control therapy
      (DMCT) in stroke patients. Outcome domains will include motor, sensory, and muscle functions,
      amount of arm activity in real-life situations, patient-reported outcomes of daily
      performance and quality of life, and kinematic performance. Additionally, potential adverse
      effects including fatigue, pain, and a biomarker of oxidative stress will be examined.
      Second, we will investigate if the demographical and clinical characteristics of stroke
      patients may predict the probability of achieving clinically important changes of treatment
      outcomes. Thirdly, this study will examine whether the improvements after treatment reach
      clinically important or not and assess clinimetric properties of the outcome measures.
    

Detailed description: 
      This research project will investigate the efficacy of RT in sequential combination with dCIT
      relative to the therapies given alone and study the factors relevant to outcomes prediction
      to inform clinical practice. There will be 3 primary purposes in this comprehensive research:

      Ⅰ. We will examine the effects of RT combined with dCIT (RT + dCIT) compared to RT, dCIT, and
      a dose-matched control therapy (DMCT) in stroke patients. Outcome domains will include motor,
      sensory, and muscle functions, amount of arm activity in real-life situations,
      patient-reported outcomes of daily performance and quality of life, and kinematic performance
      at before treatment, midterm assessment, and after treatment. In addition, potential adverse
      effects including post-exertional fatigue, post-exertional pain, and a biomarker of oxidative
      stress will be examined. We hypothesized that the therapeutic regimen combining RT with dCIT
      will contribute to more significantly reduction in impairment and disability for stroke
      patients than the other intervention groups.

      Ⅱ. We will investigate if the demographical and clinical characteristics of stroke patients
      may significantly predict the probability of achieving clinically significant changes of
      treatment outcomes. The proposed candidate predictors will be chronicity, side of lesion,
      muscle tone, finger extension, motor function of distal upper limb (UL), and amount of
      real-life arm activity.

      Ⅲ. We will examine whether the improvements after treatments are clinically important and
      will assess clinimetric properties of the outcome measures to establish the clinical
      significance relevant for individualized stroke rehabilitation. We will also assess and
      compare the clinimetric properties (e.g., validity, responsiveness, minimal detectable
      change, and minimal clinically important difference) of the rehabilitation outcomes to inform
      selection of instruments.
    

Intervention name(s): Robot-assisted therapy; Distributed constraint-induced therapy; Dose-matched control therapy
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Instrumentation of the ArmeoSpring with position sensors at each joint enables it to be used as a 3D input device for computer game play with the hemiparetic arm. Games were designed to simulate functional arm movements to provide training in a simple virtual reality environment. Vu Therapy games were developed with the goal of enabling repetitive task-specific practice including grocery shopping, cleaning a stovetop, and playing basketball. In this way, stroke patients who are unable to use their severely weakened arms in a functional way are able to practice task-specific movements in a simulated, gravity-reduced environment. Auditory and visual feedback is provided throughout game play to maintain the patient's attention and motivation. In addition, users are provided objective feedback of task performance at the end of each game to enhance motivation and awareness of progress.; The dCIT group will focus on restriction on movement of the unaffected hand by placement of the hand in a mitt for 6 hours/day and intensive training of the affected UL in functional tasks for 1.5 hours/weekday over the 4 weeks. Participants in this group will focus on the intensive training of the affected arm in functional activities with behavioral shaping. The shaping techniques will involve individualized task selection, graded task difficulty (e.g., practicing deficient parts of the selected activity and then performing the entire activity), verbal feedback, prompting, physical assistance with movements, and modeling. The level of challenge will be adapted based on patient ability and improvement. Participants will be also required to place their unaffected hand and wrist in a mitt for 6 hours a day during the 4-week period and document mitt compliance in daily logs.; The DMCT group mediated by the therapists will be designed to control for the duration of therapy in amount of therapy hours. This group will received a structured protocol using conventional occupational therapy techniques such as neuro-developmental techniques with emphasis on functional tasks and muscle strengthening. The treatment protocol will include (1) passive range of motion exercises, stretching of the affected limb, or facilitatory and inhibitory techniques for 15 to 20 minutes, (2) tasks for training fine motor or dexterous function for 20 minutes, (3) arm exercises or gross motor training for 20 minutes, (4) muscle strengthening of the affected UL for 15 to 20 minutes, and (5) activities of daily living or functional tasks practice for 15 to 20 minutes. The activities will be adapted based on the level of motor impairment and individual needs of the patients.
Other intervention name(s): RT; dCIT; DMCT
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: comparative efficacy research; combination therapy; neurorehabilitation; robot-assisted therapy; constraint-induced therapy