Robotic Assisted Upper-Limb Neurorehabilitation in Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Intervention: Robot-Assisted Therapy - MIT-MANUS System; Intensive Comparison Therapy; Usual Care
Intervention description: The MIT-MANUS robot consists of four modules to train the entire upper limb: module A: shoulder-elbow; module B: anti-gravity; module C: wrist, and module D: hand-unit. Training will be given for 12 weeks and is divided into 4 consecutive blocks, with 9 training sessions per block.; The intensive comparison therapy protocol being used in CSP#558 was developed and field-tested at the Burke Rehabilitation Hospital. It exposes the patient to the identical number of treatments, time, and intensity that robot treated patients will receive (12 weeks, 3 times per week). Therapy sessions can be conducted on back-to-back days if needed and on more than 3 days a week (with approval from the Study Chairman) over a treatment period of up to 14 weeks in order to complete the 36 treatment sessions. During each 1-hour session, subjects participate in therapy in four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques (NDT)/Bobath arm training (Bobath, 1979).; The usual chronic stroke care as delivered at each participating medical center
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stroke; Rehabilitation; Single-blind; Clinical Trial; Randomized controlled trial; Upper extremity; Robotics

Summary:

      This study will compare robotic training with usual care and intensive comparison therapy to
      attempt to improve upper extremity function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A single new focal unilateral stroke with diagnosis verified by brain imaging (MRI) or
             CT scan that has occurred at least 6 months prior to enrollment.

          -  Age 18 years of age and older.

          -  Upper extremity Fugl-Meyer score >=7 or <=38 (max 66). (These thresholds include
             neither hemiplegic nor fully recovered motor function in 14 muscles of the shoulder,
             elbow, and wrist.)

          -  Cognitive function sufficient to understand the experiments and follow instructions
             (Mini-Mental Status Score of 22 and higher or interview for aphasic subjects).

          -  Willingness to avoid any new alternative arm rehabilitative approaches for the
             duration of the study.

          -  Written informed consent to participate in the study.

        Exclusion Criteria:

          -  A fixed contracture in the affected limb that prevents movement along the entire
             dynamic range required by either robot-assisted or intensive comparison therapy.

          -  Joint pain that occurs within the range of motion required by the intervention
             protocols (intensive comparison therapy and robot-assisted therapy).

          -  Enrolled in or planning to enroll in another interventional research trial that
             involves the upper limbs using procedures proposed to enhance or limit the function of
             the upper extremity (such as adjuvant rehabilitation or Botox injections) during the
             36 weeks of participation.

          -  Prior experience with robot-assisted therapy or intensive comparison therapy for the
             upper limb as described in this specific study.

          -  A complicating medical condition that would prevent completion of the trial.

          -  Unable to complete the nine-month study, e.g., extended planned vacation.

          -  Any other known pre-existing bone diseases that might increase the risk of bone
             fracture or other injury from intensive comparison therapy or robot-assisted therapy.