Walkbot Robotic Training for Improvement in Gait
Condition: Ischemic Stroke; Gait, Hemiplegic
MeSH terms: Ischemic Stroke; Gait Disorders, Neurologic
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical study will involve up to 30 ischemic stroke inpatients during their stay at
      Burke Rehabilitation Hospital. Participants will be randomized to receive 30 additional
      minutes of therapy every day, for a total of 2 weeks (14 days). One group will receive 30
      minutes of standard physical therapy focused on pre-gait or gait training activities, while
      the experimental group will receive 30 minutes of Walkbot with Augmented Reality. Both groups
      will receive the same time in therapy aimed at gait training.
    

Detailed description: 
      This controlled clinical study will involve 30 ischemic stroke inpatients during their stay
      at Burke Rehabilitation Hospital (typical inpatient arrives 7 days post-stroke and is
      admitted for ~16 days).

      Stroke inpatients will be sequentially randomized into one of two groups within the first
      week after admission. Both Groups will receive 30 additional minutes of therapy every day,
      for a total of 2 weeks (14 days). Group A will enroll 15 patients who will receive usual
      inpatient care including at least one 60-minute session of physical therapy per day, and an
      additional 30-minute session of standard physical therapy focused on pre-gait and/or gait
      training activities 5-days per week during the duration of their stay (14 days). Group B will
      enroll 15 patients who receive usual inpatient care that includes at least one 60-minute
      session of physical therapy and an additional 30-minute session of Walkbot with Augmented
      Reality 5-days per week during the duration of their stay (14 days). Both groups will receive
      the same time in therapy aimed at gait training. The extra therapy group will not exceed more
      than 15 minutes of pregait training before starting to walk the patient, and will spend at
      least 15 minutes doing active gait training per session. Patients in the treatment group will
      receive 30 minutes of total training on the Walkbot, excluding setup time. Primary and
      secondary outcomes will be collected, prior to the first therapy session. Follow up outcome
      measures will be collected within two days after the final interventional (study) therapy
      session. The amount of therapists needed for each session will be logged for every patient
      after Walkbot training or extra physical therapy. Borg rating of perceived exertion will be
      taken after each session from the patients, and NASA Task Load Index will be completed by the
      therapists (ie therapist load). Outcomes will be analyzed for significant differences.
    

Intervention name(s): Walkbot; Physical Therapy
Intervention type(s): Device; Behavioral
Intervention description(s): Walkbot is a Robot Assisted Gait Training System. This system is designed to maximize muscle strength, range of joint motion, and gait function while participants engage in a virtual reality game.; 30-minute session of standard physical therapy focused on pre-gait and/or gait training activities 5-days per week during the duration of their stay (14 days).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sequential randomization into one of two groups within first week after admission.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment