Walkbot Robotic Training for Improvement in Gait

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.

Inclusion Criteria:

- Cortical/subcortical ischemic stroke

- 1st time clinical stroke presentation, or prior stroke with no residual deficits
affecting ambulation

- Ability to follow 2 step commands

- Fugl Meyer Sensory Score > 2

- Suitability for gait training as assessed clinically (ability to ambulate at least one
step with a device/assistance)

- Height 132 cm- 200 cm; hip-knee joint length: 33 cm- 48 cm; knee joint-foot: 33 cm-48
cm

Exclusion Criteria:

- Cerebellar/brainstem stroke

- Body weight >135 kg

- Uncontrolled high blood pressure (stage 2) higher than 160 (systolic)/ 100 (diastolic)

- Cardiopulmonary system impairments affecting the ambulation test.

- Integumentary impairment: skin breakdown and bedsore around the loading area of the
suspension belt

- No previous robotic intervention for ambulation training

- Significant and persistent mental illness.

- A fixed contracture or deformity in lower extremity.

- Bone instability (non-consolidated fractures, unstable spinal column, severe
osteoporosis necessitating treatment with bisphosphonates).

- Other neurodegenerative disorders (Amyotrophic lateral sclerosis, Parkinsonian
disorder).

- Modified Ashworth scale >3 in affected leg.

- Significant back or leg pain that creates an inability to tolerate movement.

- Decreased sensation that will impair patient's ability to percept whether the device
is properly fitted

- Aphasia of a degree that would prevent the patient from communicating discomfort.

- Inability to tolerate the Walkbot device or ambulation therapy