Walkbot Robotic Training for Improvement in Gait

Study Overview
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Brief Summary
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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
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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.

Official Title
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Walkbot Robotic Training for Improvement in Gait in Sub-Acute Stroke

Conditions
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Ischemic Stroke, Gait, Hemiplegic

Intervention / Treatment
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* Device: Walkbot
* Behavioral: Physical Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Sequential randomization into one of two groups within first week after admission.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Walkbot Training<br>This group will 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). | Device: Walkbot<br>* 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.<br>|
| Active Comparator: Physical Therapy<br>This group 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). | Behavioral: Physical Therapy<br>* 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).<br>|
| No Intervention: Usual Care Physical Therapy<br>Participants in this group will receive usual inpatient care including at least one 60-minute session of physical therapy per day. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl Meyer Assessment | Lower extremity impairment measure | Discharge evaluation (within 2 days after last session) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIH Stroke Scale | Quantitative measure of stroke-related neurological deficit; The scale is comprised of 11 items with a maximal score of 42 and minimum of 0. Higher scores indicate severe stroke. | Baseline assessment and discharge evaluation within 2 days after last session | 
| Modified Ashworth Scale | Measure of spasticity; Each muscle assessed is scored between 0-4, with 4 indicating rigid limbs or very severely affected. | Baseline assessment and discharge evaluation within 2 days after last session | 
| Functional Ambulation Classification | Clinical measure of mobility | Baseline assessment and discharge evaluation within 2 days after last session | 
| 6 Minute Walk Test | Measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes. | Baseline assessment and discharge evaluation within 2 days after last session | 
| 10 Meter Walk Test | Examines gait speed | Baseline assessment and discharge evaluation within 2 days after last session | 
| Timed Up and Go | Assesses mobility in both static and dynamic balance | Baseline assessment and discharge evaluation within 2 days after last session | 
| Berg Balance Scale | Assesses balance during a series of 14 tasks; higher scores indicate greater independence. | Baseline assessment and discharge evaluation within 2 days after last session | 
| Burke Lateropulsion Scale | 5 item scale measures lateropulsion or Pusher Syndrome by assessing reaction to change in postural position; 0 = no lateropulsion, 17= maximum score. | Baseline assessment and discharge evaluation within 2 days after last session | 
| Beck Depression Inventory | 21 question, multiple choice, self-report inventory to assess depression; score of 0= minimal depression, 63= severe depression. | Baseline assessment and discharge evaluation within 2 days after last session |