Brief 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.
Brief Title
Walkbot Robotic Training for Improvement in Gait
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Ischemic Stroke
Gait, Hemiplegic
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
99 Years
Minimum Age
18 Years
NCT Id
NCT03554642
Org Class
Other
Org Full Name
Burke Medical Research Institute
Org Study Id
BRC532
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Walkbot Robotic Training for Improvement in Gait in Sub-Acute Stroke
Primary Outcomes
Outcome Description
Lower extremity impairment measure
Outcome Measure
Fugl Meyer Assessment
Outcome Time Frame
Discharge evaluation (within 2 days after last session)
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Baseline assessment and discharge evaluation within 2 days after last session
Outcome Measure
NIH Stroke Scale
Outcome Description
Measure of spasticity; Each muscle assessed is scored between 0-4, with 4 indicating rigid limbs or very severely affected.
Outcome Time Frame
Baseline assessment and discharge evaluation within 2 days after last session
Outcome Measure
Modified Ashworth Scale
Outcome Description
Clinical measure of mobility
Outcome Time Frame
Baseline assessment and discharge evaluation within 2 days after last session
Outcome Measure
Functional Ambulation Classification
Outcome Description
Measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes.
Outcome Time Frame
Baseline assessment and discharge evaluation within 2 days after last session
Outcome Measure
6 Minute Walk Test
Outcome Description
Examines gait speed
Outcome Time Frame
Baseline assessment and discharge evaluation within 2 days after last session
Outcome Measure
10 Meter Walk Test
Outcome Description
Assesses mobility in both static and dynamic balance
Outcome Time Frame
Baseline assessment and discharge evaluation within 2 days after last session
Outcome Measure
Timed Up and Go
Outcome Description
Assesses balance during a series of 14 tasks; higher scores indicate greater independence.
Outcome Time Frame
Baseline assessment and discharge evaluation within 2 days after last session
Outcome Measure
Berg Balance Scale
Outcome Description
5 item scale measures lateropulsion or "Pusher Syndrome" by assessing reaction to change in postural position; 0 = no lateropulsion, 17= maximum score.
Outcome Time Frame
Baseline assessment and discharge evaluation within 2 days after last session
Outcome Measure
Burke Lateropulsion Scale
Outcome Description
21 question, multiple choice, self-report inventory to assess depression; score of 0= minimal depression, 63= severe depression.
Outcome Time Frame
Baseline assessment and discharge evaluation within 2 days after last session
Outcome Measure
Beck Depression Inventory
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
99
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Kathleen Friel
Investigator Email
kaf3001@med.cornell.edu
Investigator Phone