- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03554642
Walkbot Robotic Training for Improvement in Gait
Walkbot Robotic Training for Improvement in Gait in Sub-Acute Stroke
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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New York
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White Plains, New York, United States, 10605
- Burke Medical Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Walkbot Training
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).
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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.
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Active Comparator: Physical Therapy
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).
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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).
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No Intervention: Usual Care Physical Therapy
Participants in this group will receive usual inpatient care including at least one 60-minute session of physical therapy per day.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fugl Meyer Assessment
Time Frame: Discharge evaluation (within 2 days after last session)
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Lower extremity impairment measure
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Discharge evaluation (within 2 days after last session)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NIH Stroke Scale
Time Frame: Baseline assessment and discharge evaluation within 2 days after last session
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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.
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Baseline assessment and discharge evaluation within 2 days after last session
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Modified Ashworth Scale
Time Frame: Baseline assessment and discharge evaluation within 2 days after last session
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Measure of spasticity; Each muscle assessed is scored between 0-4, with 4 indicating rigid limbs or very severely affected.
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Baseline assessment and discharge evaluation within 2 days after last session
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Functional Ambulation Classification
Time Frame: Baseline assessment and discharge evaluation within 2 days after last session
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Clinical measure of mobility
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Baseline assessment and discharge evaluation within 2 days after last session
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6 Minute Walk Test
Time Frame: Baseline assessment and discharge evaluation within 2 days after last session
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Measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes.
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Baseline assessment and discharge evaluation within 2 days after last session
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10 Meter Walk Test
Time Frame: Baseline assessment and discharge evaluation within 2 days after last session
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Examines gait speed
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Baseline assessment and discharge evaluation within 2 days after last session
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Timed Up and Go
Time Frame: Baseline assessment and discharge evaluation within 2 days after last session
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Assesses mobility in both static and dynamic balance
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Baseline assessment and discharge evaluation within 2 days after last session
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Berg Balance Scale
Time Frame: Baseline assessment and discharge evaluation within 2 days after last session
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Assesses balance during a series of 14 tasks; higher scores indicate greater independence.
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Baseline assessment and discharge evaluation within 2 days after last session
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Burke Lateropulsion Scale
Time Frame: Baseline assessment and discharge evaluation within 2 days after last session
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5 item scale measures lateropulsion or "Pusher Syndrome" by assessing reaction to change in postural position; 0 = no lateropulsion, 17= maximum score.
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Baseline assessment and discharge evaluation within 2 days after last session
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Beck Depression Inventory
Time Frame: Baseline assessment and discharge evaluation within 2 days after last session
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21 question, multiple choice, self-report inventory to assess depression; score of 0= minimal depression, 63= severe depression.
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Baseline assessment and discharge evaluation within 2 days after last session
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kathleen Friel, PhD, Burke Medical Research Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BRC532
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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