A Phase 3 interventional study of Walkbot and Physical Therapy in Ischemic Stroke and Gait, Hemiplegic, sponsored by Burke Medical Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-01-14.
Sponsored by Burke Medical Research Institute · Phase 3, Interventional, and Treatment
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.
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.
2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.
This study's planned enrollment of 30 is below the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Burke Medical Research Institute is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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
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
Participants in this group will receive usual inpatient care including at least one 60-minute session of physical therapy per day.
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).
Fugl Meyer Assessment
Lower extremity impairment measure
Time frame: Discharge evaluation (within 2 days after last session)
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.
Time frame: 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.
Time frame: Baseline assessment and discharge evaluation within 2 days after last session
Functional Ambulation Classification
Clinical measure of mobility
Time frame: 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.
Time frame: Baseline assessment and discharge evaluation within 2 days after last session
10 Meter Walk Test
Examines gait speed
Time frame: Baseline assessment and discharge evaluation within 2 days after last session
Timed Up and Go
Assesses mobility in both static and dynamic balance
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline assessment and discharge evaluation within 2 days after last session
Plan to share: No — No plan to share individual participant data with other researchers at this time.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Burke Medical Research Institute