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| Name | Class |
|---|---|
| P&S Mechanics Co., Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Walkbot Training | Experimental | 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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| Physical Therapy | Active Comparator | 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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| Usual Care Physical Therapy | No Intervention | Participants in this group will receive usual inpatient care including at least one 60-minute session of physical therapy per day. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walkbot | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl Meyer Assessment | Lower extremity impairment measure | Discharge evaluation (within 2 days after last session) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Friel, PhD | Burke Medical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Medical Research Institute | White Plains | New York | 10605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34819515 | Derived | Park C, Oh-Park M, Bialek A, Friel K, Edwards D, You JSH. Abnormal synergistic gait mitigation in acute stroke using an innovative ankle-knee-hip interlimb humanoid robot: a preliminary randomized controlled trial. Sci Rep. 2021 Nov 24;11(1):22823. doi: 10.1038/s41598-021-01959-z. |
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No plan to share individual participant data with other researchers at this time.
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020233 | Gait Disorders, Neurologic |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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Sequential randomization into one of two groups within first week after admission.
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| Physical Therapy | Behavioral | 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). |
|
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 |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |