Clinical trial NCT03554642: Walkbot Robotic Training for Improvement in Gait
Official title: Walkbot Robotic Training for Improvement in Gait in Sub-Acute Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ischemic Stroke
Gait, Hemiplegic
Lead sponsor: Burke Medical Research Institute
Sponsor class: OTHER
Collaborators: name: P&S Mechanics Co., Ltd.
First posted: 2018-06-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sequential randomization into one of two groups within first week after admission.
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Fugl Meyer Assessment
timeFrame: Discharge evaluation (within 2 days after last session)
Secondary outcomes:
measure: NIH Stroke Scale
timeFrame: Baseline assessment and discharge evaluation within 2 days after last session
measure: Modified Ashworth Scale
timeFrame: Baseline assessment and discharge evaluation within 2 days after last session
measure: Functional Ambulation Classification
timeFrame: Baseline assessment and discharge evaluation within 2 days after last session
measure: 6 Minute Walk Test
timeFrame: Baseline assessment and discharge evaluation within 2 days after last session
measure: 10 Meter Walk Test
timeFrame: Baseline assessment and discharge evaluation within 2 days after last session
measure: Timed Up and Go
timeFrame: Baseline assessment and discharge evaluation within 2 days after last session
measure: Berg Balance Scale
timeFrame: Baseline assessment and discharge evaluation within 2 days after last session
measure: Burke Lateropulsion Scale
timeFrame: Baseline assessment and discharge evaluation within 2 days after last session
measure: Beck Depression Inventory
timeFrame: Baseline assessment and discharge evaluation within 2 days after last session
Other outcomes:
Locations:
city: White Plains
country: United States
facility: Burke Medical Research Institute
state: New York
Study officials:
affiliation: Burke Medical Research Institute
name: Kathleen Friel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.