Walkbot Robotic Training for Improvement in Gait

Completed · Phase 3

Conditions studied: Ischemic Stroke, Gait, Hemiplegic

In brief

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.

Key facts

Study ID

NCT03554642

Run by

Burke Medical Research Institute

People needed

30

Starts

2016-09-01

Expected to finish

2019-12-01

Last updated by the study team

2020-01-14

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Burke Medical Research Institute — White Plains, New York, United States

Full record on ClinicalTrials.gov

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