A Prospective Study to Evaluate Use of the Tibion Bionic Leg in Sub-Acute Post-stroke Patients

A Prospective, Experimental ABA Study to Evaluate Use of the Tibion Bionic Leg in Subacute Post-stroke Patients Undergoing Physical Therapy

The objective of this clinical study is to examine acute changes in stability, force allocation, work, and mobility from using a wearable, portable, battery-operated robotic orthosis (the Tibion Bionic Leg) in subacute post-stroke persons undergoing lower extremity physical therapy.

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Inclusion Criteria:

• Single stroke with residual unilateral lower-extremity weakness
• Subacute post-stroke period (>3 and <12 months)
• Eligible to participate to lower extremity physical therapy
• Age 40 years or greater
• Able to ambulate at least 10 meters
• Able to ambulate without a leg brace
• Ambulation speed less than 0.8 meters/second
• Minimum to moderate assist for transfer or ambulation by physical therapist evaluation
• Subject must understand the nature of the study and provide written informed consent prior to enrollment.
• Subject must be willing and able to attend all study sessions

Exclusion Criteria:

• Medically unstable
• Age younger than 40 years
• Acute post-stroke (< 3 months)
• Chronic post-stroke (> 12 months)
• Status-post multiple strokes
• Status-post traumatic brain injury
• Ambulation speed greater than 0.8 meters/second
• Currently using a Knee-Ankle-Foot Orthosis (KAFO)
• Not eligible for lower extremity physical therapy
• Concomitant degenerative neurological conditions
• Not able to ambulate at least 10 meters without assistance
• Greater than moderate assist during transfer or ambulation by physical therapist evaluation
• Unable to ambulate without a leg brace
• Unable to follow instructions, complete follow-up, or provide informed consent.
• Currently enrolled in another investigational device or drug trial