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

• Measurements of Gait [ Time Frame: Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks. ] [ Designated as safety issue: Yes ]

  The secondary endpoints are obtained from the GAITRite analysis system:

  • Measurements of gait, such as the length and time of step, cycle, and stride, Heel to Heel base support, single/double limb support time, and stance and swing phase timing.
• Measurements of Stride [ Time Frame: Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks. ] [ Designated as safety issue: Yes ]

  Other secondary endpoints are obtained from the GAITRite analysis system:

  • Measurements of Stride such as distance, ambulation time, velocity, normalized velocity, cadence, step time, step length, cycle time.
• Measurements of Force, Stance, and Stability [ Time Frame: Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks. ] [ Designated as safety issue: Yes ]

  Other secondary endpoints are obtained from Balance Master system:

  • Limb parameters, including force in transfers from sitting to standing, standing to sitting, weight-bearing squats, and limits of stability.

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.

Samples text.

• Wong CK, Bishop L, Stein J. A wearable robotic knee orthosis for gait training: a case-series of hemiparetic stroke survivors. Prosthet Orthot Int. 2011 Nov 14; [Epub ahead of print]
• Horst RW. A bio-robotic leg orthosis for rehabilitation and mobility enhancement. Conf Proc IEEE Eng Med Biol Soc. 2009;2009:5030-3.
• Horst RW, Marcus RR. FlexCVA: a continuously variable actuator for active orthotics. Conf Proc IEEE Eng Med Biol Soc. 2006;1:2425-8.

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