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

Tibion Bionics

Status: Terminated

Conditions: Stroke

Treatments: Device: Tibion Bionic Leg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01558232

CP001

Details and patient eligibility

About

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.

Full description

Samples text.

Enrollment: 10 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Tibion Arm

Experimental group

Description:

Arm of the study in which enrolled subacute post-stroke subjects undergo lower extremity physical therapy using the Tibion Bionic Leg.

Treatment:

Device: Tibion Bionic Leg