Evaluation of Transfer Kinematics and Kinetics in Patients Chronic Post-stroke Using the Tibion Bionic Leg

Completed · Not applicable

Conditions studied: Stroke

In brief

The objective of this clinical study is to examine the acute kinematics and kinetics of utilizing the Tibion Bionic Leg in a sample of chronic post-stroke patients performing sit-to-stand and stand-to-sit transfers across a range of assistance and resistance settings (internal to the device); to compare these metrics to baseline performance without the Bionic Leg; and to determine the Bionic Leg settings that optimize a restorative (equal force distribution) movement state in these patients.

Key facts

Study ID

NCT01626417

Run by

Tibion Bionics, Inc.

People needed

20

Starts

2012-05-01

Expected to finish

2012-11-01

Last updated by the study team

2012-11-14

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Single ischemic stroke with residual unilateral lower-extremity weakness
• Chronic post-stroke (>12 months since event)
• Eligible to participate to lower extremity physical therapy
• Age 30 years or greater
• Able to ambulate at least 10 meters without therapist assistance
• Able to ambulate without a leg brace
• Able to transfer from sitting to standing without physical assistance from a therapist
• Able to transfer from standing to sitting without physical assistance from a therapist
• 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

You may not qualify if…

• Medically unstable
• Age younger than 30 years
• Subacute post-stroke (< 12 months since event)
• Status-post multiple strokes
• Status-post traumatic brain injury
• Not eligible to participate in lower extremity physical therapy
• Concomitant degenerative neurological conditions
• Not able to ambulate at least 10 meters without therapist assistance
• Unable to ambulate without a leg brace
• Unable to transfer from sitting to standing without physical assistance from a therapist
• Unable to transfer from standing to sitting without physical assistance from a therapist
• Unable to follow instructions, complete follow-up, or provide informed consent.
• Currently enrolled in another investigational device or drug trial

Where it is running

• UCSF Human Performance Center — San Francisco, California, United States
• Tibion Corporation — Sunnyvale, California, United States

Full record on ClinicalTrials.gov

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