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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
Comprehensive motion (kinetics and kinematics) data specific to sit-to-stand and stand-to-sit transfers with and without the Tibion Bionic Leg. The Vicon Motion Analysis System will be utilized to track movement using markers on the subject and the Bionic Leg per the UCSF Human Performance Center's routine. Once outfitted with the marker system, patients will be instructed to perform multiple sit-to-stand and stand-to-sit transfers while data is gathered. The sit-to-stand and stand-to-sit transfers will be performed using a standard chair, with a seat height not less than 12 from the floor. The chair will be positioned such that, at sitting rest, each of the subject's feet are positioned on limb-specific force plates (left and right).

Official Title
-----------------
A Prospective, Experimental Study to Evaluate Transfer Kinematics and Kinetics of Chronic Post-stroke Patients With Tibion Bionic Leg

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: Tibion Bionic Leg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Patient Population<br>Chronic post-stroke subjects with varied impairment level, who have completed routine rehabilitative physical therapy. | Device: Tibion Bionic Leg<br>* The device is a lightweight, wearable, portable, battery-powered, robotic leg orthosis that provides active assistance and resistance to lower limb movement according to the patient's intent to move.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Force | Force, in Newtons (N), by limb, as measured by kinematic and kinetic analysis during sit-to-stand and stand-to-sit transfers with and without the Tibion Bionic Leg. | Subject participation in the study is up to one (1) week. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work | Work, in Joules (J), by limb, as measured by kinematic and kinetic analysis during sit-to-stand and stand-to-sit transfers with and without the Tibion Bionic Leg. | Subject participation in study is up to one (1) week. | 
| Torque | Torque, in Newton-meters (N-m), at the ankle and knee, by limb, as measured by kinematic and kinetic analysis during sit-to-stand and stand-to-sit transfers with and without the Tibion Bionic Leg. | Subject participation is up to one (1) week | 
| Moment | Moment at the ankle and knee in Newtons (N), by limb, as measured by kinematic and kinetic analysis during sit-to-stand and stand-to-sit transfers with and without the Tibion Bionic Leg. | Subject participation is up to one (1) week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Tibion, Bionics, Rehab, Therapy, Robotics, Intention