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

Sponsor

Tibion Bionics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01626417

Collaborator

University of California, San Francisco (Other)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Tibion Bionic Leg	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Patient Population Chronic post-stroke subjects with varied impairment level, who have completed routine rehabilitative physical therapy.	Device: Tibion Bionic Leg 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.

Arm

Intervention/Treatment

No Intervention: Patient Population

Chronic post-stroke subjects with varied impairment level, who have completed routine rehabilitative physical therapy.

Device: Tibion Bionic Leg

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.

Outcome Measures

Primary Outcome Measures

Force [Subject participation in the study is up to one (1) week.]
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.

Secondary Outcome Measures

Work [Subject participation in study is up to one (1) week.]
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.
Torque [Subject participation is up to one (1) week]
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.
Moment [Subject participation is up to one (1) week]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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