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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Tibion Bionic Leg

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • UCSF Human Performance Center
    • Sunnyvale, California, United States, 94085
      • Tibion Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

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

Collaborators and Investigators

• Sponsor: Tibion Bionics, Inc.
• Collaborators: University of California, San Francisco
• Investigators: Principal Investigator: Joshua G Vose, MD, Tibion Corporation

Publications and helpful links

General Publications

• Wong CK, Bishop L, Stein J. A wearable robotic knee orthosis for gait training: a case-series of hemiparetic stroke survivors. Prosthet Orthot Int. 2012 Mar;36(1):113-20. doi: 10.1177/0309364611428235. Epub 2011 Nov 14.
• Horst RW. A bio-robotic leg orthosis for rehabilitation and mobility enhancement. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:5030-3. doi: 10.1109/IEMBS.2009.5333581.
• Horst RW, Marcus RR. FlexCVA: a continuously variable actuator for active orthotics. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:2425-8. doi: 10.1109/IEMBS.2006.259950.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: June 18, 2012
• First Submitted That Met QC Criteria: June 21, 2012
• First Posted (Estimate): June 22, 2012

Study Record Updates

• Last Update Posted (Estimate): November 14, 2012
• Last Update Submitted That Met QC Criteria: November 13, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Stroke; Robotics; Therapy; Tibion; Bionics; Rehab; Intention
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: CP 007