We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01626417
Recruitment Status : Completed
First Posted : June 22, 2012
Last Update Posted : November 14, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

June 18, 2012
June 22, 2012
November 14, 2012
May 2012
November 2012   (Final data collection date for primary outcome measure)
Force [ Time Frame: 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.
Same as current
Complete list of historical versions of study NCT01626417 on ClinicalTrials.gov Archive Site
  • Work [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Same as current
Not Provided
Not Provided
 
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.

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).

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Stroke
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.
No Intervention: Patient Population
Chronic post-stroke subjects with varied impairment level, who have completed routine rehabilitative physical therapy.
Intervention: Device: Tibion Bionic Leg

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2012
November 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01626417
CP 007
No
Not Provided
Not Provided
Tibion Bionics, Inc.
Tibion Bionics, Inc.
University of California, San Francisco
Principal Investigator: Joshua G Vose, MD Tibion Corporation
Tibion Bionics, Inc.
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP