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

This study has been completed.
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Tibion Bionics, Inc.
ClinicalTrials.gov Identifier:
NCT01626417
First received: June 18, 2012
Last updated: November 13, 2012
Last verified: November 2012
  Purpose

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 Intervention
Stroke
Device: Tibion Bionic Leg

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Prospective, Experimental Study to Evaluate Transfer Kinematics and Kinetics of Chronic Post-stroke Patients With Tibion Bionic Leg

Resource links provided by NLM:


Further study details as provided by Tibion Bionics, Inc.:

Primary Outcome Measures:
  • Force [ Time Frame: Subject participation in the study is up to one (1) week. ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Subject participation in study is up to one (1) week. ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: May 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626417

Locations
United States, California
UCSF Human Performance Center
San Francisco, California, United States, 94158
Tibion Corporation
Sunnyvale, California, United States, 94085
Sponsors and Collaborators
Tibion Bionics, Inc.
University of California, San Francisco
Investigators
Principal Investigator: Joshua G Vose, MD Tibion Corporation
  More Information

Additional Information:
Publications:
Responsible Party: Tibion Bionics, Inc.
ClinicalTrials.gov Identifier: NCT01626417     History of Changes
Other Study ID Numbers: CP 007
Study First Received: June 18, 2012
Last Updated: November 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Tibion Bionics, Inc.:
Stroke
Tibion
Bionics
Rehab
Therapy
Robotics
Intention

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 17, 2014