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Completed

NCT Number: NCT01626417

Evaluation of Transfer Kinematics and Kinetics in Patients Chronic Post-stroke Using the 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.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Human Performance Center, San Francisco, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tibion Bionic Leg

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Tibion Bionics, Inc.

Industry

Collaborators

  • University of California, San Francisco

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 22, 2012
Registry last updated
Nov 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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