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

Completed

Phase N/A Results N/A

Trial Description

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.

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).

Conditions

Interventions

  • Tibion Bionic Leg Device
    Intervention Desc: 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 1: Kind: Experimental
    Label: Patient Population
    Description: Chronic post-stroke subjects with varied impairment level, who have completed routine rehabilitative physical therapy.

Trial Design

  • Masking: Open Label
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Force Subject participation in the study is up to one (1) week. Yes
Secondary Work Subject participation in study is up to one (1) week. Yes
Secondary Torque Subject participation is up to one (1) week Yes
Secondary Moment Subject participation is up to one (1) week No

Sponsors