A Prospective Study to Evaluate Use of the Tibion Bionic Leg in Sub-Acute Post-stroke Patients "Acute Effects"

Terminated

Phase N/A Results N/A

Trial Description

The objective of this clinical study is to examine acute changes in stability, force allocation, work, and mobility from using a wearable, portable, battery-operated robotic orthosis (the Tibion Bionic Leg) in subacute post-stroke persons undergoing lower extremity physical therapy.

Detailed Description

Samples text.

Trial Stopped: Study was terminated base on Sponsor's decision.

Conditions

Interventions

  • Tibion Bionic Leg Device
    Intervention Desc: The Tibion Bionic Leg is used as an adjunct in post-stroke and post-operative rehabilitative physical therapy. The leg is a lightweight, wearable, portable, battery-powered, motorized leg orthosis that provides active assistance and resistance to lower limb movement during walking, stair ascent and descent, and transfers from sitting to standing (and standing to sitting).
    ARM 1: Kind: Experimental
    Label: Tibion Arm
    Description: Arm of the study in which enrolled subacute post-stroke subjects undergo lower extremity physical therapy using the Tibion Bionic Leg.

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Ambulation Speed Baseline (prior to training); at conclusion of training regimen, an average of 2 weeks. Yes
Secondary Measurements of Gait Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks. Yes
Secondary Measurements of Stride Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks. Yes
Secondary Measurements of Force, Stance, and Stability Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks. Yes

Sponsors