Mobility Training Using a Bionic Knee Orthosis in Patients Chronic Post-Stroke: A Case Series

Completed

Phase 4 Results

Trial Description

This pilot study examined the effect of task-oriented mobility training in three persons chronic post-stroke using a novel, wearable, mobile intention-based robotic orthosis (Tibion Bionic Leg).

Conditions

Interventions

  • Tibion Bionic Leg Device
    Intervention Desc: A programmable, carbon-fiber robotic leg orthosis (Tibion Bionic Leg, Tibion Corporation, Sunnyvale, CA) was used during therapy to actively supplement concentric and eccentric quadriceps function on the participant's impaired side. The device uses internal sensors at the foot and knee joint to detect intention of movement and, once a variable force threshold is passed, the devices provides appropriate assistive and resistive adjustments.
    ARM 1: Kind: Experimental
    Label: Tibion Arm
    Description: Arm of the study in which enrolled post-stroke subjects undergo rehabilitative therapy with 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 Change in time from Baseline to walk ten (10) meters (10 Meter Walk Test) Baseline (prior to training); at conclusion of training regimen, an average of 18 weeks; 1 Month post-training Yes
Secondary Change in distance from baseline walked over six (6) minutes (6 Minute Walk Test) Baseline (prior to training); at conclusion of training regimen, an average of 18 weeks; 1 Month post-training Yes
Secondary Change from baseline in time to rise from seated chair position, walk three (3) meters, turn, walk back to chair, and sit down (Timed Up and Go Test) Baseline (prior to training); at conclusion of training regimen, an average of 18 weeks; 1 Month post-training Yes
Secondary Change in time from baseline to complete the Five Times Sit to Stand Test (explained below) Baseline (prior to training); at conclusion of training regimen, an average of 18 weeks; 1 Month post-training Yes
Secondary Change in length from baseline of average step length (Step Length Test) Baseline (prior to training); at conclusion of training regimen, an average of 18 weeks; 1 Month post-training Yes
Primary Ambulation Speed Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen. Yes
Secondary 6 Minute Walk Test (6 MWT) Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen. Yes
Secondary Timed Up and Go (TUG) Test Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen. Yes
Secondary Five Times Sit to Stand Test (5 x STS) Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen. Yes
Secondary Step Length Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen. Yes

Sponsors