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

This study has been completed.
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Tibion Bionics, Inc.
ClinicalTrials.gov Identifier:
NCT01499862
First received: December 20, 2011
Last updated: June 30, 2013
Last verified: June 2013
  Purpose

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).


Condition Intervention Phase
Stroke
Device: Tibion Bionic Leg
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Discriminatory Neurosensory Stimulation Neurological H5394-11417-15

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

Primary Outcome Measures:
  • Ambulation Speed [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    Ambulation speed, in meters per second, as obtained by the Ten (10) Meter Walk Test (10 MWT). The 10 MWT measures the time required to walk 10 meters at the subject's comfortable walking pace.


Secondary Outcome Measures:
  • 6 Minute Walk Test (6 MWT) [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    The total distance walked by the patient, in meters, as obtained by the Six (6) Minute Walk Test (6 MWT). The 6 MWT is performed over level ground, using any walking aids (canes, walkers, etc.) the patient requires for comfortable walking.

  • Timed Up and Go (TUG) Test [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    The time, in seconds, for the patient to rise from sitting in a standard arm chair, walk 3 meters, turn around, walk back to the chair, and sit down. This evaluation is called the Timed Up and Go test (TUG). The patient may wear their usual footwear and use any aids (canes, walkers, etc.) they typically employ for comfortable walking.

  • Five Times Sit to Stand Test (5 x STS) [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    The time, in seconds, for the patient to rise from a seated to full standing position and return to sitting five times in rapid succession. This evaluation is called the Five Times Sit to Stand Test (5 x STS)

  • Step Length [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    The length of the patient's average step, in meters, as measured during comfortable walking.


Enrollment: 3
Study Start Date: June 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tibion Arm
Arm of the study in which enrolled post-stroke subjects undergo rehabilitative therapy with the Tibion Bionic Leg.
Device: Tibion Bionic Leg
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.

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female
  • Aged 40 to 60 years
  • One year status post-stroke
  • Able to walk at least 10 meters
  • Independence in self-care

Exclusion Criteria:

  • Medically unstable
  • Major cardiopulmonary deficiency
  • Major depression
  • Significant cognitive deficit
  • Currently receiving gait training
  • Younger than 40 years of age
  • Older than 60 years of age
  • Unable to walk at least 10 meters
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499862

Locations
United States, California
Bakar Community Center at the University of California San Francisco
San Francisco, California, United States, 94158-2332
Sponsors and Collaborators
Tibion Bionics, Inc.
University of California, San Francisco
Investigators
Principal Investigator: Nancy N Byl, PhD, PT University of California, San Francisco
  More Information

Additional Information:
Publications:
Responsible Party: Tibion Bionics, Inc.
ClinicalTrials.gov Identifier: NCT01499862     History of Changes
Other Study ID Numbers: CP 0003
Study First Received: December 20, 2011
Results First Received: June 18, 2012
Last Updated: June 30, 2013
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 September 30, 2014