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Completed

NCT Number: NCT01499862

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

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).

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bakar Community Center at the University of California San Francisco

San Francisco, California, 94158-2332, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Tibion Bionic Leg

Device

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.

Primary outcomes

  1. 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.

    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 outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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.

    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)

  4. 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.

    The length of the patient's average step, in meters, as measured during comfortable walking.

Sponsors and collaborators

Lead sponsor

Tibion Bionics, Inc.

Industry

Collaborators

  • University of California, San Francisco

Registry information

Official study title

Discriminatory Neurosensory Stimulation Neurological H5394-11417-15

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 26, 2011
Registry last updated
Aug 2, 2013

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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