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

This study has been terminated.
(Study was terminated base on Sponsor's decision.)
Sponsor:
Information provided by (Responsible Party):
Tibion Bionics, Inc.
ClinicalTrials.gov Identifier:
NCT01558232
First received: March 6, 2012
Last updated: July 5, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Stroke
Device: Tibion Bionic Leg

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Experimental ABA Study to Evaluate Use of the Tibion Bionic Leg in Subacute Post-stroke Patients Undergoing Physical Therapy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Ambulation Speed [ Time Frame: Baseline (prior to training); at conclusion of training regimen, an average of 2 weeks. ] [ Designated as safety issue: Yes ]
    Walking speed (comfortable and fastest possible), in meters per second, as measured by the 10 Meter Walk Test (10 MWT).


Secondary Outcome Measures:
  • Measurements of Gait [ Time Frame: 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. ] [ Designated as safety issue: Yes ]

    The secondary endpoints are obtained from the GAITRite analysis system:

    • Measurements of gait, such as the length and time of step, cycle, and stride, Heel to Heel base support, single/double limb support time, and stance and swing phase timing.

  • Measurements of Stride [ Time Frame: 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. ] [ Designated as safety issue: Yes ]

    Other secondary endpoints are obtained from the GAITRite analysis system:

    • Measurements of Stride such as distance, ambulation time, velocity, normalized velocity, cadence, step time, step length, cycle time.

  • Measurements of Force, Stance, and Stability [ Time Frame: 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. ] [ Designated as safety issue: Yes ]

    Other secondary endpoints are obtained from Balance Master system:

    • Limb parameters, including force in transfers from sitting to standing, standing to sitting, weight-bearing squats, and limits of stability.


Enrollment: 10
Study Start Date: March 2012
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tibion Arm
Arm of the study in which enrolled subacute post-stroke subjects undergo lower extremity physical therapy using the Tibion Bionic Leg.
Device: Tibion Bionic Leg
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).

Detailed Description:

Samples text.

  Eligibility

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

Inclusion Criteria:

  • Single stroke with residual unilateral lower-extremity weakness
  • Subacute post-stroke period (>3 and <12 months)
  • Eligible to participate to lower extremity physical therapy
  • Age 40 years or greater
  • Able to ambulate at least 10 meters
  • Able to ambulate without a leg brace
  • Ambulation speed less than 0.8 meters/second
  • Minimum to moderate assist for transfer or ambulation by physical therapist evaluation
  • Subject must understand the nature of the study and provide written informed consent prior to enrollment.
  • Subject must be willing and able to attend all study sessions

Exclusion Criteria:

  • Medically unstable
  • Age younger than 40 years
  • Acute post-stroke (< 3 months)
  • Chronic post-stroke (> 12 months)
  • Status-post multiple strokes
  • Status-post traumatic brain injury
  • Ambulation speed greater than 0.8 meters/second
  • Currently using a Knee-Ankle-Foot Orthosis (KAFO)
  • Not eligible for lower extremity physical therapy
  • Concomitant degenerative neurological conditions
  • Not able to ambulate at least 10 meters without assistance
  • Greater than moderate assist during transfer or ambulation by physical therapist evaluation
  • Unable to ambulate without a leg brace
  • Unable to follow instructions, complete follow-up, or provide informed consent.
  • Currently enrolled in another investigational device or drug trial
  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: NCT01558232

Locations
United States, Pennsylvania
Magee Rehabilitation Hospital
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Tibion Bionics, Inc.
Investigators
Principal Investigator: Barbara Browne, MD Magee Rehabilitation Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Tibion Bionics, Inc.
ClinicalTrials.gov Identifier: NCT01558232     History of Changes
Other Study ID Numbers: CP001
Study First Received: March 6, 2012
Last Updated: July 5, 2012
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 14, 2014