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

Overview

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.

Full Title of Study: “A Prospective, Experimental ABA Study to Evaluate Use of the Tibion Bionic Leg in Subacute Post-stroke Patients Undergoing Physical Therapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2012

Detailed Description

Samples text.

Interventions

  • 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).

Arms, Groups and Cohorts

  • Experimental: Tibion Arm
    • Arm of the study in which enrolled subacute post-stroke subjects undergo lower extremity physical therapy using the Tibion Bionic Leg.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary 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.
    • 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.
    • 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.
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tibion Bionics, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Barbara Browne, MD, Principal Investigator, Magee Rehabilitation Hospital

References

Wong CK, Bishop L, Stein J. A wearable robotic knee orthosis for gait training: a case-series of hemiparetic stroke survivors. Prosthet Orthot Int. 2012 Mar;36(1):113-20. doi: 10.1177/0309364611428235. Epub 2011 Nov 14.

Horst RW. A bio-robotic leg orthosis for rehabilitation and mobility enhancement. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:5030-3. doi: 10.1109/IEMBS.2009.5333581.

Horst RW, Marcus RR. FlexCVA: a continuously variable actuator for active orthotics. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:2425-8. doi: 10.1109/IEMBS.2006.259950.

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