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

Primary Purpose

Stroke

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tibion Bionic Leg
Sponsored by
Tibion Bionics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Tibion, Bionics, Rehab, Therapy, Robotics, Intention

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Magee Rehabilitation Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tibion Arm

Arm Description

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

Outcomes

Primary Outcome Measures

Ambulation Speed
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
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
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
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.

Full Information

First Posted
March 6, 2012
Last Updated
July 5, 2012
Sponsor
Tibion Bionics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01558232
Brief Title
A Prospective Study to Evaluate Use of the Tibion Bionic Leg in Sub-Acute Post-stroke Patients
Acronym
Acute Effects
Official Title
A Prospective, Experimental ABA Study to Evaluate Use of the Tibion Bionic Leg in Subacute Post-stroke Patients Undergoing Physical Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated base on Sponsor's decision.
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tibion Bionics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Samples text.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Tibion, Bionics, Rehab, Therapy, Robotics, Intention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tibion Arm
Arm Type
Experimental
Arm Description
Arm of the study in which enrolled subacute post-stroke subjects undergo lower extremity physical therapy using the Tibion Bionic Leg.
Intervention Type
Device
Intervention Name(s)
Tibion Bionic Leg
Intervention Description
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).
Primary Outcome Measure Information:
Title
Ambulation Speed
Description
Walking speed (comfortable and fastest possible), in meters per second, as measured by the 10 Meter Walk Test (10 MWT).
Time Frame
Baseline (prior to training); at conclusion of training regimen, an average of 2 weeks.
Secondary Outcome Measure Information:
Title
Measurements of Gait
Description
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.
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.
Title
Measurements of Stride
Description
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.
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.
Title
Measurements of Force, Stance, and Stability
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Browne, MD
Organizational Affiliation
Magee Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magee Rehabilitation Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22082495
Citation
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.
Results Reference
background
PubMed Identifier
19964374
Citation
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.
Results Reference
background
PubMed Identifier
17946511
Citation
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.
Results Reference
background
Links:
URL
http://www.tibion.com
Description
Tibion Bionic Leg

Learn more about this trial

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

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