Clinical trial NCT01558232: A Prospective Study to Evaluate Use of the Tibion Bionic Leg in Sub-Acute Post-stroke Patients
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
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Tibion
Bionics
Rehab
Therapy
Robotics
Intention
Lead sponsor: Tibion Bionics, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-20
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Ambulation Speed
timeFrame: Baseline (prior to training); at conclusion of training regimen, an average of 2 weeks.
Secondary outcomes:
measure: Measurements of Gait
timeFrame: 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.
measure: Measurements of Stride
timeFrame: 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.
measure: Measurements of Force, Stance, and Stability
timeFrame: 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 outcomes:
Locations:
city: Philadelphia
country: United States
facility: Magee Rehabilitation Hospital
state: Pennsylvania
Study officials:
affiliation: Magee Rehabilitation Hospital
name: Barbara Browne, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.