Clinical trial NCT01626417: Evaluation of Transfer Kinematics and Kinetics in Patients Chronic Post-stroke Using the Tibion Bionic Leg
Official title: A Prospective, Experimental Study to Evaluate Transfer Kinematics and Kinetics of Chronic Post-stroke Patients With Tibion Bionic Leg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Tibion
Bionics
Rehab
Therapy
Robotics
Intention
Lead sponsor: Tibion Bionics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2012-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The objective of this clinical study is to examine the acute kinematics and kinetics of utilizing the Tibion Bionic Leg in a sample of chronic post-stroke patients performing sit-to-stand and stand-to-sit transfers across a range of assistance and resistance settings (internal to the device); to compare these metrics to baseline performance without the Bionic Leg; and to determine the Bionic Leg settings that optimize a restorative (equal force distribution) movement state in these patients.

Detailed description: Comprehensive motion (kinetics and kinematics) data specific to sit-to-stand and stand-to-sit transfers with and without the Tibion Bionic Leg. The Vicon Motion Analysis System will be utilized to track movement using markers on the subject and the Bionic Leg per the UCSF Human Performance Center's routine. Once outfitted with the marker system, patients will be instructed to perform multiple sit-to-stand and stand-to-sit transfers while data is gathered.

The sit-to-stand and stand-to-sit transfers will be performed using a standard chair, with a seat height not less than 12" from the floor. The chair will be positioned such that, at sitting rest, each of the subject's feet are positioned on limb-specific force plates (left and right).

Eligibility criteria: Inclusion Criteria:

* Single ischemic stroke with residual unilateral lower-extremity weakness
* Chronic post-stroke (\>12 months since event)
* Eligible to participate to lower extremity physical therapy
* Age 30 years or greater
* Able to ambulate at least 10 meters without therapist assistance
* Able to ambulate without a leg brace
* Able to transfer from sitting to standing without physical assistance from a therapist
* Able to transfer from standing to sitting without physical assistance from a therapist
* 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 30 years
* Subacute post-stroke (\< 12 months since event)
* Status-post multiple strokes
* Status-post traumatic brain injury
* Not eligible to participate in lower extremity physical therapy
* Concomitant degenerative neurological conditions
* Not able to ambulate at least 10 meters without therapist assistance
* Unable to ambulate without a leg brace
* Unable to transfer from sitting to standing without physical assistance from a therapist
* Unable to transfer from standing to sitting without physical assistance from a therapist
* Unable to follow instructions, complete follow-up, or provide informed consent.
* Currently enrolled in another investigational device or drug trial

Primary outcomes:
measure: Force
timeFrame: Subject participation in the study is up to one (1) week.
Secondary outcomes:
measure: Work
timeFrame: Subject participation in study is up to one (1) week.
measure: Torque
timeFrame: Subject participation is up to one (1) week
measure: Moment
timeFrame: Subject participation is up to one (1) week
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Human Performance Center
state: California
city: Sunnyvale
country: United States
facility: Tibion Corporation
state: California
Study officials:
affiliation: Tibion Corporation
name: Joshua G Vose, 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.