Evaluation of Transfer Kinematics and Kinetics in Patients Chronic Post-stroke Using the Tibion Bionic Leg

Stroke Clinical Trial

Official title:

A Prospective, Experimental Study to Evaluate Transfer Kinematics and Kinetics of Chronic Post-stroke Patients With Tibion Bionic Leg

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01626417
• Other study ID #: CP 007
• Status: Completed
• Phase: N/A
• First received: June 18, 2012
• Last updated: November 13, 2012
• Start date: May 2012
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Tibion Bionics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Tibion Bionic Leg
The device is a lightweight, wearable, portable, battery-powered, robotic leg orthosis that provides active assistance and resistance to lower limb movement according to the patient's intent to move.

Locations

Country	Name	City	State
United States	UCSF Human Performance Center	San Francisco	California
United States	Tibion Corporation	Sunnyvale	California

Sponsors (2)

Lead Sponsor	Collaborator
Tibion Bionics, Inc.	University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (3)

Horst RW, Marcus RR. FlexCVA: a continuously variable actuator for active orthotics. Conf Proc IEEE Eng Med Biol Soc. 2006;1:2425-8. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Force	Force, in Newtons (N), by limb, as measured by kinematic and kinetic analysis during sit-to-stand and stand-to-sit transfers with and without the Tibion Bionic Leg.	Subject participation in the study is up to one (1) week.	Yes
Secondary	Work	Work, in Joules (J), by limb, as measured by kinematic and kinetic analysis during sit-to-stand and stand-to-sit transfers with and without the Tibion Bionic Leg.	Subject participation in study is up to one (1) week.	Yes
Secondary	Torque	Torque, in Newton-meters (N-m), at the ankle and knee, by limb, as measured by kinematic and kinetic analysis during sit-to-stand and stand-to-sit transfers with and without the Tibion Bionic Leg.	Subject participation is up to one (1) week	Yes
Secondary	Moment	Moment at the ankle and knee in Newtons (N), by limb, as measured by kinematic and kinetic analysis during sit-to-stand and stand-to-sit transfers with and without the Tibion Bionic Leg.	Subject participation is up to one (1) week	No

External Links

•   Tibion Bionic Leg