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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Tibion Bionic Leg

• Registration Number: NCT01626417
• Lead Sponsor: Tibion Bionics, Inc.

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).

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-18
• Study First Submitted QC: 2012-06-21
• Study First Posted: 2012-06-22
• Status Verified: 2012-11
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Last Update Submitted: 2012-11-13
• Last Update Posted: 2012-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient Population	Tibion Bionic Leg	Chronic post-stroke subjects with varied impairment level, who have completed routine rehabilitative physical therapy.

Primary Outcome Measures

Name	Time	Method
Force	Subject participation in the study is up to one (1) week.	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.

Secondary Outcome Measures

Name	Time	Method
Torque	Subject participation is up to one (1) week	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.
Work	Subject participation in study is up to one (1) week.	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.
Moment	Subject participation is up to one (1) week	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.

Trial Locations

Locations (2)

UCSF Human Performance Center; 🇺🇸 San Francisco, California, United States

Tibion Corporation; 🇺🇸 Sunnyvale, California, United States