Joint Disease Clinical Trial
Official title:
Quantitative Gait Analysis for Clinical Decision Making
The overall purpose of this study is to develop an improved gait analysis system for the
real time acquisition, calculation and interpretation of joint kinematic and kinetic
information using linked segment body model animation to display and visually depict
deviations from normal motion and joint function.
Patients referred to the laboratory for clinical gait analysis are invited to participate in
the project. If interested, subjects are informed by a study investigator of the study
goals, procedures, risks and any benefits. A study investigator is responsible for obtaining
informed consent. Data from normal subjects are used to establish a normative database. Data
from other subjects contributes to the relevant databases of different disorders.
The overall purpose of this study is to develop an improved gait analysis system for the
real time acquisition, calculation and interpretation of joint kinematic and kinetic
information using linked segment body model animation to display and visually depict
deviations from normal motion and joint function.
Subjects will be studied using the standard protocol used for patient evaluations in the
Rehabilitation Medicine Human Motion Laboratory (GBO13 V AH). The standard protocol includes
the routine collection of kinematic data, kinetic data, foot pressure data and, in selected
cases, electromyography information. All collected raw data will ultimately be processed for
relevant biomechanical parameters and utilized to build either a Normative Database or
Non-Normative Database from which selected cases maybe extracted for teaching purposes,
pilot data or software development. The project is not designed to test specific hypothesis
and as such statistical analysis are not planned.
To acquire kinematics data, infrared reflective markers are taped over the joints of the
lower extremities, trunk, and arms. The reflective markers are used in conjunction with the
optoelectronic kinematic motion analysis system (Vicon) to allow acquisition of 3D motion
data for the limb and trunk segments of subjects. Joint kinetics are determine from ground
reaction forces measured by force plates embedded into the floor of the gait laboratory and
requiring no specific subject setup. Foot pressure data is obtained by Fscan. Mylar pressure
sensitive strips are placed in the shoe or residual limb. The strip is connected to a
datalogger and battery pack that will be put on a belt and worn over the shoulder or on the
waist. When electromyographic data is required, surface electrodes are placed over the motor
point regions of selected muscles of the lower extremities.
After placement of markers and recording electrodes, the subjects will be instructed to walk
down the gait lab runway over the force platform. Simultaneous kinematic, EMG and force
plate data is collected. Between 3 and 10 strides of data are collected depending on the
degree of variability in the gait pattern. When assistive devices ( canes etc.) or orthotic
devices are used, the subject may be asked to ambulate with and without the gait aid.
Since the patients recruited for this study will have abnormalities in their gait, the most
significant risk is falling. Therefore, subjects will be screened to ensure that they can
ambulate independently over level ground. During testing, standby assistance will be present
to help subjects in cases of balance loss. The risks for normal subjects are negligible.
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