Quantitative Gait Analysis for Clinical Decision Making

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00223353
First received: September 13, 2005
Last updated: February 15, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Joint Disease
Musculoskeletal Equilibrium
Other: Prosthetics, Orthotics and Physical Therapy

Study Type: Observational
Official Title: Quantitative Gait Analysis for Clinical Decision Making

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Gait Parameters [ Time Frame: Not a clinical trial. Study closed to enrollment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Balance [ Time Frame: Not a clinical trial. Study closed to enrollment. ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: November 1998
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Lower Limb Amputee Other: Prosthetics, Orthotics and Physical Therapy
Gait Analysis.
Amputee and Normals and Clinical Case Study

Amputee:

Lower limb below/above knee amputee

Normals:

Health adult

Clinical Case Study:

Individual case studies

Other: Prosthetics, Orthotics and Physical Therapy
Gait Analysis.

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adults aged 18-75

Criteria

Inclusion Criteria:

  • Since it is desirable to include the spectrum of gait disorders that are typically encountered in clinical practice, inclusion/exclusion criterion for patients are limited.

Exclusion Criteria:

  • Patients must be able to walk independently with or without assistive devices.
  • Normal subjects must have no history of neuromuscular or musculoskeletal disorders that interfere with ambulation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223353

Locations
United States, Texas
South Texas Veterans Healthcare System
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Nicolas Walsh, MD The University of Texas Health Science Center at San Antonio
  More Information

No publications provided

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00223353     History of Changes
Other Study ID Numbers: 978-0011-149
Study First Received: September 13, 2005
Last Updated: February 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:
Biomechanics
Gait
Balance

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 16, 2014