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Quantitative Gait Analysis for Clinical Decision Making

Primary Purpose

Joint Disease, Musculoskeletal Equilibrium

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Prosthetics, Orthotics and Physical Therapy
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Joint Disease focused on measuring Biomechanics, Gait, Balance

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • South Texas Veterans Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Arm Label

Lower Limb Amputee

Amputee and Normals and Clinical Case Study

Arm Description

Amputee: Lower limb below/above knee amputee Normals: Health adult Clinical Case Study: Individual case studies

Outcomes

Primary Outcome Measures

Gait Parameters

Secondary Outcome Measures

Balance

Full Information

First Posted
September 13, 2005
Last Updated
February 15, 2012
Sponsor
The University of Texas Health Science Center at San Antonio
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1. Study Identification

Unique Protocol Identification Number
NCT00223353
Brief Title
Quantitative Gait Analysis for Clinical Decision Making
Official Title
Quantitative Gait Analysis for Clinical Decision Making
Study Type
Observational

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
November 1998 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Disease, Musculoskeletal Equilibrium
Keywords
Biomechanics, Gait, Balance

7. Study Design

Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lower Limb Amputee
Arm Title
Amputee and Normals and Clinical Case Study
Arm Description
Amputee: Lower limb below/above knee amputee Normals: Health adult Clinical Case Study: Individual case studies
Intervention Type
Other
Intervention Name(s)
Prosthetics, Orthotics and Physical Therapy
Intervention Description
Gait Analysis.
Primary Outcome Measure Information:
Title
Gait Parameters
Time Frame
Not a clinical trial. Study closed to enrollment.
Secondary Outcome Measure Information:
Title
Balance
Time Frame
Not a clinical trial. Study closed to enrollment.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Study Population Description
Adults aged 18-75
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Walsh, MD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Texas Veterans Healthcare System
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Quantitative Gait Analysis for Clinical Decision Making

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