Quantitative Gait Analysis for Clinical Decision Making
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | February 15, 2012 | ||||
| Start Date ICMJE | November 1998 | ||||
| Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Gait Parameters [ Time Frame: Not a clinical trial. Study closed to enrollment. ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00223353 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Balance [ Time Frame: Not a clinical trial. Study closed to enrollment. ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Quantitative Gait Analysis for Clinical Decision Making | ||||
| Official Title ICMJE | Quantitative Gait Analysis for Clinical Decision Making | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Not Provided | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Adults aged 18-75 |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Prosthetics, Orthotics and Physical Therapy
Gait Analysis. |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 100 | ||||
| Completion Date | August 2011 | ||||
| Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00223353 | ||||
| Other Study ID Numbers ICMJE | 978-0011-149 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | The University of Texas Health Science Center at San Antonio | ||||
| Study Sponsor ICMJE | The University of Texas Health Science Center at San Antonio | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | The University of Texas Health Science Center at San Antonio | ||||
| Verification Date | February 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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