Joint DiseaseNCT00223353
Quantitative Gait Analysis for Clinical Decision Making
An observational study of Joint Disease and Musculoskeletal Equilibrium, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Joint Disease, Musculoskeletal Equilibrium
- What is being tested?
- Prosthetics, Orthotics and Physical Therapy
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1998to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adults aged 18-75
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
South Texas Veterans Healthcare System
San Antonio, Texas, 78229
About this study
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.
Read the 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.
- Conditions
- Joint Disease, Musculoskeletal Equilibrium
- Being tested
- Prosthetics, Orthotics and Physical Therapy
- Keywords
- Biomechanics, Gait, Balance
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthetics, Orthotics and Physical TherapyOther
Gait Analysis.
| Study group | Role | What they receive |
|---|---|---|
| Lower Limb Amputee | Not described Receives: Other: Prosthetics, Orthotics and Physical Therapy | |
| Amputee and Normals and Clinical Case Study | Amputee:
Lower limb below/above knee amputee
Normals:
Health adult
Clinical Case Study:
Individual case studies Receives: Other: Prosthetics, Orthotics and Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Parameters
Measured: Not a clinical trial. Study closed to enrollment.
Secondary outcomes (1)
Balance
Measured: Not a clinical trial. Study closed to enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 1998
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Walsh, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223353
- Sponsor's protocol ID
- 978-0011-149
- Status last verified
- Feb 2012
- First submitted
- 13 Sep 2005
- Last updated
- 17 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Gait Analysis for Clinical Decision Making
- ClinicalTrials.gov ID
- NCT00223353
- Acronym / sponsor ID
- 978-0011-149
- Conditions
- Joint Disease, Musculoskeletal Equilibrium
- Keywords
- Biomechanics, Gait, Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Nov 1998
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower Limb Amputee | – | Other: Prosthetics, Orthotics and Physical Therapy |
| Amputee and Normals and Clinical Case Study | – | Other: Prosthetics, Orthotics and Physical TherapyAmputee: Lower limb below/above knee amputee Normals: Health adult Clinical Case Study: Individual case studies |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults aged 18-75
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prosthetics, Orthotics and Physical TherapyGait Analysis. | Other | Amputee and Normals and Clinical Case Study, Lower Limb Amputee |
Primary outcome
Gait Parameters
Time frame: Not a clinical trial. Study closed to enrollment.
1 secondary outcome
Balance
Time frame: Not a clinical trial. Study closed to enrollment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Walsh, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Joint Disease and Musculoskeletal Equilibrium, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Parameters (time frame: Not a clinical trial. Study closed to enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2012.