- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04860999
The Ability of Osteopathic Structural Evaluation to Assess Gait
Study Overview
Status
Intervention / Treatment
Detailed Description
Following recruitment and the completion of informed consent, each subject had a standard osteopathic postural assessment. This assessment was completed by a single experienced osteopathic physicians who uses manual medicine techniques in clinical practice as well as teaching these techniques to osteopathic medical students.
Following the osteopathic exam, all participants completed an initial biomechanical assessment in the Kevin P. Granata Biomechanics Lab at Virginia Tech. All subjects wore form fitting shorts and a shirt, plus a pair of athletic shoes (Nike Pegasus, Nike Inc, Beaverton, CO) all of which was provided for them to use during testing. Patients had retro-reflective markers attached at specific locations on both lower extremities to track segmental motion level walking. Three-dimensional coordinate data was collected using a 8-camera motion capture system at a sampling rate of 120 Hz (Qualysis, Sweden). Ground reaction forces were collected using an instrumented treadmill with a sampling rate of 1440 Hz (AMTI, Watertown, Massachusetts). Each subject completed a standing trial followed by 2 walking trials. Participants completed 5 minutes of continuous steady state walking at 1.5m/s on the instrumented treadmill. Participants then completed a second 5 minute walking trial at their self-selected speed on the instrumented treadmill. During both 5 minute walking trials, data was collected simultaneously from the motion capture system and the instrumented treadmill from minute 1 through minute 4 in order to avoid collection during the beginning and end of the trial.
After the initial biomechanical examination, osteopathic manipulation was performed on participants in the Dysfunction group. The osteopathic manipulations were focused on treating the asymmetric postural dysfunction that was identified by the initial functional structural evaluation. The manipulation consisted of typical time-honored osteopathic treatments directed at the identified somatic dysfunction(s). These techniques were clinically directed and include: soft tissue, muscle energy, high velocity low amplitude, low velocity high amplitude as well as facilitated positional release as indicated.
After the osteopathic manipulation, participants completed the same walking assessment for a second time. This immediate post-biofeedback testing was completed using the same protocol as the baseline assessment previously described.
All osteopathic assessments and manipulations were completed by a single experienced osteopathic clinicians and the biomechanical assessments was completed by a second individual using a standard set of directions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
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Blacksburg, Virginia, United States, 24061
- Virginia Polytechnic Institute and State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Between ages of 18 and 35
Exclusion Criteria:
- History of major lower extremity surgery
- Currently being under the care of a medical professional for any musculoskeletal injury or chronic condition
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Somatic Dysfunction
This is the single study arm.
All participants completed an osteopathic postural examination and an osteopathic manipulative treatment.
Participants also completed a biomechanical assessment prior to and following the osteopathic manipulative treatment to evaluate effects of the treatment on the gait asymmetry.
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The osteopathic manipulations focused on treating the asymmetric postural dysfunction that was identified by the initial functional structural evaluation.
The manipulation consisted of typical time-honored osteopathic treatments directed at the identified somatic dysfunction(s).
These techniques were clinically directed and include: soft tissue, muscle energy, high velocity low amplitude, low velocity high amplitude as well as facilitated positional release as indicated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Peak vertical ground reaction force asymmetry between limbs during the weight acceptance and propulsive phases of walking
Time Frame: Before an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5-10 minutes before)
|
Before an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5-10 minutes before)
|
Peak vertical ground reaction force asymmetry between limbs during the weight acceptance and propulsive phases of walking
Time Frame: After an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5 minutes after)
|
After an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5 minutes after)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Peak vertical ground reaction force impulse asymmetry between limbs
Time Frame: Before an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5-10 minutes before)
|
Before an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5-10 minutes before)
|
Peak knee flexion angle asymmetry between limbs
Time Frame: Before an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5-10 minutes before)
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Before an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5-10 minutes before)
|
Step length asymmetry between limbs
Time Frame: Before an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5-10 minutes before)
|
Before an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5-10 minutes before)
|
Stride length asymmetry between limbs
Time Frame: Before an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5-10 minutes before)
|
Before an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5-10 minutes before)
|
Stance time asymmetry between limbs
Time Frame: Before an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5-10 minutes before)
|
Before an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5-10 minutes before)
|
Peak vertical ground reaction force impulse asymmetry between limbs
Time Frame: After an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5 minutes after)
|
After an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5 minutes after)
|
Peak knee flexion angle asymmetry between limbs
Time Frame: After an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5 minutes after)
|
After an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5 minutes after)
|
Step length asymmetry between limbs
Time Frame: After an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5 minutes after)
|
After an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5 minutes after)
|
Stride length asymmetry between limbs
Time Frame: After an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5 minutes after)
|
After an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5 minutes after)
|
Stance time asymmetry between limbs
Time Frame: After an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5 minutes after)
|
After an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5 minutes after)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Robin Queen, Virginia Polytechnic Institute and State University
- Principal Investigator: Gunnar Brolinson, Edward Via College of Osteopathic Medicine
- Principal Investigator: Mark Rogers, Edward Via College of Osteopathic Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2016-051
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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