The Ability of Osteopathic Structural Evaluation to Assess Gait

• ClinicalTrials.gov Identifier: NCT04860999
• Recruitment Status: Completed
• First Posted: April 27, 2021
• Last Update Posted: April 27, 2021
• Sponsor: Edward Via Virginia College of Osteopathic Medicine
• Information provided by (Responsible Party): Edward Via Virginia College of Osteopathic Medicine

Study Description

Brief Summary:

Movement and loading asymmetry have been associated with injury risk for a variety of both acute and chronic musculoskeletal injuries. In addition, asymmetric movements have been identified as compensatory strategies to allow for ambulation in a variety of post-operative populations. Osteopathic physicians have been assessing both structure and function through the use of structural evaluation techniques along with postural assessment that can identify somatic dysfunction. However, no studies have identified the ability of an osteopathic structural evaluation and postural assessment to identify potential movement disorders and loading asymmetry. Therefore, the primary objective of this study is to determine the acute impact of an osteopathic manipulation on restoration of side-to-side symmetry during walking gait in participants who are categorized as having lower extremity dysfunction. We enrolled 51 participants who are pain-free and without a history of major orthopaedic injuries that required surgical intervention. Each subject completed an osteopathic structural evaluation and postural assessment along with an osteopathic manipulation. All participants completed instrumented gait analyses before and after the osteopathic manipulation using a motion capture system and an instrumented treadmill to determine the participant's movement and loading asymmetry during walking.

Condition or disease	Intervention/treatment	Phase
Osteopathic Manipulation; Postural; Defect; Somatic; Functional Disturbance	Procedure: Osteopathic Manipulative Treatment	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 51 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Participants underwent an osteopathic structural examination and osteopathic manipulation. Participants completed a biomechanical assessment prior to and following the osteopathic manipulation to evaluate the effect of osteopathic manipulation on gait asymmetry.
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: The Ability of Osteopathic Structural Evaluation to Assess Gait
• Actual Study Start Date: August 15, 2017
• Actual Primary Completion Date: December 20, 2017
• Actual Study Completion Date: December 20, 2017

Arms and Interventions

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.

Procedure: Osteopathic Manipulative Treatment; 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.

Outcome Measures

Primary Outcome Measures :

1. 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) ]
2. 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) ]

Secondary Outcome Measures :

1. 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) ]
2. Peak knee flexion angle asymmetry between limbs [ Time Frame: Before an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5-10 minutes before) ]
3. Step length asymmetry between limbs [ Time Frame: Before an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5-10 minutes before) ]
4. Stride length asymmetry between limbs [ Time Frame: Before an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5-10 minutes before) ]
5. Stance time asymmetry between limbs [ Time Frame: Before an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5-10 minutes before) ]
6. Peak vertical ground reaction force impulse asymmetry between limbs [ Time Frame: After an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5 minutes after) ]
7. Peak knee flexion angle asymmetry between limbs [ Time Frame: After an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5 minutes after) ]
8. Step length asymmetry between limbs [ Time Frame: After an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5 minutes after) ]
9. Stride length asymmetry between limbs [ Time Frame: After an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5 minutes after) ]
10. Stance time asymmetry between limbs [ Time Frame: After an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5 minutes after) ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Virginia

Virginia Polytechnic Institute and State University

Blacksburg, Virginia, United States, 24061

Sponsors and Collaborators

Edward Via Virginia College of Osteopathic Medicine

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

More Information

• Responsible Party: Edward Via Virginia College of Osteopathic Medicine
• ClinicalTrials.gov Identifier: NCT04860999
• Other Study ID Numbers: 2016-051
• First Posted: April 27, 2021
• Last Update Posted: April 27, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Edward Via Virginia College of Osteopathic Medicine:

gait; assessment; manipulation; asymmetry; osteopathic