NCT04860999

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 27, 2021

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

4 months

First QC Date

March 24, 2021

Last Update Submit

April 22, 2021

Conditions

Keywords

gaitassessmentmanipulationasymmetryosteopathic

Outcome Measures

Primary Outcomes (2)

  • Peak vertical ground reaction force asymmetry between limbs during the weight acceptance and propulsive phases of walking

    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

    After an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5 minutes after)

Secondary Outcomes (10)

  • Peak vertical ground reaction force impulse asymmetry between limbs

    Before an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5-10 minutes before)

  • Peak knee flexion angle asymmetry between limbs

    Before an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5-10 minutes before)

  • Step length asymmetry between limbs

    Before an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5-10 minutes before)

  • Stride length asymmetry between limbs

    Before an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5-10 minutes before)

  • Stance time asymmetry between limbs

    Before an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5-10 minutes before)

  • +5 more secondary outcomes

Study Arms (1)

Somatic Dysfunction

EXPERIMENTAL

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

Interventions

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.

Somatic Dysfunction

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between ages of 18 and 35

You may not qualify if:

  • History of major lower extremity surgery
  • Currently being under the care of a medical professional for any musculoskeletal injury or chronic condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Polytechnic Institute and State University

Blacksburg, Virginia, 24061, United States

Location

MeSH Terms

Interventions

Manipulation, Osteopathic

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2021

First Posted

April 27, 2021

Study Start

August 15, 2017

Primary Completion

December 20, 2017

Study Completion

December 20, 2017

Last Updated

April 27, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations