Osteopathic ManipulationNCT04860999
The Ability of Osteopathic Structural Evaluation to Assess Gait
A study testing Osteopathic Manipulative Treatment in people with Osteopathic Manipulation and Postural; Defect, run by Edward Via Virginia College of Osteopathic Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteopathic Manipulation, Postural; Defect, Somatic; Functional Disturbance
- What is being tested?
- Osteopathic Manipulative Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2017to 20 Dec 2017
- Phase
- Interventional
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between ages of 18 and 35
Who cannot join
- History of major lower extremity surgery
- Currently being under the care of a medical professional for any musculoskeletal injury or chronic condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Polytechnic Institute and State University
Blacksburg, Virginia, 24061
About this study
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.
Read the 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.
- Being tested
- Osteopathic Manipulative Treatment
- Keywords
- gait, assessment, manipulation, asymmetry, osteopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TreatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Osteopathic Manipulative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak vertical ground reaction force asymmetry between limbs during the weight acceptance and propulsive phases of walking
Measured: 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
Measured: 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
Measured: Before an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5-10 minutes before)
Peak knee flexion angle asymmetry between limbs
Measured: Before an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5-10 minutes before)
Step length asymmetry between limbs
Measured: Before an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5-10 minutes before)
Stride length asymmetry between limbs
Measured: Before an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5-10 minutes before)
Stance time asymmetry between limbs
Measured: Before an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5-10 minutes before)
Peak vertical ground reaction force impulse asymmetry between limbs
Measured: After an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5 minutes after)
Peak knee flexion angle asymmetry between limbs
Measured: After an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5 minutes after)
Step length asymmetry between limbs
Measured: After an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5 minutes after)
Stride length asymmetry between limbs
Measured: After an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5 minutes after)
Stance time asymmetry between limbs
Measured: After an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5 minutes after)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start15 Aug 2017
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteopathic ManipulationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward Via Virginia College of Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robin Queen, Principal investigator, Virginia Polytechnic Institute and State UniversityGunnar Brolinson, Principal investigator, Edward Via College of Osteopathic MedicineMark Rogers, Principal investigator, Edward Via College of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860999
- Sponsor's protocol ID
- 2016-051
- Status last verified
- Apr 2021
- First submitted
- 24 Mar 2021
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ability of Osteopathic Structural Evaluation to Assess Gait
- ClinicalTrials.gov ID
- NCT04860999
- Acronym / sponsor ID
- 2016-051
- Keywords
- gait, assessment, manipulation, asymmetry, osteopathic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Edward Via Virginia College of Osteopathic MedicineUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 27 Apr 2021 (actual)
- 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.
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.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Somatic Dysfunction | Experimental | Procedure: Osteopathic Manipulative TreatmentThis 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Between ages of 18 and 35
Key exclusion criteria (2 listed)
- History of major lower extremity surgery
- Currently being under the care of a medical professional for any musculoskeletal injury or chronic condition
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 |
|---|---|---|
| Osteopathic Manipulative TreatmentThe 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. | Procedure or surgery | Somatic Dysfunction |
Primary outcome
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)
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)
10 secondary outcomes
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)
Peak knee flexion angle asymmetry between limbs
Time frame: 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)
Stride length asymmetry between limbs
Time frame: 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)
Peak vertical ground reaction force impulse asymmetry between limbs
Time frame: 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)
Step length asymmetry between limbs
Time frame: 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)
Stance time asymmetry between limbs
Time frame: After an osteopathic manipulative treatment addressing identified somatic dysfunctions (approximately 5 minutes after)
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 27 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Robin Queen principal investigator
Virginia Polytechnic Institute and State University
Gunnar Brolinson principal investigator
Edward Via College of Osteopathic Medicine
Mark Rogers principal investigator
Edward Via College of Osteopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment in people with Osteopathic Manipulation and Postural; Defect, run by Edward Via Virginia College of Osteopathic Medicine 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 27 Apr 2021. 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?
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)). The study lists 2 primary outcomes in all. 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 27 Apr 2021.