Acute Responses of Postural Alignment, Kinematic Synergy, and Intermuscular Coherence to Postural Muscle Facilitation

November 2, 2022 updated by: Stephen Glass, Radford University
Clinicians frequently assess and intervene on postural alignment. However, research demonstrating the effects of exercise interventions in moving postural alignment toward an evidence-based standard is lacking. Part of the difficulty in establishing such evidence has been a lack of theory-motivated conceptions of what "good" posture is. In other words, the prevailing understanding of postural alignment is based on the negation of what has been observed to associate with bad outcomes. This study will build upon preliminary findings from our laboratory that define good postural alignment on theoretical grounds. The investigators will measure motion capture and muscle activation patterns during simple postural alignment tasks before and after 1) a corrective exercise intervention, or 2) a control intervention based designed to inhibit superficial muscle tension. The corrective exercise intervention is designed to counteract the natural patterns in which the human skeleton tends to collapse from a standing position under the influence of gravity. The control intervention consists of passive, partner-assisted stretching. Regardless of initial assignment, all participants will crossover (i.e. switch interventions) and repeat the study procedures after a 1-week washout period. Behavioral indicators of movement and nervous system coordination will be used to quantify alignment before and after exercise, as well as the consistency of those alignment patterns with theoretically-defined standards. The knowledge gained from this study will contribute to evidence-based definitions of healthy postural alignment and help identify effective interventions by which clinicians can promote good posture.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Virginia
      • Roanoke, Virginia, United States, 24013
        • Recruiting
        • Radford University Carilion
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adult
  • 18 - 40 years of age

Exclusion Criteria:

  • Recent (< 6 months) history of lower extremity injury
  • Recent (< 6 months) history of other musculoskeletal or neurological disorder affecting balance
  • Contraindications to participation in physical activity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Exercise Then Stretch
Participants in AB will perform the experimental (exercise) intervention first and the control (stretch) intervention second
Other: Exercise Then Stretch
This arm (sequence) will perform an anti-gravity kinetic chain intervention and then a passive, partner-assisted stretching intervention, separated by a one-week washout period.
Other: Stretch Then Exercise
This arm (sequence) will perform a passive, partner-assisted stretching intervention and then an anti-gravity kinetic chain intervention , separated by a one-week washout period.
OTHER: Stretch Then Exercise
Participants in BA will perform the experimental (exercise) intervention second and the control (stretch) intervention first
Other: Exercise Then Stretch
This arm (sequence) will perform an anti-gravity kinetic chain intervention and then a passive, partner-assisted stretching intervention, separated by a one-week washout period.
Other: Stretch Then Exercise
This arm (sequence) will perform a passive, partner-assisted stretching intervention and then an anti-gravity kinetic chain intervention , separated by a one-week washout period.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Euclidean distance from the vector describing subject-specific, simulated gravitational collapse
Time Frame: Immediately before Intervention (Day 1)
This outcome is a cumulative descriptor of segment angle distance from the pattern in which an individual's posture would collapse. The reference point for each individual is calculated using both pre and post-intervention data for a given day.
Immediately before Intervention (Day 1)
Euclidean distance from the vector describing subject-specific, simulated gravitational collapse
Time Frame: Immediately after Intervention (Day 1)
This outcome is a cumulative descriptor of segment angle distance from the pattern in which an individual's posture would collapse. The reference point for each individual is calculated using both pre and post-intervention data for a given day.
Immediately after Intervention (Day 1)
Euclidean distance from the vector describing subject-specific, simulated gravitational collapse
Time Frame: Immediately before Intervention (Day 7)
This outcome is a cumulative descriptor of segment angle distance from the pattern in which an individual's posture would collapse. The reference point for each individual is calculated using both pre and post-intervention data for a given day.
Immediately before Intervention (Day 7)
Euclidean distance from the vector describing subject-specific, simulated gravitational collapse
Time Frame: Immediately after Intervention (Day 7)
This outcome is a cumulative descriptor of segment angle distance from the pattern in which an individual's posture would collapse. The reference point for each individual is calculated using both pre and post-intervention data for a given day.
Immediately after Intervention (Day 7)
Pooled intermuscular coherence
Time Frame: Immediately before Intervention (Day 1)
Weighted average of frequency-domain correlations between muscle pairs belonging to anterior, posterior, and trunk muscle groups.
Immediately before Intervention (Day 1)
Pooled intermuscular coherence
Time Frame: Immediately after Intervention (Day 1)
Weighted average of frequency-domain correlations between muscle pairs belonging to anterior, posterior, and trunk muscle groups.
Immediately after Intervention (Day 1)
Pooled intermuscular coherence
Time Frame: Immediately before Intervention (Day 7)
Weighted average of frequency-domain correlations between muscle pairs belonging to anterior, posterior, and trunk muscle groups.
Immediately before Intervention (Day 7)
Pooled intermuscular coherence
Time Frame: Immediately after Intervention (Day 7)
Weighted average of frequency-domain correlations between muscle pairs belonging to anterior, posterior, and trunk muscle groups.
Immediately after Intervention (Day 7)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Top-down kinetic chain continuity
Time Frame: Immediately before Intervention (Day 1)
The purpose of this outcome is to quantify the communication of motion from the upper body to the lower body. In a test involving placing hands-on-head and pulling the elbows back as far as possible, the response in the lower body is quantified by posterior rotation of the tibial segment.
Immediately before Intervention (Day 1)
Top-down kinetic chain continuity
Time Frame: Immediately after Intervention (Day 1)
The purpose of this outcome is to quantify the communication of motion from the upper body to the lower body. In a test involving placing hands-on-head and pulling the elbows back as far as possible, the response in the lower body is quantified by posterior rotation of the tibial segment.
Immediately after Intervention (Day 1)
Top-down kinetic chain continuity
Time Frame: Immediately before Intervention (Day 7)
The purpose of this outcome is to quantify the communication of motion from the upper body to the lower body. In a test involving placing hands-on-head and pulling the elbows back as far as possible, the response in the lower body is quantified by posterior rotation of the tibial segment.
Immediately before Intervention (Day 7)
Top-down kinetic chain continuity
Time Frame: Immediately after Intervention (Day 7)
The purpose of this outcome is to quantify the communication of motion from the upper body to the lower body. In a test involving placing hands-on-head and pulling the elbows back as far as possible, the response in the lower body is quantified by posterior rotation of the tibial segment.
Immediately after Intervention (Day 7)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Radford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-288-RUC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified raw data for individual participants will be shared upon request with parties committing to institutional data sharing agreements.

IPD Sharing Time Frame

On request and indefinitely.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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