NCT05608850

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

October 28, 2022

Last Update Submit

November 2, 2022

Conditions

Keywords

AlignmentPostureMotor controlIntervention

Outcome Measures

Primary Outcomes (8)

  • Euclidean distance from the vector describing subject-specific, simulated gravitational collapse

    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

    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

    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

    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

    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

    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

    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

    Weighted average of frequency-domain correlations between muscle pairs belonging to anterior, posterior, and trunk muscle groups.

    Immediately after Intervention (Day 7)

Secondary Outcomes (4)

  • Top-down kinetic chain continuity

    Immediately before Intervention (Day 1)

  • Top-down kinetic chain continuity

    Immediately after Intervention (Day 1)

  • Top-down kinetic chain continuity

    Immediately before Intervention (Day 7)

  • Top-down kinetic chain continuity

    Immediately after Intervention (Day 7)

Study Arms (2)

Exercise Then Stretch

OTHER

Participants in AB will perform the experimental (exercise) intervention first and the control (stretch) intervention second

Other: Exercise Then StretchOther: Stretch Then Exercise

Stretch Then Exercise

OTHER

Participants in BA will perform the experimental (exercise) intervention second and the control (stretch) intervention first

Other: Exercise Then StretchOther: Stretch Then Exercise

Interventions

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.

Exercise Then StretchStretch 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.

Exercise Then StretchStretch Then Exercise

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult
  • years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radford University Carilion

Roanoke, Virginia, 24013, United States

RECRUITING

Central Study Contacts

Stephen M Glass, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 28, 2022

First Posted

November 8, 2022

Study Start

October 25, 2022

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

November 8, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
On request and indefinitely.

Locations