ClinicalTrials.gg
CompletedNCT03414749Balance1Updated Feb 7, 2020

Extremity Manipulation Impact on Postural Sway Characteristics

An interventional study of Lower Extremity First (LEF) and Upper Extremity First (UEF) in Healthy, sponsored by Parker University. Completed at 1 site in United States. Open to participants aged 21 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-07.

Sponsored by Parker University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jul 2017, registered Jan 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
21 Years to 40 Years
Sex
All
01

Study summary

This study will evaluate the multi-segmental postural sway after upper versus lower extremity manipulation.

Read the detailed description

The focus of this study is to explore the effect of upper and lower extremity chiropractic adjustments (manipulation) as well as surface condition (hard surface vs rocker board) on multisegmental postural control as represented by postural sway. Using a rocker (tilt) board, the participant cannot stand still, but has to adjust posture continuously to maintain balance. Body sways are considered to be self-induced because the design of the rocker board creates a natural instability without any external perturbation. This task provides a self-driven sensorimotor condition in addition to amplifying the sway dynamics. Because the rocker board has only one degree of freedom of motion, anteroposterior and lateral sways were considered separately on the device.

The investigators had the following hypotheses.

Hypothesis 1: Lower extremity adjustments will lead to reduced postural sway magnitude compared to upper extremity adjustments.

Hypothesis 2: Lower extremity adjustments will reduce sway variability of the rocker board, trunk and head compared to upper extremity adjustments.

Hypothesis 3: Lower extremity adjustments will facilitate the organization of sway behavior as assessed by the chaotic structure of sway.

02

Conditions studied

  • Healthy

Keywords

  • Chiropractic
  • postural sway
  • manipulation
03

In context

Lead sponsor

Parker University is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • student in Parker University's Doctor of Chiropractic program and patient at the Parker University Wellness Clinic;
  • available to take part in the study for all 3 test days;
  • willing to forgo all non-normal daily activities and chiropractic treatments during the test days;

Exclusion criteria

Exclusion Criteria:

  • pregnant;
  • previous major injury involving the extremities;
  • previous surgeries to an extremity joint; and
  • known neurological or systemic diseases.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Lower Extremity First (LEF)

    The treatment was a non-specific long-axis distraction to the ankle, knee, and hip provided was at the discretion of the clinic doctor (over 25 years experience).

    Procedure: Lower Extremity First (LEF)

  • Experimental
    Upper Extremity First (UEF)

    The treatment was a non-specific long-axis distraction to the shoulder, elbow and wrist provided was at the discretion of the clinic doctor (over 25 years experience).

    Procedure: Upper Extremity First (UEF)

Interventions

  • ProcedureLower Extremity First (LEF)

    The intervention for the LEF group was a non-specific long-axis distraction to the ankle, knee, and hip or shoulder, elbow and wrist provided was at the discretion of the clinic doctor (over 25 years experience).

  • ProcedureUpper Extremity First (UEF)

    The intervention for the UEF group was a non-specific long-axis distraction to the shoulder, elbow and wrist provided was at the discretion of the clinic doctor (over 25 years experience).

06

What researchers measure

Primary outcomes

  1. Postural Assessment

    Each participant was fitted with two Shimmer3 sensors (Shimmer Sensing, Dublin, Ireland) on their head (occiput) and low back (over S2 tubercle) (see Figure 2) with a third Shimmer3 sensor placed on the surface (ground or rocker board). Participants were asked to perform a series of four postural tasks with two surface conditions (floor or rocker board) and two variations of each (eyes open or closed, and AP or ML rocker board direction). The conditions were randomized (using REDCap) such that either both floor or both rocker board conditions were performed first, with the remainder performed second. The order of variation within the surface type was held consistent for all occasions; eyes open then eyes closed on the floor, and AP then ML rotation direction on the rocker board.

    Time frame: Post Treatment on Day 1

  2. Postural Assessment

    Each participant was fitted with two Shimmer3 sensors (Shimmer Sensing, Dublin, Ireland) on their head (occiput) and low back (over S2 tubercle) (see Figure 2) with a third Shimmer3 sensor placed on the surface (ground or rocker board). Participants were asked to perform a series of four postural tasks with two surface conditions (floor or rocker board) and two variations of each (eyes open or closed, and AP or ML rocker board direction). The conditions were randomized (using REDCap) such that either both floor or both rocker board conditions were performed first, with the remainder performed second. The order of variation within the surface type was held consistent for all occasions; eyes open then eyes closed on the floor, and AP then ML rotation direction on the rocker board.

    Time frame: Pre Treatment on Day 2

  3. Postural Assessment

    Each participant was fitted with two Shimmer3 sensors (Shimmer Sensing, Dublin, Ireland) on their head (occiput) and low back (over S2 tubercle) (see Figure 2) with a third Shimmer3 sensor placed on the surface (ground or rocker board). Participants were asked to perform a series of four postural tasks with two surface conditions (floor or rocker board) and two variations of each (eyes open or closed, and AP or ML rocker board direction). The conditions were randomized (using REDCap) such that either both floor or both rocker board conditions were performed first, with the remainder performed second. The order of variation within the surface type was held consistent for all occasions; eyes open then eyes closed on the floor, and AP then ML rotation direction on the rocker board.

    Time frame: Post Treatment on Day 2

  4. Postural Assessment

    Each participant was fitted with two Shimmer3 sensors (Shimmer Sensing, Dublin, Ireland) on their head (occiput) and low back (over S2 tubercle) (see Figure 2) with a third Shimmer3 sensor placed on the surface (ground or rocker board). Participants were asked to perform a series of four postural tasks with two surface conditions (floor or rocker board) and two variations of each (eyes open or closed, and AP or ML rocker board direction). The conditions were randomized (using REDCap) such that either both floor or both rocker board conditions were performed first, with the remainder performed second. The order of variation within the surface type was held consistent for all occasions; eyes open then eyes closed on the floor, and AP then ML rotation direction on the rocker board.

    Time frame: Pre Treatment on Day 3

07

Study locations

1 site
  • Parker University
    Dallas, Texas 75229, United States
08

References and documents

Individual participant data

Plan to share: Undecided — It is not yet known if there will be a plan to make IPD available.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2017 to primary completion in Aug 2017, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 22, 2018
First posted
Jan 30, 2018
StartActual
Jul 24, 2017
Primary completionActual
Aug 9, 2017
CompletionActual
Aug 9, 2017
Last update
Feb 7, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03414749
Lead sponsor
Parker University
Collaborators
University of Miami, Whittier University, University of Houston
Responsible party
Sponsor
First posted
Jan 30, 2018
Start date
Jul 24, 2017
Primary completion
Aug 9, 2017
Completion
Aug 9, 2017
Last update
Feb 7, 2020

Study contacts

Katherine A Pohlman, DC, MS
study director · Parker University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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