NCT03414749

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable healthy

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

July 24, 2017

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
Last Updated

February 7, 2020

Status Verified

February 1, 2020

Enrollment Period

16 days

First QC Date

January 22, 2018

Last Update Submit

February 5, 2020

Conditions

Keywords

Chiropracticpostural swaymanipulation

Outcome Measures

Primary Outcomes (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.

    Post Treatment on Day 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.

    Pre Treatment on Day 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.

    Post Treatment on Day 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.

    Pre Treatment on Day 3

Study Arms (2)

Lower Extremity First (LEF)

EXPERIMENTAL

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)

Upper Extremity First (UEF)

EXPERIMENTAL

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

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).

Lower Extremity First (LEF)

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).

Upper Extremity First (UEF)

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parker University

Dallas, Texas, 75229, United States

Location

Study Officials

  • Katherine A Pohlman, DC, MS

    Parker University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Treatment was unknown to outcome assessors. Participant were unaware of what the treatment would be and how it may / may not impact the outcome.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: This study used a randomized, crossover experimental design over three days of testing.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2018

First Posted

January 30, 2018

Study Start

July 24, 2017

Primary Completion

August 9, 2017

Study Completion

August 9, 2017

Last Updated

February 7, 2020

Record last verified: 2020-02

Locations