Extremity Manipulation Impact on Postural Sway Characteristics (Balance1)

• ClinicalTrials.gov Identifier: NCT03414749
• Recruitment Status: Completed
• First Posted: January 30, 2018
• Last Update Posted: February 7, 2020
• Sponsor: Parker University
• Collaborators: University of Miami; Whittier University; University of Houston
• Information provided by (Responsible Party): Parker University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Healthy	Procedure: Lower Extremity First (LEF); Procedure: Upper Extremity First (UEF)	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: This study used a randomized, crossover experimental design over three days of testing.
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Treatment was unknown to outcome assessors. Participant were unaware of what the treatment would be and how it may / may not impact the outcome.
• Primary Purpose: Treatment
• Official Title: Assessment of Balance Changes After Extremity Manipulation Therapy
• Actual Study Start Date: July 24, 2017
• Actual Primary Completion Date: August 9, 2017
• Actual Study Completion Date: August 9, 2017

Arms and Interventions

Arm	Intervention/treatment
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); 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).
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); 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).

Outcome Measures

Primary Outcome Measures :

1. Postural Assessment [ Time Frame: Post Treatment on Day 1 ]
   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.
2. Postural Assessment [ Time Frame: Pre Treatment on Day 2 ]
   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.
3. Postural Assessment [ Time Frame: Post Treatment on Day 2 ]
   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.
4. Postural Assessment [ Time Frame: Pre Treatment on Day 3 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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:

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

Contacts and Locations

Locations

United States, Texas

Parker University

Dallas, Texas, United States, 75229

Sponsors and Collaborators

Parker University

University of Miami

Whittier University

University of Houston

Investigators

• Study Director: Katherine A Pohlman, DC, MS; Parker University

More Information

• Responsible Party: Parker University
• ClinicalTrials.gov Identifier: NCT03414749
• Other Study ID Numbers: Parker17_001
• First Posted: January 30, 2018
• Last Update Posted: February 7, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: It is not yet known if there will be a plan to make IPD available.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Parker University:

Chiropractic; postural sway; manipulation