Comparison of Balance Changes After Chiropractic Adjustments in Health Adults.

• ClinicalTrials.gov Identifier: NCT03877367
• Recruitment Status: Completed
• First Posted: March 15, 2019
• Last Update Posted: September 6, 2019
• Sponsor: Parker University
• Collaborators: University of Houston; Whittier University; University of Miami; Private Practice
• Information provided by (Responsible Party): Parker University

Study Description

Brief Summary:

This study will examine the effect of upper and lower extremity manipulations on an upper extremity balancing task.

Condition or disease	Intervention/treatment	Phase
Postural Balance; Musculoskeletal Manipulation	Other: Upper extremity manipulation	Not Applicable

Detailed Description:

Spinal manipulation has long been thought to have beneficial effects on posture, balance and proprioception; however, only a single study has investigated the effect of chiropractic treatment of the extremities on balance and posture. In a previous study, it was noted that lower extremity manipulation led to more ordered behavior on a dynamic, lower extremity balance task. It was also found that upper extremity manipulation led to less ordered behavior with same lower extremity balance task. Further studies are needed not only to validate this theory, but to further clarify the mechanism regarding specificity of manipulation to task.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: The study will be a patient and outcome assessor blinded, cross-over randomized clinical trial. Participants will randomized into two groups.
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Immediate Impact of Extremity Manipulation on an Upper Extremity (UE) Balancing Task
• Actual Study Start Date: July 22, 2019
• Actual Primary Completion Date: July 24, 2019
• Actual Study Completion Date: July 24, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Upper Extremity Group, Day 1; Day 1: This group will receive a pre-test, upper extremity intervention, and post-test. Day 2: This group will receive a pre-test, lower extremity intervention, and post-test.	Other: Upper extremity manipulation; An upper extremity (glenohumeral, humeroulnar and radioulnar joints, bilaterally) or a lower extremity (coxofemoral, tibiofemoral, and tibiotalar, bilaterally) manipulation series.; Other Name: Manipulation
Experimental: Lower Extremity Group, Day 2; Day 1: This group will receive a pre-test, lower extremity intervention, and post-test. Day 2: This group will receive a pre-test, upper extremity intervention, and post-test.	Other: Upper extremity manipulation; An upper extremity (glenohumeral, humeroulnar and radioulnar joints, bilaterally) or a lower extremity (coxofemoral, tibiofemoral, and tibiotalar, bilaterally) manipulation series.; Other Name: Manipulation

Outcome Measures

Primary Outcome Measures :

1. Head Sensor to calculate angle of head inclination [ Time Frame: 30 seconds ]
   There will be a sensor placed on each participant's head (in a neoprene headband), as well as on the midpoint of the tube. The head sensor will be used to calculate the angle of head inclination. The sensor on the tube will be used to calculate Sample Entropy as well as general kinematics.

Secondary Outcome Measures :

1. Ground reaction force [ Time Frame: less than 1 minute ]
   Participants will be standing on a force plate that will characterize their ground reaction forces, eyes open without tube (EONT) versus eyes closed without the tube (ECNT).
2. Center of pressure [ Time Frame: less than 1 minute ]
   Participants will be standing on a force plate that will characterize their center of pressure, EONT versus eye open with the tube horizontally (EOWT).
3. Velocity to measure sway. [ Time Frame: less than 1 minute ]
   Participants will be standing on a force plate that will characterize their velocity of sway, EOWT versus eye closed with tube held horizontally (ECWT).
4. Sway: measuring distance [ Time Frame: less than 1 minute ]
   Participants will be standing on a force plate that will characterize their distance of sway, EOWT versus ECWT.
5. acceleration to measure sway [ Time Frame: less than 1 minute ]
   Participants will be standing on a force plate that will characterize their acceleration of sway, EOWT versus ECWT.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Between the age 18 years old and 35 years old
• Cleared to be treated in Parker Wellness Clinic

Exclusion Criteria:

• Hx of neurological disorders
• Hx of musculoskeletal disorders/injuries that could impact his/her ability to stand upright
• Currently known to be pregnant
• Compromised vision (beyond the wearing of corrective lenses)

Contacts and Locations

Locations

United States, Texas

Parker University

Dallas, Texas, United States, 75229

Sponsors and Collaborators

Parker University

University of Houston

Whittier University

University of Miami

Private Practice

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Malaya CA, Haworth J, Pohlman KA, Smith DL. Immediate impact of extremity manipulation on dual task performance: a randomized, crossover clinical trial. Chiropr Man Therap. 2021 Feb 5;29(1):6. doi: 10.1186/s12998-021-00366-5.

• Responsible Party: Parker University
• ClinicalTrials.gov Identifier: NCT03877367
• Other Study ID Numbers: Parker19_03
• First Posted: March 15, 2019
• Last Update Posted: September 6, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

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

Keywords provided by Parker University:

Chiropractic manipulation; Extremity manipulation; Balance task