NCT03877367

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

July 22, 2019

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

2 days

First QC Date

March 13, 2019

Last Update Submit

September 5, 2019

Conditions

Keywords

Chiropractic manipulationExtremity manipulationBalance task

Outcome Measures

Primary Outcomes (1)

  • Head Sensor to calculate angle of head inclination

    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.

    30 seconds

Secondary Outcomes (5)

  • Ground reaction force

    less than 1 minute

  • Center of pressure

    less than 1 minute

  • Velocity to measure sway.

    less than 1 minute

  • Sway: measuring distance

    less than 1 minute

  • acceleration to measure sway

    less than 1 minute

Study Arms (2)

Upper Extremity Group, Day 1

EXPERIMENTAL

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

Lower Extremity Group, Day 2

EXPERIMENTAL

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

Interventions

An upper extremity (glenohumeral, humeroulnar and radioulnar joints, bilaterally) or a lower extremity (coxofemoral, tibiofemoral, and tibiotalar, bilaterally) manipulation series.

Also known as: Manipulation
Lower Extremity Group, Day 2Upper Extremity Group, Day 1

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parker University

Dallas, Texas, 75229, United States

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: The study will be a patient and outcome assessor blinded, cross-over randomized clinical trial. Participants will randomized into two groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2019

First Posted

March 15, 2019

Study Start

July 22, 2019

Primary Completion

July 24, 2019

Study Completion

July 24, 2019

Last Updated

September 6, 2019

Record last verified: 2019-09

Locations