Effect of Lower Extremity Joint Manipulation on a Lower Extremity Somatosensory Illusion
Primary Purpose
Coordination and Balance Disturbances, Healthy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
chiropractic manual therapy
Sponsored by
About this trial
This is an interventional basic science trial for Coordination and Balance Disturbances
Eligibility Criteria
Inclusion Criteria:
- No previous surgeries
- Not knowingly pregnant
- No neuromusculoskeletal injuries or systemic diseases that could affect an individual's ability to stand on an incline for 3 minutes with their eyes closed.
Exclusion Criteria:
- Weight over the force plate operating limit of 440 lbs
Sites / Locations
- Synapse Laboratory
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Received a bilateral, lower extremity manipulation series
30 seconds of lying supine on a chiropractic bench (control) without manual manipulation
Outcomes
Primary Outcome Measures
Center of pressure position
position in centimeters as evaluated by a force plate
Secondary Outcome Measures
Pathlength
cumulative distance traveled by center of pressure during trial
RMS
(Root mean square) measure of amplitude of center of pressure during trial
Mean velocity
average speed and direction of center of pressure during trial
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05226715
Brief Title
Effect of Lower Extremity Joint Manipulation on a Lower Extremity Somatosensory Illusion
Official Title
Immediate Effect of Lower Extremity Joint Manipulation on a Lower Extremity Somatosensory Illusion: a Preliminary, Randomized, Controlled Crossover Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 14, 2021 (Actual)
Primary Completion Date
May 16, 2021 (Actual)
Study Completion Date
May 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Parker University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to examine the influence of extremity manipulation on individual's center of pressure after they adapt to an ankle based illusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coordination and Balance Disturbances, Healthy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Received a bilateral, lower extremity manipulation series
Arm Title
Control
Arm Type
No Intervention
Arm Description
30 seconds of lying supine on a chiropractic bench (control) without manual manipulation
Intervention Type
Other
Intervention Name(s)
chiropractic manual therapy
Intervention Description
high velocity low amplitude thrust into a human joint
Primary Outcome Measure Information:
Title
Center of pressure position
Description
position in centimeters as evaluated by a force plate
Time Frame
baseline, immediately post-intervention, same day
Secondary Outcome Measure Information:
Title
Pathlength
Description
cumulative distance traveled by center of pressure during trial
Time Frame
baseline, immediately post-intervention, same day
Title
RMS
Description
(Root mean square) measure of amplitude of center of pressure during trial
Time Frame
baseline, immediately post-intervention, same day
Title
Mean velocity
Description
average speed and direction of center of pressure during trial
Time Frame
baseline, immediately post-intervention, same day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
No previous surgeries
Not knowingly pregnant
No neuromusculoskeletal injuries or systemic diseases that could affect an individual's ability to stand on an incline for 3 minutes with their eyes closed.
Exclusion Criteria:
- Weight over the force plate operating limit of 440 lbs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher A Malaya, DC
Organizational Affiliation
Parker University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Synapse Laboratory
City
Dallas
State/Province
Texas
ZIP/Postal Code
75229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Lower Extremity Joint Manipulation on a Lower Extremity Somatosensory Illusion
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