Posturographic Characteristics of Eccentric, Isometric and Concentric Movements
Primary Purpose
Chronic Pain, Musculoskeletal Pain
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Posturographic evaluation
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Pain focused on measuring balance, postural, postural equilibrium
Eligibility Criteria
Inclusion Criteria:
- subjects with chronic, orthopedic conditions / pain
Exclusion Criteria:
- involving the lower extremities
Sites / Locations
- Optim Orthopedics - DeRenne
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
subjects
Arm Description
participant undergoing posturographic evaluation
Outcomes
Primary Outcome Measures
Stability Score
The Stability Score (calculated as percentage ratio of the actual sway and the theoretical limit of stability) will be used to investigate if there is any difference between healthy controls and subjects affected by chronic pain not involving the lower extremities. Statistical tools such t-tests and correlation coefficients will be used for assess if there is a difference between the two groups
Secondary Outcome Measures
average velocity moment [mm^2/s]
The average velocity moment (calculated as as the product of sway velocity path length) will be used to investigate if there is any difference between healthy controls and subjects affected by chronic pain not involving the lower extremities. Statistical tools such t-tests and correlation coefficients will be used for assess if there is a difference between the two groups
sway path length [mm]
The sway path length (the distance traveled during the test) will be used to investigate if there is any difference between healthy controls and subjects affected by chronic pain not involving the lower extremities. Statistical tools such t-tests and correlation coefficients will be used for assess if there is a difference between the two groups
frequency content [Hz]
The frequency content (calculated using FFT) will be used to investigate if there is any difference between healthy controls and subjects affected by chronic pain not involving the lower extremities. Statistical tools such t-tests and correlation coefficients will be used for assess if there is a difference between the two groups
Full Information
NCT ID
NCT02577653
First Posted
October 2, 2015
Last Updated
February 16, 2017
Sponsor
Carrick Institute for Graduate Studies
1. Study Identification
Unique Protocol Identification Number
NCT02577653
Brief Title
Posturographic Characteristics of Eccentric, Isometric and Concentric Movements
Official Title
Posturographic Characteristics of Eccentric, Isometric and Concentric Movements
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Logistics reason at the data collection site
Study Start Date
October 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carrick Institute for Graduate Studies
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Determine the posturographic characteristics of eccentric, isometric and concentric movements in healthy subjects as well as in subjects with chronic, orthopedic conditions / pain not involving the lower extremities. The squatting movement (going down from a stand up position, bending the ankle, knee and hip joints, and then returning to the stand up position, while not lifting the feet from the supporting ground surface) is a simple motion that involves all three types of movements: eccentric (the going down), isometric (holding the down position for a couple of seconds) and concentric (the coming up). It is hypothesized that non-healthy subjects will not have "smooth" movements, and posturography could be used to separate between healthy and non-healthy subjects.
Detailed Description
Subjects will undergo Computerized Dynamic Posturography (CDP) testing using the modified Clinical Testing of Sensory Integration in Balance (mCTSIB) protocol: the subjects will be required to stand on a hard or compliant surface (a 4" tall foam cushion of known mechanical properties) in a comfortable posture, feet shoulder width, with eyes open or closed, head straight and arms to the side and free to move, gazing forward, and breathing normally. Subsequently, subjects will be asked to stand first on the right leg and then on the left leg, raising the other leg (flexing the hip about 45 degrees), bending (flexing) the knee 90 degrees, keeping the arms extended and moving them laterally (abduct shoulders to 45 degrees and extend both elbows) to help maintaining balance with eyes open. Finally, subjects will be asked to perform 10 repetition of the squatting movement, with the operator pacing them (telling them when to start and when to stop the movements). The results of the mCTSIB, combined with an initial physical and neurological examination will be used to classify the subjects into the healthy and non healthy group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Musculoskeletal Pain
Keywords
balance, postural, postural equilibrium
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
subjects
Arm Type
Other
Arm Description
participant undergoing posturographic evaluation
Intervention Type
Other
Intervention Name(s)
Posturographic evaluation
Intervention Description
Subjects will undergo CDP testing using the modified Clinical Testing of Sensory Integration in Balance (mCTSIB) protocol. Subsequently, subjects will be asked to stand first on the right leg and then on the left leg with eyes open. Finally, subjects will be asked to perform 10 repetition of the squatting movement, with the operator pacing them (telling them when to start and when to stop the movements).
Primary Outcome Measure Information:
Title
Stability Score
Description
The Stability Score (calculated as percentage ratio of the actual sway and the theoretical limit of stability) will be used to investigate if there is any difference between healthy controls and subjects affected by chronic pain not involving the lower extremities. Statistical tools such t-tests and correlation coefficients will be used for assess if there is a difference between the two groups
Time Frame
immediately after data collection
Secondary Outcome Measure Information:
Title
average velocity moment [mm^2/s]
Description
The average velocity moment (calculated as as the product of sway velocity path length) will be used to investigate if there is any difference between healthy controls and subjects affected by chronic pain not involving the lower extremities. Statistical tools such t-tests and correlation coefficients will be used for assess if there is a difference between the two groups
Time Frame
immediately after data collection
Title
sway path length [mm]
Description
The sway path length (the distance traveled during the test) will be used to investigate if there is any difference between healthy controls and subjects affected by chronic pain not involving the lower extremities. Statistical tools such t-tests and correlation coefficients will be used for assess if there is a difference between the two groups
Time Frame
immediately after data collection
Title
frequency content [Hz]
Description
The frequency content (calculated using FFT) will be used to investigate if there is any difference between healthy controls and subjects affected by chronic pain not involving the lower extremities. Statistical tools such t-tests and correlation coefficients will be used for assess if there is a difference between the two groups
Time Frame
immediately after data collection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
subjects with chronic, orthopedic conditions / pain
Exclusion Criteria:
involving the lower extremities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick R Carrick, PhD
Organizational Affiliation
Carrick Institute for Graduate Studies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Optim Orthopedics - DeRenne
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
12. IPD Sharing Statement
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Posturographic Characteristics of Eccentric, Isometric and Concentric Movements
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