NCT02577653

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

October 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 16, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

February 20, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

October 2, 2015

Last Update Submit

February 16, 2017

Conditions

Keywords

balance, posturalpostural equilibrium

Outcome Measures

Primary Outcomes (1)

  • 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

    immediately after data collection

Secondary Outcomes (3)

  • average velocity moment [mm^2/s]

    immediately after data collection

  • sway path length [mm]

    immediately after data collection

  • frequency content [Hz]

    immediately after data collection

Study Arms (1)

subjects

OTHER

participant undergoing posturographic evaluation

Other: Posturographic evaluation

Interventions

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).

subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subjects with chronic, orthopedic conditions / pain

You may not qualify if:

  • involving the lower extremities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Optim Orthopedics - DeRenne

Savannah, Georgia, 31405, United States

Location

MeSH Terms

Conditions

Chronic PainMusculoskeletal Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal Diseases

Study Officials

  • Frederick R Carrick, PhD

    Carrick Institute for Graduate Studies

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 2, 2015

First Posted

October 16, 2015

Study Start

October 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

February 20, 2017

Record last verified: 2017-02

Locations