Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT06965920
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-18
First Post:
2025-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Flexion Distraction Manipulation on Measures of Performance and Postural Control
Sponsor:
Keiser University College of Chiropractic Medicine
Organization:
Study Overview
Official Title:
Influence of Flexion Distraction Manipulation on Measures of Performance and Postural Control
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study will evaluate human performance and postural balance changes during the course of care with flexion distraction manipulation in multiple chiropractic practices.
Detailed Description:
Objective This research study will evaluate human performance and postural balance changes during the course of care with flexion distraction manipulation in multiple chiropractic practices.
Methods:
All patients who can stand without severe pain (able to stand normally at a 7 or below on qualitative analog visual pain scale \[QVAS\]) will be invited to participate. The goal is to recruit 150 participants from approximately 10 chiropractic practices. Volunteers will be given an informed consent document to read and if eligible and willing to participate will sign the informed consent document. At baseline and each subsequent testing visit, participants will complete the following:
* a numerical pain rating index (0-10) for each of the following: headache, neck pain, mid back pain and low back pain
* Keele STarT Back Screening Tool
* Assessment of Balance Confidence Questionnaire (ABC-6)
* Posture testing via force plate: Modified Test of Sensory Integration and Balance (MCTSIB), Single leg stance, limits of stability,
* Timed up and go and 5 times sit to stand tests The design of this study is observational, pre-post. Posture and performance testing is expected to last no more than 10 minutes per participant per visit. Subjective data will be captured via RedCap while objective data will be recorded by each clinician and uploaded to secure server.
The design of this study is observational, pre-post. Posture and performance testing is expected to last no more than 10 minutes per participant per visit. Subjective data will be captured via RedCap while objective data will be recorded by each clinician and uploaded to secure server.
Methods:
All patients who can stand without severe pain (able to stand normally at a 7 or below on qualitative analog visual pain scale \[QVAS\]) will be invited to participate. The goal is to recruit 150 participants from approximately 10 chiropractic practices. Volunteers will be given an informed consent document to read and if eligible and willing to participate will sign the informed consent document. At baseline and each subsequent testing visit, participants will complete the following:
* a numerical pain rating index (0-10) for each of the following: headache, neck pain, mid back pain and low back pain
* Keele STarT Back Screening Tool
* Assessment of Balance Confidence Questionnaire (ABC-6)
* Posture testing via force plate: Modified Test of Sensory Integration and Balance (MCTSIB), Single leg stance, limits of stability,
* Timed up and go and 5 times sit to stand tests The design of this study is observational, pre-post. Posture and performance testing is expected to last no more than 10 minutes per participant per visit. Subjective data will be captured via RedCap while objective data will be recorded by each clinician and uploaded to secure server.
The design of this study is observational, pre-post. Posture and performance testing is expected to last no more than 10 minutes per participant per visit. Subjective data will be captured via RedCap while objective data will be recorded by each clinician and uploaded to secure server.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: