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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D013130', 'term': 'Spinal Stenosis'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-05-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-05-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2025-05-02', 'studyFirstSubmitQcDate': '2025-05-02', 'lastUpdatePostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Test of Sensory Integration and Balance (MCTSIB) score', 'timeFrame': 'From enrollment to end of 4 weeks and 8 weeks of treatment', 'description': 'MCTSIB is a testing protocol available with BTracks balance system. Patients are asked to stand on a force plate for 20 seconds in four different conditions a) stand on a firm surface with eyes open b) stand on a firm surface with eyes closed c) stand on a foam with eyes open and d) stand on a foam with eyes closed. The path length of the center of pressure movement is quantified with a score. • Center of Pressure (COP) Path Lengths (PLs) under conditions of eyes open (EO), eyes closed (EC), eyes open foam (EOF), and eyes closed foam (ECF); higher values represent worse postural stability'}], 'secondaryOutcomes': [{'measure': 'Numerical pain rating scale (0-10) on neck pain, mid-back pain, and low back pain', 'timeFrame': 'From enrollment to end of 4 weeks and 8 weeks of treatment', 'description': 'Patients will enter the number corresponding to the level of pain in the three regions of the spine into a RedCap system. • Minimum value 0; Maximum value 10; higher values are worse pain scores'}, {'measure': 'Limits of balance while standing on a force plate', 'timeFrame': 'From enrollment to end of 4 weeks and 8 weeks of treatment', 'description': 'Patients will be asked to stand on a force plate and asked to lean forward, backward, and side ways (right and left). The limits of the center of pressure in anterior to posterior and lateral direction will be obtained using balance software. Center of pressure (COP) area is tested in four directions; front left (FL), back left (BL), back right (BR), and front right (FR) with an overall area provided; higher values represent better limits of stability'}, {'measure': 'path length of center of pressure while standing on a single leg stance', 'timeFrame': 'From enrollment to end of 4 weeks and 8 weeks of treatment', 'description': 'Patient will be asked to stand on a single leg for a maximum of 20 seconds. • Center of Pressure (COP) Path Lengths (PLs) for each leg and Asymmetry Index (ASI); higher COP values represent worse postural stability'}, {'measure': 'Timed up and Go test in seconds', 'timeFrame': 'From enrollment to end of 4 weeks and 8 weeks of treatment', 'description': 'Patients will be asked to get up from a chair and walk and time will be recorded. • Time in seconds to complete; greater time in seconds represents worse mobility and balance'}, {'measure': 'time to Sit-to-stand test for 5 repetetions', 'timeFrame': 'From enrollment to end of 4 weeks and 8 weeks of treatment', 'description': 'Patients will be asked to stand from a sitting position on a chair and repeated for 5 times. Time taken will be recorded.\n\nTime in seconds to complete; greater time in seconds represents worse lower extremity performance'}, {'measure': '• Keele STaRT Back', 'timeFrame': 'From enrollment to end of 4 weeks and 8 weeks of treatment', 'description': 'The STarT Back Screening Tool helps primary care clinicians (GPs, physiotherapists etc) to group patients into three categories of risk of poor outcome (persistent disabling symptoms) - low, medium, and high-risk. By being able to categorise patients into these 3 groups, clinicians are then able to target interventions to each sub-group of patients to help outcome.\n\nMinimum value 0; Maximum value 9; higher values represent higher risk of poor outcome'}, {'measure': '• Assessment of Balance Confidence Questionnaire (ABC-6)', 'timeFrame': 'From enrollment to end of 4 weeks and 8 weeks of treatment', 'description': 'This is a functional short form balance confidence questionnaire consisting of 6 questions with a scale of 0-100 for each question.\n\nPercent balance confidence - Minimum value 0%; Maximum value 100%; higher values represent greater balance confidence'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spine', 'low back pain', 'spinal manipulation', 'spinal mobilization', 'spinal stenosis'], 'conditions': ['Spine Condition', 'Low Back Pain']}, 'descriptionModule': {'briefSummary': 'This research study will evaluate human performance and postural balance changes during the course of care with flexion distraction manipulation in multiple chiropractic practices.', 'detailedDescription': '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.\n\nMethods:\n\nAll 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:\n\n* a numerical pain rating index (0-10) for each of the following: headache, neck pain, mid back pain and low back pain\n* Keele STarT Back Screening Tool\n* Assessment of Balance Confidence Questionnaire (ABC-6)\n* Posture testing via force plate: Modified Test of Sensory Integration and Balance (MCTSIB), Single leg stance, limits of stability,\n* 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with spinal pain presenting to participating Chiropractic clinics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New patients with spinal pain,\n* Patients will be between 18-100 years of age.\n* All patients with spinal pain who - can safely stand and perform the basic parameters of the test at a 7 or below on qualitative visual analog scale (QVAS) on pain will be invited to participate.\n\nExclusion Criteria:\n\n-Patients unable to stand normally with more than a 7 / 10 on the QVAS.'}, 'identificationModule': {'nctId': 'NCT06965920', 'briefTitle': 'Influence of Flexion Distraction Manipulation on Measures of Performance and Postural Control', 'organization': {'class': 'OTHER', 'fullName': 'Keiser University College of Chiropractic Medicine'}, 'officialTitle': 'Influence of Flexion Distraction Manipulation on Measures of Performance and Postural Control', 'orgStudyIdInfo': {'id': 'IRB000NV23MG145'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Persons receiving chiropractic care', 'description': 'Cox flexion distraction spinal manipulation/mobilization and other ancillary therapies as deemed fit by the treating clinician'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33411', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Keiser University Spine care clinic', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}], 'overallOfficials': [{'name': 'Maruti R Gudavalli, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Keiser University-West Palm Beach Campus'}, {'name': 'Ralph Kruse, DC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Keiser University-West Palm Beach'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Will be shared as long as the receiving party signs confidentiality agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keiser University College of Chiropractic Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Parker University', 'class': 'OTHER'}, {'name': 'Miami University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Maruti Gudavalli', 'investigatorAffiliation': 'Keiser University College of Chiropractic Medicine'}}}}