Foot Posture Index, Hallux Limitus in Patients With Chron... | NCT04607863

Studies
Foot Posture Index, Hallux Limitus in Patients With Chronic Low Back Pain. Gait With Optogait Sensor

NCT04607863

Sponsor

University of Seville

Status

Completed

Last Update Posted

Apr 8, 2021Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Hallux Limitus
Movement, Abnormal
Back Pain Lower Back Chronic

Interventions

Case control

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 23, 2020Actual

Primary Completion Date

Nov 2, 2020Actual

Completion Date

Dec 30, 2020Actual

First Submitted Date

Oct 23, 2020

First Submission Date that Met QC Criteria

Oct 23, 2020

First Posted Date

Oct 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2021

Last Update Posted Date

Apr 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Foot disorders have been recognized as being linked to chronic low back pain

Detailed Description

Foot disorders have been recognized as being linked to chronic low back pain (CLBP), To improve knowledge of the relationship between the limitation of the movement range of hallux (HROML) is important about it can affect the back biomechanical . The aim of this research is to investigate if the HROML may appear as a risk factor of CLBP

HROML affect the foot position, and consecuently may induce to alter as compensatory mechanism the normal biomechanical of the leg, hip and back.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low back pain		Patients with low back pain	Diagnostic Test: Case control
No low back pain		No low back pain patients	Diagnostic Test: Case control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Case control	Diagnostic Test	Is a case-control research	Low back pain No low back pain

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hallux dorsal movement range degrees	Goniometer to examinate the range of hallux dorsal movement	A day, the inclusion day in the study

Secondary Outcomes

Measure	Description	Time Frame
Low back pain	questionnary oswestry disability index	a day, the inclusion day in the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: males and females between 18 to 65 years old Hallux limitus in one or two feet -

Exclusion Criteria:

serious illness, current participation in another research study pregnancy previus foot or back surgery

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Males and females between 18 and 65 years old

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aurora Castro Mendez		Seville		41018	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020857	Hallux Limitus
D020820	Dyskinesias

Ancestor Terms

ID	Term
D005531	Foot Deformities, Acquired
D005530	Foot Deformities
D009140	Musculoskeletal Diseases
D007592	Joint Diseases

Browse Leaves

Not provided

Browse Branches

Not provided