- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04607863
Foot Posture Index, Hallux Limitus in Patients With Chronic Low Back Pain. Gait With Optogait Sensor
Foot Posture Index Pronated, Hallux Limitus Connection and Chronic Low Back Pain Gait Parametrers With Optogait Sensor
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Sevilla, Spain, 41018
- Aurora Castro Mendez
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
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Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Low back pain
Patients with low back pain
|
Is a case-control research
|
|
No low back pain
No low back pain patients
|
Is a case-control research
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hallux dorsal movement range degrees
Time Frame: A day, the inclusion day in the study
|
Goniometer to examinate the range of hallux dorsal movement
|
A day, the inclusion day in the study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Low back pain
Time Frame: a day, the inclusion day in the study
|
questionnary oswestry disability index
|
a day, the inclusion day in the study
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Wounds and Injuries
- Leg Injuries
- Joint Diseases
- Musculoskeletal Diseases
- Movement Disorders
- Foot Deformities
- Foot Deformities, Acquired
- Foot Injuries
- Back Pain
- Low Back Pain
- Dyskinesias
- Hallux Rigidus
- Hallux Limitus
Other Study ID Numbers
- 23/11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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