The Effect of a Newly Designed Orthosis on the Hallux Valgus Deformity

Not Applicable

Recruiting

• Conditions: Hallux Valgus Deformity.; Hallux valgus (acquired), unspecified foot; M20.10

• Registration Number: IRCT20200915048725N1
• Lead Sponsor: Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Bilateral or One Sided Hallux Valgus Deformity at Mild or Moderate Severity
1-10 Score Based on Beck Depression Questionnaire
Age Between 19–44 Years
No Rigid Flat Foot and Foot Posture Index (FPI) above 9
History of Pain only in the First Metatarsophalangeal Joint for at least One Month
Conscious Consent of Participants
Accept Study Conditions (for example: Not Wearing Inappropriate Shoes)
Do not Have any Metal Parts on the Foot (Such as Artificial Joints or Any Type of Metal Plate and Bolts) for Magnetic Resonsnce Imaging (MRI)
No History of Orthosis Treatment for Hallux Valgus Deformity

Exclusion Criteria

History of Foot Surgery
Body Mass Index of 30 or more or Very High Weight (100 kg and above)
History of Systemic Diseases Like Rheumatoid Arthritis, Diabetes, Gout, Leprosy; Neurological Disorders and Dislocation and Fracture of Metatarsophalangeal Joints
Experience pain Somewhere other than the First Metatarsophalangeal Joint. For Example, People with Symptomatic Flat Feet and Heel Pain

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hallux Valgus Angle. Timepoint: Before and After of the Intervention. Method of measurement: Goniometer and MRI.

Secondary Outcome Measures

Name	Time	Method
Abductor Hallucis Muscle Strength. Timepoint: Before and After the Intervention. Method of measurement: Loadcell.;Volume of Abductor Hallucis Muscle. Timepoint: Before and After the Intervention. Method of measurement: MRI.;Cross Sectional Area of Abductor Hallucis Muscle. Timepoint: Before and After the Intervention. Method of measurement: MRI.;Intermetatarsal Angle. Timepoint: Before and After the Intervention. Method of measurement: MRI.;Range of Motion of First Metatarsophalangeal Joint. Timepoint: Before and After the Intervention. Method of measurement: Goniometer.;Disability. Timepoint: Before and After the Intervention. Method of measurement: FAAM Questionnaire.