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

The Effect of a Newly Designed Orthosis with the Capability of Neuromuscular Electrical Stimulation on the Morphology and Strength of Abductor Hallucis Muscle and Correction of Deformity in Women with Mild to Moderate Hallux Valgus Deformity

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200915048725N1

Enrollment

Registered

2020-12-03

Start date

2020-09-22

Completion date

Unknown

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hallux Valgus Deformity. Hallux valgus (acquired), unspecified foot

Interventions

Intervention 1: Intervention group: This group will use the newly designed orthosis with the capability of neuromuscular electrical stimulation for four weeks. Electrical stimulation will be performed

Eligibility

Sex/Gender

Female

Age

19 Years to 44 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Jalali

Iran University of Medical Sciences

marjalali@gmail.com+98 21 2222 0947

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026