Evaluation of the effect of night orthosis on foot and ankle biomechanics in children with flexible flatfoot and gastro-soleus stiffness

Evaluation of the effect of night orthosis on foot and ankle biomechanics in children with flexible flatfoot and gastro-soleus stiffness: Based on Randomized clinical trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210712051853N1

Enrollment

Registered

2021-08-09

Start date

2021-07-23

Completion date

Unknown

Last updated

2021-08-30

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

Conditions

flexible flatfoot with gasrtosoleus stiffness. Flat foot [pes planus] (acquired), unspecified foot

Interventions

Intervention 1: Intervention group: Night orthoses are made of similar 5 mm polypropylene in two pieces, hinged ankle joint, with an extension in the popliteal area and without a joint for the knee, S

Eligibility

Sex/Gender

All

Age

7 Years to 14 Years

Inclusion criteria

Inclusion criteria: Aged 7 to 14 years Have symptomatic flexible flatfoot and gastro-soleus stiffness Normal BMI base on sex and age Pain parameter score of at least 1

Exclusion criteria

Exclusion criteria: Any problems or trauma to the lower extremities Previous Achilles tendon surgery Abnormal ankle bony prominence Inflammatory and / or infectious arthritis Any internal or metabolic disorders Neurological and musculoskeletal problems lower limb length discrepancy Use of any foot orthoses and the calf muscles stretching Any injury or pathology of the foot, knee, hip and/or back

Design outcomes

Primary

Measure	Time frame
Change of the ankle passive dorsiflexion range of motion. Timepoint: at the beginning of the study, three months later and finally two weeks after the second measurement. Method of measurement: Biodex iskinetics and goniometer.;Gastrosoleus muscle stiffness. Timepoint: At the beginning of the study, three months later and finally two weeks after the second measurement. Method of measurement: Biodex iskinetics.;Gait Kinematic. Timepoint: At the beginning of the study, three months later and finally two weeks after the second measurement. Method of measurement: motion analysis.	—

Measure

Time frame

Change of the ankle passive dorsiflexion range of motion. Timepoint: at the beginning of the study, three months later and finally two weeks after the second measurement. Method of measurement: Biodex iskinetics and goniometer.;Gastrosoleus muscle stiffness. Timepoint: At the beginning of the study, three months later and finally two weeks after the second measurement. Method of measurement: Biodex iskinetics.;Gait Kinematic. Timepoint: At the beginning of the study, three months later and finally two weeks after the second measurement. Method of measurement: motion analysis.

—

Secondary

Measure	Time frame
Pain. Timepoint: At the beginning of the study, three months later and finally two weeks after the second measurement. Method of measurement: Wong-Baker FACES scale.;Quality of Life. Timepoint: At the beginning of the study, three months later and finally two weeks after the second measurement. Method of measurement: Pediatric Quality of Life Inventory.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.saeed forghany

Esfahan University of Medical Sciences

saeed_forghany@yahoo.co.uk+98 31 3792 5028

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026