Foot and ankle function score, insole durability, and patient satisfaction compared between 3D-printed customized insoles and conventional custom-made insoles in Thai people with flat feet

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20211215008

Enrollment

Registered

2021-12-15

Start date

2019-12-04

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Patients aged older than 12 years who has bilateral flat feet and were prescribed to use the custom-made insoles. Foot and ankle function score, insole durability, patient satisfaction, 3D-printed customized insoles, conventional custom-made insoles, Thai people, flat feet

Interventions

3D-printed customized insoles were fabricated using the 3D digital model from the 3D scanner and computer-aided design (CAD) software and a fused deposition modeling (FDM) type 3D printer. The 3D-prin

Experimental Device,Active Comparator Device

3D-printed customized insoles ,conventional custom-made insoles

Eligibility

Sex/Gender

All

Age

12 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients who has bilateral flat feet 2.Were prescribed custom-made insoles

Exclusion criteria

Exclusion criteria: 1.History of surgery of the foot and/or ankle 2. Negative result of heel raise test 3. fixed foot deformities 4. leg length discrepancy 5. neurological conditions that could affect walking ability 6. active wound 7. impaired cognitive skill 8. use of 3D-printed foot orthoses within the past year

Design outcomes

Primary

Measure	Time frame
Visual analogue score foot and ankle (VAS-FA) Thai version At the base line , 1-month and 3- month after intervention Visual analogue score foot and ankle (VAS-FA)	—

Secondary

Measure	Time frame
Patient satisfaction 3-month post intervention Rubic score 0-4: o is not satisfied, 4 is very satisfied. The survey consisted of four domains (1 question for each domain), as follows: comfort, maintenance, durability, and overall satisfaction,Insole durability At the base line , 1-month and 3- month after intervention Height measured in centimetres (cm).The reduction in navicular height (cm) from baseline	—

Measure

Time frame

Patient satisfaction 3-month post intervention Rubic score 0-4: o is not satisfied, 4 is very satisfied. The survey consisted of four domains (1 question for each domain), as follows: comfort, maintenance, durability, and overall satisfaction,Insole durability At the base line , 1-month and 3- month after intervention Height measured in centimetres (cm).The reduction in navicular height (cm) from baseline

—

Countries

Thailand

Contacts

Public ContactVoraluck Prakotmongkol

Sirindhorn school of prosthetics and orthotics, Faculty of Medicine Siriraj Hospital, Mahidol University

Voraluck.pra@mahidol.edu024193466

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026