Flexible FlatfootNCT05896917
Comparison of 3D Printed Foot Orthoses With Prefabricated Foot Orthoses
A study testing 3D Printed Foot Orthosis and Prefabricated Foot Orthosis in people with Flexible Flatfoot, run by Taibah University at 1 site in Saudi Arabia.
Trial summary
The goal of this clinical trial is to compare the effects of 3D printed insoles versus prefabricated insoles in otherwise healthy subjects with flatfoot condition. The main question it aims to answer is: If 3D printed insoles are better in terms of fit, weight, durability, comfort, and effectiveness compared to… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Flexible Flatfoot
- What is being tested?
- 3D Printed Foot Orthosis and Prefabricated Foot Orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 23 May 2023to 8 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of 18 years or above
- Flatfoot symptoms such as foot/calf pain and fatigue after prolonged walking
- Foot postural index ranging from 6 to 12
- No neurological or physical disabilities
Who cannot join
- Below 18 years of age
- Inability to understand or answer questions
- Any lower limb surgery within the past two years
- Any lower limb injury within the past six months
- Any neurological disorder affecting gait
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Medical Rehabilitation Hospital
Madinah, Medina Region
About this study
Official title: Do 3D Printed Foot Orthoses Reduce Self-reported Pain?-a Randomised Controlled Study
The goal of this clinical trial is to compare the effects of 3D printed insoles versus prefabricated insoles in otherwise healthy subjects with flatfoot condition.
The main question it aims to answer is:
Read more
- If 3D printed insoles are better in terms of fit, weight, durability, comfort, and effectiveness compared to prefabricated insoles.
- If 3D printed insoles are better in terms of reducing pain compared to prefabricated insoles.
Participants will be divided in two groups. One group will receive 3D printed insoles and other group will wear prefabricated insoles for four weeks. After four weeks, researchers will record their feedback about their insoles which will help them to compare the two insoles.
Read the detailed description
The purpose of this research is to compare the effects of 3D printed insoles versus prefabricated insoles in flatfoot subjects. This study will recruit healthy adult subjects with flexible flat feet but otherwise good physical and mental health. They will be divided into groups of an equal number of people. Prefabricated insoles will be given to one group, while 3D printed insoles will be given to the other. Subjective feedback will be collected at week zero, when the subjects will be given the insoles to wear, and again at the end of fourth week. Statistical analysis will be used to determine whether or not there is a significant difference in the responses of the two groups. The results will help us in identifying which insoles are better than the other in terms of parameters described above.
- Conditions
- Flexible Flatfoot
- Being tested
- 3D Printed Foot Orthosis, Prefabricated Foot Orthosis
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Printed Foot OrthosisDevice
3D printed foot orthoses designed and fabricated at the Taibah University
Prefabricated Foot OrthosisDevice
Also called Insoles
Generic foot orthoses available commercially
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | This group will receive 3D Printed Foot Orthoses Receives: Device: 3D Printed Foot Orthosis |
| Control | Active comparator | This group will receive Prefabricated Foot Orthoses Receives: Device: Prefabricated Foot Orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
The Visual Analog Scale is a validated tool for assessing pain. It involves a 10-centimeter line with the starting point at 0 centimeters representing no pain and the end point at 10 centimeters representing severe pain. Patients mark their pain level on the line, and the distance from the starting point provides a numerical measure of pain intensity.
Measured: Will be measured at Week 0
Visual Analog Scale
The Visual Analog Scale is a validated tool for assessing pain. It involves a 10-centimeter line with the starting point at 0 centimeters representing no pain and the end point at 10 centimeters representing severe pain. Patients mark their pain level on the line, and the distance from the starting point provides a numerical measure of pain intensity.
Measured: Will be measured at Week 4
Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire.
The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) questionnaire is a tool designed to assess user satisfaction with assistive technology (AT) devices.
A modified version of the QUEST questionnaire that will be used here consists of various items related to different aspects of assistive device use, such as device effectiveness, comfort, durability, weight, and dimensions. Respondents will be asked to rate each item on a scale, ranging from 1 (Not Satisfied at All) to 5 (Very Satisfied), indicating their level of satisfaction with each statement.
Measured: Will be measured at 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start23 May 2023
- Primary completion30 Jul 2023
- Study completion8 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Flexible FlatfootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taibah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Abu Zeeshan Bari, Taibah University
- Investigators
- Abu Z Bari, PhD, Principal investigator, Taibah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896917
- Sponsor's protocol ID
- CMR-PO-2023-421/8
- Status last verified
- Aug 2023
- First submitted
- 22 May 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in this study
Publications
Bari AZ, Ahmed N, Farhan M, Al-Shenqiti A, Zafar MS. Comparing Prefabricated and 3D-Printed Foot Orthoses for the Management of Flat Foot Condition: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2025 Apr 1;104(4):298-304. doi: 10.1097/PHM.0000000000002585. Epub 2024 Jul 3.
PubMed 38958259
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do 3D Printed Foot Orthoses Reduce Self-reported Pain?-a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT05896917
- Acronym / sponsor ID
- CMR-PO-2023-421/8
- Conditions
- Flexible Flatfoot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Taibah UniversityUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare the effects of 3D printed insoles versus prefabricated insoles in otherwise healthy subjects with flatfoot condition.
The main question it aims to answer is:
- If 3D printed insoles are better in terms of fit, weight, durability, comfort, and effectiveness compared to prefabricated insoles.
- If 3D printed insoles are better in terms of reducing pain compared to prefabricated insoles.
Participants will be divided in two groups. One group will receive 3D printed insoles and other group will wear prefabricated insoles for four weeks. After four weeks, researchers will record their feedback about their insoles which will help them to compare the two insoles.
Detailed description
The purpose of this research is to compare the effects of 3D printed insoles versus prefabricated insoles in flatfoot subjects. This study will recruit healthy adult subjects with flexible flat feet but otherwise good physical and mental health. They will be divided into groups of an equal number of people. Prefabricated insoles will be given to one group, while 3D printed insoles will be given to the other. Subjective feedback will be collected at week zero, when the subjects will be given the insoles to wear, and again at the end of fourth week. Statistical analysis will be used to determine whether or not there is a significant difference in the responses of the two groups. The results will help us in identifying which insoles are better than the other in terms of parameters described above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: 3D Printed Foot OrthosisThis group will receive 3D Printed Foot Orthoses |
| Control | Active comparator | Device: Prefabricated Foot OrthosisThis group will receive Prefabricated Foot Orthoses |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age of 18 years or above
- Flatfoot symptoms such as foot/calf pain and fatigue after prolonged walking
- Foot postural index ranging from 6 to 12
- No neurological or physical disabilities
Key exclusion criteria (5 listed)
- Below 18 years of age
- Inability to understand or answer questions
- Any lower limb surgery within the past two years
- Any lower limb injury within the past six months
- Any neurological disorder affecting gait
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D Printed Foot Orthosis3D printed foot orthoses designed and fabricated at the Taibah University | Device | Experimental |
| Prefabricated Foot OrthosisAlso: InsolesGeneric foot orthoses available commercially | Device | Control |
Primary outcome
Visual Analog Scale
Time frame: Will be measured at Week 0
The Visual Analog Scale is a validated tool for assessing pain. It involves a 10-centimeter line with the starting point at 0 centimeters representing no pain and the end point at 10 centimeters representing severe pain. Patients mark their pain level on the line, and the distance from the starting point provides a numerical measure of pain intensity.
Visual Analog Scale
Time frame: Will be measured at Week 4
The Visual Analog Scale is a validated tool for assessing pain. It involves a 10-centimeter line with the starting point at 0 centimeters representing no pain and the end point at 10 centimeters representing severe pain. Patients mark their pain level on the line, and the distance from the starting point provides a numerical measure of pain intensity.
Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire.
Time frame: Will be measured at 4th week
The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) questionnaire is a tool designed to assess user satisfaction with assistive technology (AT) devices. A modified version of the QUEST questionnaire that will be used here consists of various items related to different aspects of assistive device use, such as device effectiveness, comfort, durability, weight, and dimensions. Respondents will be asked to rate each item on a scale, ranging from 1 (Not Satisfied at All) to 5 (Very Satisfied), indicating their level of satisfaction with each statement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Derived from this study: PubMed 38958259Bari AZ, Ahmed N, Farhan M, Al-Shenqiti A, Zafar MS. Comparing Prefabricated and 3D-Printed Foot Orthoses for the Management of Flat Foot Condition: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2025 Apr 1;104(4):298-304. doi: 10.1097/PHM.0000000000002585. Epub 2024 Jul 3.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in this study
Related trials for Flexible Flatfoot
Not yet recruitingObservational study
Tibialis Posterior Muscle Morphology in Flexible Flatfeet Subjects
Flexible Flatfoot
Active, not recruitingObservational study
Clinical and Functional Outcomes After Subtalar Arthroereisis in Pediatric Flexible Flatfoot
Pediatric Flexible Flatfoot
Not yet recruiting
Effect of Foot Orthoses on Kneecap Position in Adults With Flexible Flatfoot
Patellofemoral Joint, Flatfoot
Recruiting
Effects of Hip-Based Versus Knee-Based Exercises on Medial Longitudinal Arch, Dynamic Balance, and Muscle Strength in Flexible Flatfoot
Flexible Flatfoot, Flexible Flatfoot or Pes Planus
Not yet recruiting
Calcaneal Lengthening Osteotomy With Locking Wedge Plate Versus Synthetic PEEK Cage Interposition for Symptomatic Flexible Pes Planovalgus Foot Deformity in Adolescents
Flexible Flatfoot or Pes Planus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abu Z Bari, PhD principal investigator
Taibah University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Printed Foot Orthosis and Prefabricated Foot Orthosis in people with Flexible Flatfoot, run by Taibah University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: Will be measured at Week 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05896917, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.