Forefoot VarusNCT04453787
The Effects of Different Types of Foot Orthosis in Adults With Compensatory Forefoot Varus
A study testing Arch support orthoses with forefoot medial wedge, Arch support orthoses and Flat insole in people with Forefoot Varus and Flat Feet, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
Forefoot varus is a type of foot deformities. It is asociate with subtalar joint hyperpronation, and cause too much stress over tissues around foot and lower leg during weight bearing activities. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Forefoot Varus, Flat Feet
- What is being tested?
- Arch support orthoses with forefoot medial wedge, Arch support orthoses and Flat insole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Oct 2020to 30 Sep 2022
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Flexible flatfoot
- Angle of forefoot varus > 6 degree
- Feel leg or foot pain when walking or exercising, and pain visual analogue scale > 3 points
- The duration of wearing shoes > 30 he per week
Who cannot join
- Rigid flatfoot
- Leg length discrepancy > 1cm
- Angle of Hallux valgus > 20 degree
- With any nerve problem or disease
- Used to have trauma over lower limbs
- Had any severe joint deformity or osteoarthritis over lower limbs
Show all 9Show fewer
- Had any acute injury (in two weeks and inflammation)
- Had wearing insole for 6 months
- Can't follow order
Trial locations and contacts
1 site in 1 country.
About this study
Forefoot varus is a type of foot deformities. It is asociate with subtalar joint hyperpronation, and cause too much stress over tissues around foot and lower leg during weight bearing activities.
One of the common interventions for forefoot varus is to use foot orthosis with medial forefoot wedge to accommodate the forefoot deformity. Forefoot varus has been considered as an osseus deformity and caused by insufficient talar torsion during development. However, recent studies have reported forefoot varus may not be an osseus deformity. They might be a result of soft tissue adaption. For example, subtalar joint hyperpronation and ankle equinus could lead to forefoot supination/compensatory forefoot varus, which could be mistaken for osseus forefoot varus after a long period of time. If compensatory forefoot varus is caused by soft tissue adaptions, these adaptions may have a chance to reverse.
Read more
Nowadays, orthoses which applying medial forefoot wedge to accommodate the deformity for forefoot varus deformity, and the other type orthoses which applying rearfoot medial wedge and arch support are both used in subject with forefoot varus deformity.
However, some colleges claims that using medial forefoot wedge to accommodate the deformity of forefoot varus, the deformity may be fixed after a long-term period. However, there were no studies compare the effect of arch support orthosis that with and without medial forefoot wedge.
Read the detailed description
Forefoot varus is a type of foot deformities. It is asociate with subtalar joint hyperpronation, and cause too much stress over tissues around foot and lower leg during weight bearing activities.
One of the common interventions for forefoot varus is to use foot orthosis with medial forefoot wedge to accommodate the forefoot deformity. Forefoot varus has been considered as an osseus deformity and caused by insufficient talar torsion during development. However, recent studies have reported forefoot varus may not be an osseus deformity. They might be a result of soft tissue adaption. For example, subtalar joint hyperpronation and ankle equinus could lead to forefoot supination/compensatory forefoot varus, which could be mistaken for osseus forefoot varus after a long period of time. If compensatory forefoot varus is caused by soft tissue adaptions, these adaptions may have a chance to reverse.
Nowadays, orthoses which applying medial forefoot wedge to accommodate the deformity for forefoot varus deformity, and the other type orthoses which applying rearfoot medial wedge and arch support are both used in subject with forefoot varus deformity.
However, some colleges claims that using medial forefoot wedge to accommodate the deformity of forefoot varus, the deformity may be fixed after a long-term period. However, there were no studies compare the effect of arch support orthosis that with and without medial forefoot wedge.
In consideration of few studies have been done for investigating the effects of different orthoses in subjects with flat foot combined forefoot varus. Thus, the purpose of this study is to investigate the effect of different foot orthoses designs on improving pain, muscle activity and displacement of center of pressure. We hypothesized that both orthoses will have the better effect on improving pain than placebo orthoses ,and muscle activity and displacement of center of pressure of arch support orthoses group will have change which close to normal foot.
- Conditions
- Forefoot Varus, Flat Feet
- Being tested
- Arch support orthoses with forefoot medial wedge, Arch support orthoses, Flat insole
- Keywords
- Forefoot varus, Forefoot medial wedge, Flat foot, Orthoses
- Medical subject headings
- Metatarsus Varus, Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arch support orthoses with forefoot medial wedgeOther
Also called Forefoot medial wedge
The degree of forefoot wedge will be 3 degree. If needed, it could be adjusted. The subjects need to wear the orthoses for at least 30 hour per week during the experiment.
Arch support orthosesOther
The arch support of the orthoses could be adjusted depends on the evaluation of subject. The subjects need to wear the orthoses for at least 30 hour per week during the experiment.
Flat insoleOther
The flat insole used as a placebo intervention. The shape of this insole is flat, and made by soft EVA. It only provide shock absorbtion without any support. The subjects need to wear the orthoses for at least 30 hour per week during the experiment.
| Study group | Role | What they receive |
|---|---|---|
| Arch support orthoses with forefoot medial wedge | Experimental | The intervention of this group include orthoses with arch support and added forefoot medial wedge. Receives: Other: Arch support orthoses with forefoot medial wedge |
| Arch support orthoses | Experimental | The intervention of this group include orthoses with arch support. Receives: Other: Arch support orthoses |
| Flat insole | Sham comparator | This group will wear a flat insole. It is made from ethylene-vinyl acetate copolymer with 4mm thickness. It only provide shock absorbtion. Receives: Other: Flat insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot function index
This questionnaire includes 23 questions. These questions are about how difficult or pain over foot when subjects doing some functional activities.
Measured: Baseline
Foot function index
This questionnaire includes 23 questions. These questions are about how difficult or pain over foot when subjects doing some functional activities.
Measured: 6-week intervention
Pain visual analogue scale (VAS)
The scale is from 0 to 10 points. Zero means no pain, and ten points means extremely painful over subject's foot or leg.
Measured: Baseline
Pain visual analogue scale (VAS)
The scale is from 0 to 10 points. Zero means no pain, and ten points means extremely painful over subject's foot or leg.
Measured: 6-week intervention
Change From Baseline in Global Rating of Change Scale (GROC)
To measure improvements in a patient's condition. The minimum value is -7 and it means a very great deal worse. The maximum values is +7 and it means a very great deal better.
Measured: change from baseline at 6 weeks later
Secondary outcomes (2)
Displacement of center of force of gait cycle (medial-lateral and anterior-posterior)
To determine the displacement of Cof during ambulation. We use F-Scan In-Shoe system to determine dynamic pressure, force and timing information. And to calculate the displacement of center of force of each gait cycle.
Measured: Baseline and after 6-week intervention
Muscle activity of tibialis anterior muscle, peroneal longus and abductor hallucis brevis
Muscle activity during ambulation and single leg standing. We use electromyography to record muscle activity of tibialis anterior muscle, peroneal longus and abductor hallucis brevis.
Measured: Baseline and after 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start5 Oct 2020
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Why it stopped: effected by the epidemic of COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forefoot VarusStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Fen Shih, National Yang Ming Chiao Tung University
- Investigators
- Yi-Fen Shih, PhD, Study director, Department of Physical Therapy and Assistive Technology, National Yang-Ming University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453787
- Sponsor's protocol ID
- YM108087F
- Status last verified
- Oct 2022
- First submitted
- 22 Jun 2020
- Last updated
- 5 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Types of Foot Orthosis in Adults With Compensatory Forefoot Varus
- ClinicalTrials.gov ID
- NCT04453787
- Acronym / sponsor ID
- YM108087F
- Conditions
- Forefoot Varus, Flat Feet
- Keywords
- Forefoot varus, Forefoot medial wedge, Flat foot, Orthoses
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: effected by the epidemic of COVID-19
- Enrolment
- 22 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 1 Jul 2020 (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.
Forefoot varus is a type of foot deformities. It is asociate with subtalar joint hyperpronation, and cause too much stress over tissues around foot and lower leg during weight bearing activities.
One of the common interventions for forefoot varus is to use foot orthosis with medial forefoot wedge to accommodate the forefoot deformity. Forefoot varus has been considered as an osseus deformity and caused by insufficient talar torsion during development. However, recent studies have reported forefoot varus may not be an osseus deformity. They might be a result of soft tissue adaption. For example, subtalar joint hyperpronation and ankle equinus could lead to forefoot supination/compensatory forefoot varus, which could be mistaken for osseus forefoot varus after a long period of time. If compensatory forefoot varus is caused by soft tissue adaptions, these adaptions may have a chance to reverse.
Nowadays, orthoses which applying medial forefoot wedge to accommodate the deformity for forefoot varus deformity, and the other type orthoses which applying rearfoot medial wedge and arch support are both used in subject with forefoot varus deformity.
However, some colleges claims that using medial forefoot wedge to accommodate the deformity of forefoot varus, the deformity may be fixed after a long-term period. However, there were no studies compare the effect of arch support orthosis that with and without medial forefoot wedge.
Detailed description
Forefoot varus is a type of foot deformities. It is asociate with subtalar joint hyperpronation, and cause too much stress over tissues around foot and lower leg during weight bearing activities.
One of the common interventions for forefoot varus is to use foot orthosis with medial forefoot wedge to accommodate the forefoot deformity. Forefoot varus has been considered as an osseus deformity and caused by insufficient talar torsion during development. However, recent studies have reported forefoot varus may not be an osseus deformity. They might be a result of soft tissue adaption. For example, subtalar joint hyperpronation and ankle equinus could lead to forefoot supination/compensatory forefoot varus, which could be mistaken for osseus forefoot varus after a long period of time. If compensatory forefoot varus is caused by soft tissue adaptions, these adaptions may have a chance to reverse.
Nowadays, orthoses which applying medial forefoot wedge to accommodate the deformity for forefoot varus deformity, and the other type orthoses which applying rearfoot medial wedge and arch support are both used in subject with forefoot varus deformity.
However, some colleges claims that using medial forefoot wedge to accommodate the deformity of forefoot varus, the deformity may be fixed after a long-term period. However, there were no studies compare the effect of arch support orthosis that with and without medial forefoot wedge.
In consideration of few studies have been done for investigating the effects of different orthoses in subjects with flat foot combined forefoot varus. Thus, the purpose of this study is to investigate the effect of different foot orthoses designs on improving pain, muscle activity and displacement of center of pressure. We hypothesized that both orthoses will have the better effect on improving pain than placebo orthoses ,and muscle activity and displacement of center of pressure of arch support orthoses group will have change which close to normal foot.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arch support orthoses with forefoot medial wedge | Experimental | Other: Arch support orthoses with forefoot medial wedgeThe intervention of this group include orthoses with arch support and added forefoot medial wedge. |
| Arch support orthoses | Experimental | Other: Arch support orthosesThe intervention of this group include orthoses with arch support. |
| Flat insole | Sham comparator | Other: Flat insoleThis group will wear a flat insole. It is made from ethylene-vinyl acetate copolymer with 4mm thickness. It only provide shock absorbtion. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Flexible flatfoot
- Angle of forefoot varus > 6 degree
- Feel leg or foot pain when walking or exercising, and pain visual analogue scale > 3 points
- The duration of wearing shoes > 30 he per week
Key exclusion criteria (9 listed)
- Rigid flatfoot
- Leg length discrepancy > 1cm
- Angle of Hallux valgus > 20 degree
- With any nerve problem or disease
- Used to have trauma over lower limbs
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 |
|---|---|---|
| Arch support orthoses with forefoot medial wedgeAlso: Forefoot medial wedgeThe degree of forefoot wedge will be 3 degree. If needed, it could be adjusted. The subjects need to wear the orthoses for at least 30 hour per week during the experiment. | Other | Arch support orthoses with forefoot medial wedge |
| Arch support orthosesThe arch support of the orthoses could be adjusted depends on the evaluation of subject. The subjects need to wear the orthoses for at least 30 hour per week during the experiment. | Other | Arch support orthoses |
| Flat insoleThe flat insole used as a placebo intervention. The shape of this insole is flat, and made by soft EVA. It only provide shock absorbtion without any support. The subjects need to wear the orthoses for at least 30 hour per week during the experiment. | Other | Flat insole |
Primary outcome
Foot function index
Time frame: Baseline
This questionnaire includes 23 questions. These questions are about how difficult or pain over foot when subjects doing some functional activities.
Foot function index
Time frame: 6-week intervention
This questionnaire includes 23 questions. These questions are about how difficult or pain over foot when subjects doing some functional activities.
Pain visual analogue scale (VAS)
Time frame: Baseline
The scale is from 0 to 10 points. Zero means no pain, and ten points means extremely painful over subject's foot or leg.
Pain visual analogue scale (VAS)
Time frame: 6-week intervention
The scale is from 0 to 10 points. Zero means no pain, and ten points means extremely painful over subject's foot or leg.
Change From Baseline in Global Rating of Change Scale (GROC)
Time frame: change from baseline at 6 weeks later
To measure improvements in a patient's condition. The minimum value is -7 and it means a very great deal worse. The maximum values is +7 and it means a very great deal better.
2 secondary outcomes
Displacement of center of force of gait cycle (medial-lateral and anterior-posterior)
Time frame: Baseline and after 6-week intervention
Muscle activity of tibialis anterior muscle, peroneal longus and abductor hallucis brevis
Time frame: Baseline and after 6-week intervention
Results and safety
The study was stopped early (reason given: effected by the epidemic of COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
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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.
Yi-Fen Shih, PhD study director
Department of Physical Therapy and Assistive Technology, National Yang-Ming 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 Arch support orthoses with forefoot medial wedge, Arch support orthoses and Flat insole in people with Forefoot Varus and Flat Feet, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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 9 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: stopped early, as of the sponsor's last update on 5 Oct 2022. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: effected by the epidemic of COVID-19). Results are not available in the source record.
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?
Foot function index (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2022.