Flat FeetNCT05056298
Effect of Insole Added to Exercise in Patients With Bilateral Flexible Flatfoot
A study testing Custom made insole, Strengthening exercises of extrinsic foot muscles and Strengthening exercises of intrinsic foot muscles in people with Flat Feet and Flexible Flatfoot, run by Horus University at 1 site in Egypt.
Trial summary
Pesplanus, commonly known as 'flatfoot,' is a common pathomechanical condition characterized by a lowered medial longitudinal arch (MLA) and exaggerated pronation. There are two general types of flatfoot : flexible flatfoot and rigid flatfoot Flexible flatfoot is the most common form of flat foot. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Flat Feet, Flexible Flatfoot, Balance; Distorted
- What is being tested?
- Custom made insole, Strengthening exercises of extrinsic foot muscles and Strengthening exercises of intrinsic foot muscles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2021to 15 Jan 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Navicular drop tests (NDT) 10 mm or larger difference in the navicular tuberosity heights.
- Age range from 18-30 years from both sexes to limit the effects of arthritic changes that would be caused by bilateral FFF over the age 30.
- BMI 18-30 as the prevalence of flexible flatfoot appears to be higher in individuals with a higher body mass index (BMI).
Who cannot join
- history of lower extremity injuries as fractures, congenital deformities or surgery affecting balance.
- history of cerebral concussions affecting balance.
- visual or vestibular disorders, and/or any neurological deficit affecting balance.
- any sign of foot pain, history of patellofemoral pain syndrome, plantar fasciitis, TA or TP dysfunction affecting foot function and balance.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic, Faculty of Physical Therapy, Horus University, Egypt
Damietta, 34518
About this study
Official title: Effect of Adding Arch Support Insole to Foot Strengthening Exercise in Patients With Bilateral Flexible Flatfoot
Pesplanus, commonly known as 'flatfoot,' is a common pathomechanical condition characterized by a lowered medial longitudinal arch (MLA) and exaggerated pronation. There are two general types of flatfoot : flexible flatfoot and rigid flatfoot Flexible flatfoot is the most common form of flat foot. In adult population, it was reported that prevalence of flexible flatfeet is 13.6%. It has been proved that there is static and dynamic balance deficit in the participants with flatfeet. The extrinsic muscles as posterior tibialis (TP) ) and intrinsic muscles as abductor hallucis (AbdH) act as active subsystem support for the MLA during weight-bearing, standing, and walking. Abnormal alignment of the foot may cause stretch weakness of the foot muscles by elongating beyond the neutral physiological resting position. leading to musculoskeletal dysfunction and overuse injuries. Insoles can assist in maintaining normal alignment of the foot, improve balance as it supports MLA which is essential to stabilize postural sway, they widen the contact surface of the sole of the foot improving stability.
Read the detailed description
Insoles have been used to correct pathomechanical alterations that occur in patients with flexible flat feet, it was reported that they reduced ankle eversion, ankle inversion moment and reduced the load placed on the ankle invertor muscles which must act eccentrically to control over-pronation and support the arch. Insole with intrinsic foot muscle training has been reported to increase strength on flexor hallucis and cross-sectional area of the AbdH muscle in patient with pes planus. Therefore insole combined with short foot exercises is recommended for strengthening intrinsic foot muscles in pes planus.
Wearing hard insole has been reported to improve postural stability as it limits and control the range of foot pronation, correct foot malalignment and promotes a neutral foot position.
Many studies had investigated the effect of using insole alone or exercise program alone or comparing between them on flexible flat foot patients. Up to the knowledge of the primary investigator, this is the first study to investigate the effect of adding arch support insole to strengthening exercise of foot muscles (intrinsic or extrinsic) in terms of dynamic balance, foot function, and foot muscle strength (intrinsic or extrinsic).
- Conditions
- Flat Feet, Flexible Flatfoot, Balance; Distorted, Muscle Weakness
- Being tested
- Custom made insole, Strengthening exercises of extrinsic foot muscles, Strengthening exercises of intrinsic foot muscles, Standard insole
- Medical subject headings
- Flatfoot, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom made insoleOther
Custom made arch support insole with semi-rigid arch support will be made using the casting method, plaster cast of both feet in a subtalar neutral position will be taken from each subject by highly specialized orthotist. The negative casts will be placed in calcaneal vertical position and custommolded orthosis will be fabricated to positive molds obtained from the negative casts with the goal to control the pronation movement of the foot
Strengthening exercises of extrinsic foot musclesOther
Participants will perform extrinsic foot muscles strengthening exercises with both ankles 3 times per week, 20 minutes for 8 weeks. they will be trained using a progressive resistance protocol using Thera-Band elasticated bands. Subjects will be progressed weekly throughout the training period according to progressive resistance protocol for dorsiflexors, planterflexors, evertors and investors muscles.
Strengthening exercises of intrinsic foot musclesOther
The patient will assume the same position as in intrinsic foot muscle assessment, then he will be instructed to hold the position for a count of 10 seconds and attempt to maintain the MLA as steady as possible during the entire time without any compensatory extrinsic foot muscle activity. Following the 10-seconds, slowly and with eccentric control allow the foot to pronate and the MLA to lower to a relaxed state .
Standard insoleOther
Patient will be instructed to wear a standard prefabricated flat insole as a placepo treatment iniside his shoes for 2 months (8 weeks), 6 to 8 hours per day, and adhere to wearing the orthoses during outdoor walking and during extrinsic foot muscle training.
| Study group | Role | What they receive |
|---|---|---|
| Insole and Exercise group | Experimental | will contain 17 patients, they will receive the custom made arch support insole in addition to the strengthening of foot muscles both intrinsic and extrinsic muscles. Receives: Other: Custom made insole; Other: Strengthening exercises of extrinsic foot muscles; Other: Strengthening exercises of intrinsic foot muscles |
| Exercise group | Active comparator | will contain 17 patients, they will receive the standard insole in addition to the strengthening of foot muscles both intrinsic and extrinsic muscles. Receives: Other: Strengthening exercises of extrinsic foot muscles; Other: Strengthening exercises of intrinsic foot muscles; Other: Standard insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic balance
assessing the change in dynamic balance via using star excursion balance test. The individual will be instructed to establish a stable base of support on the stance limb in the middle of the testing grid and maintain it through a maximal reach excursion in one of the prescribed directions. While standing on a single limb, the participant is asked to reach as far as possible with the reaching limb along each reaching line ; lightly touches the line with the most distal portion of the reaching foot without shifting weight to or coming to rest on this foot of the reaching limb, and the maximum reaching distance will be measured by tape measurement, then the participant is asked to return the reaching limb to the beginning position in the center of the grid, reassuming a bilateral stance.
Measured: at baseline and after 2 months of intervention
Foot function
assessing the change in Foot function via using The arabic version of Foot and ankle ability measure questionnaire. It is a 29-item questionnaire divided into two subscales: the FAAM, 21-item Activities of Daily Living Subscale and the FAAM, 8-item Sports Subscale. • Scoring of each item will be based on a 5-point Likert scale (4 to 0) from no difficulty at all' to unable to do. Item score totals range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale. Higher scores represent higher levels of function for each subscale with 100% representing no dysfunction. The score on each of the items is added together to get the item score total which is divided by the highest potential score. This value is then multiplied by 100 to get a percentage
Measured: at baseline and after 2 months of intervention
Extrinsic foot muscle strength
assessing the change in Extrinsic foot muscle strength via using Hand held dynamometer device. Participants will be placed in subtalar neutral position for all testing. The lower leg will be strapped down to stabilize and prevent any accessory movement. Participants will be instructed to pull or push against the device as hard as they could for each direction and the investigator will counteracte that force with both hands for 3 seconds per trial, 3 consecutive trials will be conducted with a 10-second rest between trials. The maximum force (newtons) was used for analysis as the patient peak force .
Measured: at baseline and after 2 months of intervention
Intrinsic foot muscle strength
assessing the change in Intrinsic foot muscle strength via using intrinsic foot muscle test.patient will be directed to Stand in front of a wall, with the feet shoulder width apart and knees slightly flexed. The fingertips may be lightly placed on the wall. In order to achieve subtalar joint neutral, the therapist will gently supinate the feet by lifting all the toes off the floor, then slowly drop the toes down again but maintain the MLA. This most often results in arise of the MLA and the navicular bone, due to the windlass effect via the plantar fascia. If this procedure proves difficult, then simply the patient will be ordered to increase the height of the MLA, by actively trying to approximate the head of the first metatarsal towards the heel, without flexing the toes. While maintaining the MLA, the patient will stand on a single leg, as steady as possible. The fingertips should remain lightly on the wall for balance and fall prevention
Measured: at baseline and after 2 months of intervention. • The therapist will Count to 30 seconds and will observe for the steadiness of the navicular height and for any compensatory extrinsic foot muscle activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start15 Sep 2021
- Primary completion1 Dec 2021
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flat FeetStudies 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, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ramadan Ibraheem Ramadan, Horus University
- Investigators
- Mohamed Ramadan, Demonstrator, Principal investigator, Horus University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056298
- Sponsor's protocol ID
- Ramadan_MSc
- Status last verified
- Sep 2021
- First submitted
- 18 Sep 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Arch Support Insole to Foot Strengthening Exercise in Patients With Bilateral Flexible Flatfoot
- ClinicalTrials.gov ID
- NCT05056298
- Acronym / sponsor ID
- Ramadan_MSc
- Conditions
- Flat Feet, Flexible Flatfoot, Balance; Distorted, Muscle Weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 24 Sep 2021 (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.
Pesplanus, commonly known as 'flatfoot,' is a common pathomechanical condition characterized by a lowered medial longitudinal arch (MLA) and exaggerated pronation. There are two general types of flatfoot : flexible flatfoot and rigid flatfoot Flexible flatfoot is the most common form of flat foot. In adult population, it was reported that prevalence of flexible flatfeet is 13.6%. It has been proved that there is static and dynamic balance deficit in the participants with flatfeet. The extrinsic muscles as posterior tibialis (TP) ) and intrinsic muscles as abductor hallucis (AbdH) act as active subsystem support for the MLA during weight-bearing, standing, and walking. Abnormal alignment of the foot may cause stretch weakness of the foot muscles by elongating beyond the neutral physiological resting position. leading to musculoskeletal dysfunction and overuse injuries. Insoles can assist in maintaining normal alignment of the foot, improve balance as it supports MLA which is essential to stabilize postural sway, they widen the contact surface of the sole of the foot improving stability.
Detailed description
Insoles have been used to correct pathomechanical alterations that occur in patients with flexible flat feet, it was reported that they reduced ankle eversion, ankle inversion moment and reduced the load placed on the ankle invertor muscles which must act eccentrically to control over-pronation and support the arch. Insole with intrinsic foot muscle training has been reported to increase strength on flexor hallucis and cross-sectional area of the AbdH muscle in patient with pes planus. Therefore insole combined with short foot exercises is recommended for strengthening intrinsic foot muscles in pes planus.
Wearing hard insole has been reported to improve postural stability as it limits and control the range of foot pronation, correct foot malalignment and promotes a neutral foot position.
Many studies had investigated the effect of using insole alone or exercise program alone or comparing between them on flexible flat foot patients. Up to the knowledge of the primary investigator, this is the first study to investigate the effect of adding arch support insole to strengthening exercise of foot muscles (intrinsic or extrinsic) in terms of dynamic balance, foot function, and foot muscle strength (intrinsic or extrinsic).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insole and Exercise group | Experimental | Other: Custom made insole, Other: Strengthening exercises of extrinsic foot muscles, Other: Strengthening exercises of intrinsic foot muscleswill contain 17 patients, they will receive the custom made arch support insole in addition to the strengthening of foot muscles both intrinsic and extrinsic muscles. |
| Exercise group | Active comparator | Other: Strengthening exercises of extrinsic foot muscles, Other: Strengthening exercises of intrinsic foot muscles, Other: Standard insolewill contain 17 patients, they will receive the standard insole in addition to the strengthening of foot muscles both intrinsic and extrinsic muscles. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Navicular drop tests (NDT) 10 mm or larger difference in the navicular tuberosity heights.
- Age range from 18-30 years from both sexes to limit the effects of arthritic changes that would be caused by bilateral FFF over the age 30.
- BMI 18-30 as the prevalence of flexible flatfoot appears to be higher in individuals with a higher body mass index (BMI).
Key exclusion criteria (4 listed)
- history of lower extremity injuries as fractures, congenital deformities or surgery affecting balance.
- history of cerebral concussions affecting balance.
- visual or vestibular disorders, and/or any neurological deficit affecting balance.
- any sign of foot pain, history of patellofemoral pain syndrome, plantar fasciitis, TA or TP dysfunction affecting foot function and balance.
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 |
|---|---|---|
| Custom made insoleCustom made arch support insole with semi-rigid arch support will be made using the casting method, plaster cast of both feet in a subtalar neutral position will be taken from each subject by highly specialized orthotist. The negative casts will be placed in calcaneal vertical position and custommolded orthosis will be fabricated to positive molds obtained from the negative casts with the goal to control the pronation movement of the foot | Other | Insole and Exercise group |
| Strengthening exercises of extrinsic foot musclesParticipants will perform extrinsic foot muscles strengthening exercises with both ankles 3 times per week, 20 minutes for 8 weeks. they will be trained using a progressive resistance protocol using Thera-Band elasticated bands. Subjects will be progressed weekly throughout the training period according to progressive resistance protocol for dorsiflexors, planterflexors, evertors and investors muscles. | Other | Exercise group, Insole and Exercise group |
| Strengthening exercises of intrinsic foot musclesThe patient will assume the same position as in intrinsic foot muscle assessment, then he will be instructed to hold the position for a count of 10 seconds and attempt to maintain the MLA as steady as possible during the entire time without any compensatory extrinsic foot muscle activity. Following the 10-seconds, slowly and with eccentric control allow the foot to pronate and the MLA to lower to a relaxed state . | Other | Exercise group, Insole and Exercise group |
| Standard insolePatient will be instructed to wear a standard prefabricated flat insole as a placepo treatment iniside his shoes for 2 months (8 weeks), 6 to 8 hours per day, and adhere to wearing the orthoses during outdoor walking and during extrinsic foot muscle training. | Other | Exercise group |
Primary outcome
Dynamic balance
Time frame: at baseline and after 2 months of intervention
assessing the change in dynamic balance via using star excursion balance test. The individual will be instructed to establish a stable base of support on the stance limb in the middle of the testing grid and maintain it through a maximal reach excursion in one of the prescribed directions. While standing on a single limb, the participant is asked to reach as far as possible with the reaching limb along each reaching line ; lightly touches the line with the most distal portion of the reaching foot without shifting weight to or coming to rest on this foot of the reaching limb, and the maximum reaching distance will be measured by tape measurement, then the participant is asked to return the reaching limb to the beginning position in the center of the grid, reassuming a bilateral stance.
Foot function
Time frame: at baseline and after 2 months of intervention
assessing the change in Foot function via using The arabic version of Foot and ankle ability measure questionnaire. It is a 29-item questionnaire divided into two subscales: the FAAM, 21-item Activities of Daily Living Subscale and the FAAM, 8-item Sports Subscale. • Scoring of each item will be based on a 5-point Likert scale (4 to 0) from no difficulty at all' to unable to do. Item score totals range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale. Higher scores represent higher levels of function for each subscale with 100% representing no dysfunction. The score on each of the items is added together to get the item score total which is divided by the highest potential score. This value is then multiplied by 100 to get a percentage
Extrinsic foot muscle strength
Time frame: at baseline and after 2 months of intervention
assessing the change in Extrinsic foot muscle strength via using Hand held dynamometer device. Participants will be placed in subtalar neutral position for all testing. The lower leg will be strapped down to stabilize and prevent any accessory movement. Participants will be instructed to pull or push against the device as hard as they could for each direction and the investigator will counteracte that force with both hands for 3 seconds per trial, 3 consecutive trials will be conducted with a 10-second rest between trials. The maximum force (newtons) was used for analysis as the patient peak force .
Intrinsic foot muscle strength
Time frame: at baseline and after 2 months of intervention. • The therapist will Count to 30 seconds and will observe for the steadiness of the navicular height and for any compensatory extrinsic foot muscle activity
assessing the change in Intrinsic foot muscle strength via using intrinsic foot muscle test.patient will be directed to Stand in front of a wall, with the feet shoulder width apart and knees slightly flexed. The fingertips may be lightly placed on the wall. In order to achieve subtalar joint neutral, the therapist will gently supinate the feet by lifting all the toes off the floor, then slowly drop the toes down again but maintain the MLA. This most often results in arise of the MLA and the navicular bone, due to the windlass effect via the plantar fascia. If this procedure proves difficult, then simply the patient will be ordered to increase the height of the MLA, by actively trying to approximate the head of the first metatarsal towards the heel, without flexing the toes. While maintaining the MLA, the patient will stand on a single leg, as steady as possible. The fingertips should remain lightly on the wall for balance and fall prevention
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 2 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Mohamed Ramadan, Demonstrator principal investigator
Horus University in Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom made insole, Strengthening exercises of extrinsic foot muscles and Strengthening exercises of intrinsic foot muscles in people with Flat Feet and Flexible Flatfoot, run by Horus University at 1 site in Egypt.
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 3 inclusion and 4 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 2 Mar 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 Egypt. 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?
Dynamic balance (time frame: at baseline and after 2 months of intervention). The study lists 4 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 2 Mar 2022.