Effect of Insole Added to Exercise in Patients With Bilateral Flexible Flatfoot

NCT ID: NCT05056298

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2022-01-15

Brief 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. 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).

Conditions

Flat Feet; Flexible Flatfoot; Balance; Distorted; Muscle Weakness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Insole and Exercise group

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.

Group Type: EXPERIMENTAL

Custom made insole

Intervention Type: OTHER

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 muscles

Intervention Type: OTHER

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 muscles

Intervention Type: OTHER

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 .

Exercise group

will contain 17 patients, they will receive the standard insole in addition to the strengthening of foot muscles both intrinsic and extrinsic muscles.

Group Type: ACTIVE_COMPARATOR

Strengthening exercises of extrinsic foot muscles

Intervention Type: OTHER

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 muscles

Intervention Type: OTHER

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 insole

Intervention Type: OTHER

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.

Interventions

Custom made insole

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

Intervention Type: OTHER

Strengthening exercises of extrinsic foot muscles

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.

Intervention Type: OTHER

Strengthening exercises of intrinsic foot muscles

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 .

Intervention Type: OTHER

Standard insole

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Navicular drop tests (NDT) 10 mm or larger difference in the navicular tuberosity heights.

2. 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.

3. BMI 18-30 as the prevalence of flexible flatfoot appears to be higher in individuals with a higher body mass index (BMI).

Exclusion Criteria

1. history of lower extremity injuries as fractures, congenital deformities or surgery affecting balance.

2. history of cerebral concussions affecting balance.

3. visual or vestibular disorders, and/or any neurological deficit affecting balance.

4. any sign of foot pain, history of patellofemoral pain syndrome, plantar fasciitis, TA or TP dysfunction affecting foot function and balance.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Horus University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Ramadan Ibraheem Ramadan

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Ramadan, Demonstrator

Role: PRINCIPAL_INVESTIGATOR

Horus University in Egypt

Locations

Outpatient clinic, Faculty of Physical Therapy, Horus University, Egypt

Damietta, , Egypt

Countries

Egypt

Other Identifiers

Ramadan_MSc

Identifier Type: -

Identifier Source: org_study_id