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

Not Applicable

Completed

• Conditions: Muscle Weakness; Flat Feet; Flexible Flatfoot; Balance; Distorted
• Interventions: Other: Custom made insole; Other: Strengthening exercises of extrinsic foot muscles; Other: Strengthening exercises of intrinsic foot muscles; Other: Standard insole

• Registration Number: NCT05056298
• Lead Sponsor: Horus University

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).

Study Timeline

• Status Verified: 2021-09
• Study Start: 2021-09-15
• Study First Submitted: 2021-09-18
• Study First Submitted QC: 2021-09-20
• Study First Posted: 2021-09-24
• Primary Completion: 2021-12-01
• Study Completion: 2022-01-15
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise group	Strengthening exercises of intrinsic foot muscles	will contain 17 patients, they will receive the standard insole in addition to the strengthening of foot muscles both intrinsic and extrinsic muscles.
Insole and Exercise group	Custom made insole	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.
Insole and Exercise group	Strengthening exercises of intrinsic foot muscles	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.
Exercise group	Strengthening exercises of extrinsic foot muscles	will contain 17 patients, they will receive the standard insole in addition to the strengthening of foot muscles both intrinsic and extrinsic muscles.
Insole and Exercise group	Strengthening exercises of extrinsic foot muscles	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.
Exercise group	Standard insole	will contain 17 patients, they will receive the standard insole in addition to the strengthening of foot muscles both intrinsic and extrinsic muscles.

Primary Outcome Measures

Name	Time	Method
Foot function	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	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 .
Dynamic balance	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.
Intrinsic foot muscle strength	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

Trial Locations

Locations (1)

Outpatient clinic, Faculty of Physical Therapy, Horus University, Egypt; 🇪🇬 Damietta, Egypt