NCT04125407

The Effect of Sensorimotor Insoles on Gait Parameters in Adults With Flexible Flatfoot

The Effect of Sensorimotor Insoles on Gait Parameters in Adults With Flexible Flatfoot: A Randomised Control Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Palacky University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The flatfoot is one of the most common diagnosis in foot. The main goals of its orthotic intervention in adult population are the control of the rearfoot and midfoot movement, the affection of the forefoot position and the minimalization of painful deformities. However, only low-level evidence exists proving the positive effect of orthotic insoles in these patients. The concept of sensorimotor insoles describes besides the simple mechanical correction also the targeted modulation of activity of muscles participated on the correct foot function. The aim of the project is to assess the influence of customized sensorimotor insoles on the lower limbs' kinematics and the activity of lower limbs' muscles in people with diagnosed flexible flatfoot. The study is designed as a crossover interventional study with experimental and control group (allocation ratio 1:1). Participants' lower limbs' kinematics and muscles activity will be assessed on the baseline measurement, immediately after and 3 months after the intervention with sensorimotor insoles in the experimental group. Also, the subjective perceived effect of intervention will be assessed through the research. After a washout period, experimental and control group will swap their roles and another period of 3 months will follow. Same parameters will be assessed both at the beginning and in the end of each period.

Conditions

• Flexible Flatfoot

Interventions

Type	Name	Description
OTHER	Sensorimotor foot orthoses	The interventional group will receive one customized pair of sensorimotor insoles and will be instructed for their using on a daily bases for the period of 3 months. The duration of using the insoles was established as 1 hour at the day after receiving the insoles. After that, the insoles' tolerance will be assessed based on the email correspondence and further adjustments of insole will be consulted with manufacturer if necessary. Recommended progression in time of using the insoles was established as +1 hour per each day (if possible) with no maximal limit. After 3 weeks, control examination will take place for the control of subjective effect of insoles. Consulting will be offered to the participants through the duration of research. Participants will not undergo any other supplementary treatment (physiotherapy, …) focusing on the flatfoot deformity.

Timeline

• Start date: 2019-10-22
• Primary completion: 2020-06-01
• Completion: 2020-10-01
• First posted: 2019-10-14
• Last updated: 2020-02-10

Locations

1 site across 1 country: Czechia