ClinicalTrials.Veeva

Menu

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

P

Palacky University

Status

Unknown

Conditions

Flexible Flatfoot

Treatments

Other: Sensorimotor foot orthoses

Study type

Interventional

Funder types

Other

Identifiers

NCT04125407
UPOL_FTK_2019_007

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ability to stand and walk without aid or support
  • flat foot deformity confirmed by the Foot Posture Index (FPI-6) score >5 and/or the normalised navicular height truncated <0.21

Exclusion criteria

  • congenital and/or acquired neuromuscular or orthopaedic impairments that severely limit mobility and/or balance
  • any acute pain while standing and/or walking

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

32 participants in 2 patient groups

Interventional
Experimental group
Description:
Experimental group will receive one customized pair of sensorimotor foot orthoses (insoles). Intervention: Other: Sensorimotor foot orthoses with any other supplementary treatment.
Treatment:
Other: Sensorimotor foot orthoses
Control
No Intervention group
Description:
Control group will receive neither orthotic nor other supplementary intervention.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems