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Clinical Trials/NCT04125407
NCT04125407
Unknown
Not Applicable

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

Palacky University1 site in 1 country32 target enrollmentOctober 22, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Flexible Flatfoot
Sponsor
Palacky University
Enrollment
32
Locations
1
Primary Endpoint
Foot kinematics - difference in foot eversion relative to shank during the stance phase of the gait cycle
Last Updated
6 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 22, 2019
End Date
October 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zdenek Svoboda

Assistant Professor

Palacky University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Foot kinematics - difference in foot eversion relative to shank during the stance phase of the gait cycle

Time Frame: 3 months

The two-way analysis of variance of the degree of the first peak of foot eversion measured by the optoelectronic system Vicon Vantage (Vicon Motion Systems Ltd., Oxford, Great Britain), where the factors are the "group" (intervention, control) and "time" (baseline, after 3 months).

Foot kinematics - difference in foot external rotation relative to shank during the stance phase of the gait cycle

Time Frame: 3 months

The two-way analysis of variance of the degree of the first peak of foot external rotation measured by the optoelectronic system Vicon Vantage (Vicon Motion Systems Ltd., Oxford, Great Britain), where the factors are the "group" (intervention, control) and "time" (baseline, after 3 months).

Secondary Outcomes

  • Surface electromyography - difference in muscle activity by parameter "mean" during the stance phase of the gait cycle(3 months)

Study Sites (1)

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