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

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.

Study Overview

• Status: Unknown
• Conditions: Flexible Flatfoot
• Intervention / Treatment: Other: Sensorimotor foot orthoses

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Olomouc, Czechia, 77111
    • Faculty of Physical Culture, Palacky University Olomouc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot kinematics - difference in foot eversion relative to shank during the stance phase of the gait cycle	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).	3 months
Foot kinematics - difference in foot external rotation relative to shank during the stance phase of the gait cycle	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).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surface electromyography - difference in muscle activity by parameter "mean" during the stance phase of the gait cycle	The two-way analysis of variance of the mean activity of the tibialis anterior, peroneus longus and gastrocnemius medialis muscles measured by the TrignoTM Wireless Systems (Delsys Inc., Natick, MA, USA) and normalised to their peak activity during the stance phase of the gait cycle, where the factors are the "group" (intervention, control) and "time" (baseline, after 3 months).	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Rating of Change Scale	Subjective evaluation of overall change in health status on the 11-point scale after 3 month from the baseline, where 0 means "unchanged", -5 means "very much worse" and +5 means "completely recovered".	3 months

Collaborators and Investigators

• Sponsor: Palacky University
• Investigators: Study Director: Ondrej Lastovicka, Faculty of Physical Culture, Palacky University Olomouc

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2019
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 14, 2019

Study Record Updates

• Last Update Posted (Actual): February 10, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Flatfoot
• Other Study ID Numbers: UPOL_FTK_2019_007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No