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

NCT04125407 | Unknown

• 1 other identifier: UPOL_FTK_2019_007
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Flexible Flatfoot

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  3 months

Other Outcomes (1)

• Global Rating of Change Scale

  3 months

Study Arms (2)

Interventional

EXPERIMENTAL

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

Control

NO INTERVENTION

Control group will receive neither orthotic nor other supplementary intervention.

Interventions

Sensorimotor foot orthoses OTHER

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.

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Palacky University: lead

Study Sites (1)

Faculty of Physical Culture, Palacky University Olomouc

Olomouc, 77111, Czechia

Location

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ondrej Lastovicka

  Faculty of Physical Culture, Palacky University Olomouc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 14, 2019
• Study Start: October 22, 2019
• Primary Completion: June 1, 2020
• Study Completion: October 1, 2020
• Last Updated: February 10, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)