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

Primary Purpose

Flexible Flatfoot

Status
Unknown status
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Sensorimotor foot orthoses
Sponsored by
Palacky University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Flexible Flatfoot

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Faculty of Physical Culture, Palacky University Olomouc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interventional

Control

Arm Description

Experimental group will receive one customized pair of sensorimotor foot orthoses (insoles). Intervention: Other: Sensorimotor foot orthoses with any other supplementary treatment.

Control group will receive neither orthotic nor other supplementary intervention.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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).

Full Information

First Posted
October 10, 2019
Last Updated
February 6, 2020
Sponsor
Palacky University
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1. Study Identification

Unique Protocol Identification Number
NCT04125407
Brief Title
The Effect of Sensorimotor Insoles on Gait Parameters in Adults With Flexible Flatfoot
Official Title
The Effect of Sensorimotor Insoles on Gait Parameters in Adults With Flexible Flatfoot: A Randomised Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 22, 2019 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Palacky University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flexible Flatfoot

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Experimental
Arm Description
Experimental group will receive one customized pair of sensorimotor foot orthoses (insoles). Intervention: Other: Sensorimotor foot orthoses with any other supplementary treatment.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group will receive neither orthotic nor other supplementary intervention.
Intervention Type
Other
Intervention Name(s)
Sensorimotor foot orthoses
Intervention Description
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.
Primary Outcome Measure Information:
Title
Foot kinematics - difference in foot eversion relative to shank during the stance phase of the gait cycle
Description
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).
Time Frame
3 months
Title
Foot kinematics - difference in foot external rotation relative to shank during the stance phase of the gait cycle
Description
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).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Surface electromyography - difference in muscle activity by parameter "mean" during the stance phase of the gait cycle
Description
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).
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Global Rating of Change Scale
Description
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".
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ondrej Lastovicka
Organizational Affiliation
Faculty of Physical Culture, Palacky University Olomouc
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Physical Culture, Palacky University Olomouc
City
Olomouc
ZIP/Postal Code
77111
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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