The Effect of Sensorimotor Insoles on Gait Parameters in Adults With Flexible Flatfoot
NCT ID: NCT04125407
Last Updated: 2020-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
32 participants
INTERVENTIONAL
2019-10-22
2020-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
SINGLE
Study Groups
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Interventional
Experimental group will receive one customized pair of sensorimotor foot orthoses (insoles).
Intervention: Other: Sensorimotor foot orthoses with any other supplementary treatment.
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.
Control
Control group will receive neither orthotic nor other supplementary intervention.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* flat foot deformity confirmed by the Foot Posture Index (FPI-6) score \>5 and/or the normalised navicular height truncated \<0.21
Exclusion Criteria
* any acute pain while standing and/or walking
18 Years
ALL
No
Sponsors
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Palacky University
OTHER
Responsible Party
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Zdenek Svoboda
Assistant Professor
Principal Investigators
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Ondrej Lastovicka
Role: STUDY_DIRECTOR
Faculty of Physical Culture, Palacky University Olomouc
Locations
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Faculty of Physical Culture, Palacky University Olomouc
Olomouc, , Czechia
Countries
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Other Identifiers
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UPOL_FTK_2019_007
Identifier Type: -
Identifier Source: org_study_id
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