Clinical trial NCT04125407: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Flexible Flatfoot
Lead sponsor: Palacky University
Sponsor class: OTHER
First posted: 2019-10-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Foot kinematics - difference in foot eversion relative to shank during the stance phase of the gait cycle
timeFrame: 3 months
measure: Foot kinematics - difference in foot external rotation relative to shank during the stance phase of the gait cycle
timeFrame: 3 months
Secondary outcomes:
measure: Surface electromyography - difference in muscle activity by parameter "mean" during the stance phase of the gait cycle
timeFrame: 3 months
Other outcomes:
measure: Global Rating of Change Scale
timeFrame: 3 months
Locations:
city: Olomouc
country: Czechia
facility: Faculty of Physical Culture, Palacky University Olomouc
Study officials:
affiliation: Faculty of Physical Culture, Palacky University Olomouc
name: Ondrej Lastovicka
role: STUDY_DIRECTOR
References: