The Effect of Sensorimotor Insoles on Gait Parameters in Adults With Flexible Flatfoot: A Randomised Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Palacky University
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Foot kinematics - difference in foot eversion relative to shank during the stance phase of the gait cycle
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Interventional
Experimental group will receive one customized pair of sensorimotor foot orthoses (insoles).
Intervention: Other: Sensorimotor foot orthoses with any other supplementary treatment.
Intervention: Sensorimotor foot orthoses (Other)
Control
Control group will receive neither orthotic nor other supplementary intervention.
Outcomes
Primary Outcomes
Foot kinematics - difference in foot eversion relative to shank during the stance phase of the gait cycle
Time Frame: 3 months
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
Time Frame: 3 months
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 Outcomes
- Surface electromyography - difference in muscle activity by parameter "mean" during the stance phase of the gait cycle(3 months)
Investigators
Zdenek Svoboda
Assistant Professor
Palacky University