Differences in Foot Biomechanics and the Effect of Foot Core Exercises or Foot Orthotics in Symptomatic Flexible Flatfoot
Sponsor study identifier
Secondary identifiers
OTHER · KU Leuven, Belgium
interventional
48
1 country
1
Study Start
June 1, 2023
Actual (reported)Primary Completion
December 1, 2024
Actual (reported)Study Completion
December 30, 2024
Actual (reported)The overall goal of this study is to evaluate the effect of a foot strengthening program (focused on the intrinsic foot muscles) on ankle and foot joint kinematics and kinetics (rearfoot, midfoot, and forefoot) in patients with symptomatic flexible flat feet. The investigators will also evaluate the effect on intrinsic muscle morphology, foot strength, pain and other symptoms. The investigators will compare to the standard conservative therapy, which is foot orthotic therapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 3, 2023
Actual (reported)May 3, 2023
Actual (reported)June 1, 2023
Actual (reported)December 1, 2024
Actual (reported)December 30, 2024
Actual (reported)Change in lower limb joint angles (degrees)
Joint angles will be measured based on the position of passive markers placed on participants' anatomical landmarks all over the lower limbs. The position of those markers will be tracked by 10 infrared high-speed cameras that surround the walkway (sampled at 100 Hertz (Hz) - type T-10, 1 megapixel, captures 10-bit grayscale using 1120 \* 896 pixels, Vicon Motion System Ltd, Oxford, Metrics, UK). The angular positions of the multiple joints that constitute the lower limb (hip, knee, ankle, chopart, lisfranc and metatarsophalangeal) will be assessed during walking, running, and single leg drop jump in the gait laboratory.
8-week intervention period
Change in lower limb joint angular velocities (degrees/second)
Joint angular velocities are also assessed based on reflexive markers placed on anatomical landmarks. This outcome evaluates the rate of change of a certain joint angle over time. Joint angular velocities will be assessed of the multiple joints that constitute the lower limb (hip, knee, ankle, chopart, lisfranc and metatarsophalangeal) during walking, running and a single leg drop jump in the gait laboratory.
8-week intervention period
Change in joint moments
Joint moments will be determined by coupling kinematic data (joint position and velocities) with plantar pressure data from a specially designed pressure plate (sampled at 200Hz, Footscan, dimension 0.5m x 0.4m, 4096 sensors, 2.8 sensors/cm², RsScan International, Olen, Belgium) embedded in the middle of the runway and placed on top of a force plate (sampled at 1000Hz, Advanced Mechanical Technology Inc., Watertown, MA, USA). Kinetic data will be assessed while walking, running and a single leg drop jump in the gait laboratory.
8-week intervention period
Change in foot muscle strength
8-week intervention period
Change in foot Posture Index
8-week intervention period
Change in navicular drop
8-week intervention period
Change in the OSPRO-YF questionnaire
8-week intervention period
Change in the FAOS questionnaire
8-week intervention period
This group undergoes no intervention.
The investigators put together a specific training program emphasizing the neuromuscular recruitment of the plantar intrinsic foot muscles. This will be colloquially referred to as the "Foot Core Strengthening Program". The most recognized exercise of our program is the short foot exercise. However, as recently other exercises were validated by Gooding et al., we also included following exercises: toe spread out, first-toe extension and second- to fifth-toes extension. Simultaneously, neuromuscular electrical stimulation (NMES) will be provided, as 77% of healthy active people struggle performing contractions of the foot muscles.
A specific training program emphasizing the neuromuscular recruitment of the plantar intrinsic foot muscles. This will be colloquially referred to as the "Foot Core Strengthening Program". The exercises are: short foot exercise, toe spread out, first toe extension, second to fifth toe extension. Simultaneously, neuromuscular electrical stimulation (NMES) will be provided, as 77% of healthy active people struggle performing contractions of the foot muscles.
KU Leuven
Bruges, West Flanders, 8200, Belgium
Kevin Deschamps, PhD, Pod
Musculoskeletal Rehabilitation Research Group, Department of Rehabilitation Sciences, KU Leuven
48 participants (actual enrollment reported by the registry).
First Submitted
March 3, 2023
Change in foot muscle thickness
The thickness of five intrinsic foot muscles (abductor hallucis, flexor digitorum brevis, flexor hallucis, quadratus plantae and abductor digiti minimi) and three extrinsic foot muscles (peronei, tibialis anterior and flexor digitorum longus) will be measured on images obtained using ultrasonography. To obtain those images, the investigators will scan the muscles in a longitudinal view.
8-week intervention period
Change in foot muscle cross-sectional area
The area of five intrinsic foot muscles (abductor hallucis, flexor digitorum brevis, flexor hallucis, quadratus plantae and abductor digiti minimi) and two extrinsic foot muscles (peronei and flexor digitorum longus) will be measured on images obtained using ultrasonography. To obtain those images, the investigators will scan the muscles in a transversal view.
8-week intervention period
Custom-made foot orthotics are the current standard of care (SOC) therapy within this population. Patients choose their own health care provider to customize these orthotics. The sole is made of EVA material whose color and hardness is determined by the podiatrist or bandage maker. Digital scans or plaster of Paris cast will be taken of the participant's non-weightbearing foot (placed in a neutral or corrected position) by a certified pedorthist following the prescription of the orthopaedic surgeon. The geometry of the foot orthotic will encompass a total contact principle with respect to the medial arch. The orthotics will be manufactured using ethyl vinyl acetate (EVA) with a shore ranging between 45 and 60
Custom-made foot orthotics
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
First Posted
May 3, 2023
Study Start
June 1, 2023
Actual (reported)Primary Completion
December 1, 2024
Actual (reported)Study Completion
December 30, 2024
Actual (reported)Last Updated
February 19, 2025
Record last verified: 2025-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: