Imam Abdulrahman Bin Faisal University
Dammam, Eastren, Saudi Arabia
NCT Number: NCT04480177
Orthotic therapy or exercise therapy is the standard conservative treatment for flexible flat foot. Little is known about the effectiveness of their interaction on managing flatfoot.
The study aims to evaluate the effect of insoles and short foot exercise on the height and area of the medial longitudinal arch of flexible flatfoot participants as well as the force and pressure.
Looking for future studies?
Notify Me18 year–36 year
All sexes
Interventional
Not applicable
Dammam, Eastren, Saudi Arabia
Study design: A parallel, active-control study design was used to conduct a single-blinded randomized controlled trial.
Method: The toe rising test, the "too many toes" sign, and the navicular drop test was used to select 30 participants with flexible flatfoot. Participants was randomly assigned either to an experimental group (n = 15) or a control group (n = 15). The experimental group received short foot exercises (SFE) and insoles, and the control group received only insoles. SFE was implemented 30 times for a duration of three minutes each day over the course of six weeks. The exercise progressed from sitting to standing and finally to one leg stance position within every two weeks. The participants wore shoes containing orthotic insoles for eight hours per day for six weeks. The EMED-x system was used to measure plantar pressure distribution (force, area, and pressure) at baseline and at two-week intervals throughout the six-week intervention. The Lower Extremity Functional Scale (LEFS) was used to evaluate restriction in participants' functional abilities, and the navicular drop test (NDT) was used to assess the medial longitudinal arch (MLA) height. Both variables were measured at baseline and at the sixth week.
Statistics: Mixed-effects ANOVA was used to test for significant interactions between the two groups across time and within-subject observations of the outcomes.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
the subject was instructed to wear foot insole for 8 hours.
the subject was instructed to perform exercise once a day 30 repetitions.
Time frame: 6 weeks
The feet plantar pressure was measured at baseline and at two-week intervals throughout the six-week intervention.
Time frame: 6 weeks
The Lower extremities functional scale was used to evaluate restriction in participants' functional abilities, The score ranges from 0 to 80, and if it is higher indicating less functional restrictions. The navicular drop test was used to assess the medial longitudinal arch (MLA) height, A positive result for the navicular drop test is an arch height more than or equal to 10 mm. Both variables were measured at baseline and at the sixth week.
Imam Abdulrahman Bin Faisal University
Other
Effect of Intrinsic Foot Muscles Training and Foot Orthosis on the Medial Longitudinal Arch in Flexible Flatfoot Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06401954
Congenital Abnormalities, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Taipei, Taiwan
View Trial DetailsNCT06567509
Congenital Abnormalities, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Kuantan, Pahang, Malaysia
View Trial DetailsNCT06539533
Congenital Abnormalities, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Cairo, Egypt
View Trial DetailsNCT06879756
Back Injuries, Congenital Abnormalities
Cairo, Egypt
View Trial Details