Viewing Study NCT06313125



Ignite Creation Date: 2024-05-06 @ 8:15 PM
Last Modification Date: 2024-10-26 @ 3:23 PM
Study NCT ID: NCT06313125
Status: COMPLETED
Last Update Posted: 2024-06-03
First Post: 2024-03-02

Brief Title: Comparison of Exercise Effects in Individuals With Flatfoot
Sponsor: Mustafa Kemal University
Organization: Mustafa Kemal University

Study Overview

Official Title: Comparison of Effects Three-Dimensional Foot-Ankle Exercise and Hip Abductor and External Rotator Strengthening Exercise With Flexible Flatfoot Individuals Randomized Controlled Study
Status: COMPLETED
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Flexible flatfoot deformity also known as flexible pes planus is a common pathological condition characterized by decreased medial longitudinal arch height eversion of the calcaneus and abduction of the forefoot especially during loading Conservative treatments are generally considered as the first step in treatment In conservative treatments exercise methods are one of the most frequently used interventions It has been reported that exercise can improve functional outcomes such as navicular drop plantar pressure distribution foot posture balance and muscle strength in adults with flexible flatfoot Although it is known that intrinsic muscle strengthening exercises are a frequently used intervention method in foot pathologies there is a deficiency in the literature regarding studies investigating the effect of the combination of the most basic foot intrinsic muscle strengthening exercises with different exercise interventions on targeted clinical gains However the effect of three-dimensional foot-ankle exercise on flat feet is unknown Additionally there are a limited number of studies in the literature investigating the effects of hip abductor and external rotator muscle strength training on foot posture in individuals with flat feet The aim of this thesis study planned in the light of this information is to determine the effects of three-dimensional foot-ankle extension exercises and hip abductor-external rotator muscle strengthening exercise primarily on navicular drop and MLA height in individuals with flexible flat feet Secondly it is to examine and compare the effects of static foot posture hip abductorexternal rotator ankle circumference and intrinsic muscle strength on the functional performance of the lower extremity endurance dynamic balance and single leg forward jumping performance To our knowledge this study will be the first randomized controlled study to examine and compare the effects of two different exercise interventions that exercise the proximal and distal regions in flatfoot rehabilitation and the results obtained will contribute to the development of better exercise and treatment programs in this population In individuals with flat feet when hip abductorexternal rotator strengthening exercises or 3D foot-ankle extension exercises in the PNF pattern are added to short-foot exercise MLA structure muscle strength and lower extremity function will be improved more and when these exercises are combined with short-foot exercise they are comparable to intrinsic muscle strengthening exercises alone The investigators hypothesized that it would produce superior clinical results
Detailed Description: This study was designed as an experimental 3-arm parallel group single-blind randomized controlled study that included a 6-week intervention period The study will be carried out in the university physiotherapy and exercise laboratory Flat-footed individuals aged between 18-50 years will be included in this study G-Power Windows version 3197 statistical program was used to determine the number of participants Sample size calculation was made based on a similar study in the literature that evaluated the amount of navicular drop after foot intrinsic muscle strength training the primary outcome measure of this study Type 1 error probability 001 The power was accepted as 090 and the number of samples was determined as at least 15 people for each group By adding the 20 loss rate to this number it was decided that the required number of participants would be 20 people in total for each group Participants who were confirmed to be included in the study were evaluated by the lead investigator who was not involved in the evaluations using Random Allocation Software version 20 in a single block format 3-dimensional foot-ankle exercise group foot muscle exercise group AEG hip abductor and external rotator strengthening exercise will be allocated to three different groups group hip muscles exercise group KEG and control group CG The investigator performing the assessments will be blinded to group allocation Recording of groups demographic information and assessment of outcome measures will be performed by a secondary investigative physical therapist who is blinded to group information The principal investigator physiotherapist will be responsible for training the participants to perform the exercises assigned to them communicating with the participants to monitor exercise performance and exercise compliance allocating the groups and ensuring blinding Outcome measurements will be repeated at the start of treatment and at the end of treatment

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None