- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06482580
The Effect of Different Exercises on Lower Extremity Performance in Flexible Flatfoot
July 1, 2024 updated by: Dilek Hande Esen, Mustafa Kemal University
Comparison of Effect of Ankle Exercise in PNF Pattern and Clam Exercise on Lower Extremity Muscle Strengh and Performance in Adults With Flexible Flat Feet: A Randomized Controlled Trial
In the study, the effects of two different strengthening exercises combined with short foot exercise on lower extremity functional performance and muscle strength will be examined and compared in adults aged 18-45 years with flexible flatfoot.
This study was designed as an experimental, 3-arm, parallel group, double-blind randomized controlled study that included a 6-week intervention period.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Participants will be randomly divided into 3 different groups (control group, foot-ankle exercise group, hip exercise group).
The control group will be instructed to perform only short foot exercise; the foot-ankle exercise group will be instructed to perform 3-dimensional foot-ankle extension exercise in proprioceptive neuromuscular facilitation (PNF) pattern in addition to short foot exercise; the hip exercise group will be instructed to perform hip abductor and external rotator muscle strengthening exercise (clam exercise) in addition to short foot exercise.
Foot-ankle and hip exercises will be performed against resistance with the help of an elastic band, 3 days a week under the supervision of a physiotherapist and progression will be made by changing to a higher level of difficulty band color every 2 weeks.
Short foot exercise will be performed every day of the week (3 days under the supervision of a physiotherapist; the rest of the days as a home exercise program) and will be progressed by changing position (sitting, standing, on one leg respectively) every 2 weeks.
All exercises will be performed for 6 weeks.
Assessments will be performed at the beginning and end of the exercises by another researcher blinded to group allocation.
Isometric muscle strength of the intrinsic foot, four-way ankle circumference and hip abductor-external rotator muscles, endurance of the plantar flexors, forward jump and dynamic balance performance will be evaluated respectively.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Çankaya
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Ankara, Çankaya, Turkey, 06540
- Gazi University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age range is 18-45 years
- Navicular drop is 10 mm or more
- Getting a value of +6 points or more from the Foot Posture Index-6
Exclusion Criteria:
- Orthopedic and rheumatological diseases of the spinal region and lower extremities
- Surgery history of the spine and lower extremities
- Neurological and systemic disorders
- Describe lower extremity and/or lower back pain in the last 6 months
- Disorders that may affect cognition and balance (otitis media, visual impairment, etc.)
- Body mass index being above normal values (18-24.9 kg/m2)
- Having rigid flat feet and/or hallux rigidus-limitus deformity
- Being involved in regular sports or exercise
- Having received any physiotherapy or rehabilitation treatment for flat feet or hips in the last year
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PNF exercise group
All groups will be subjected to exercise training for 6 weeks: PNF exercise group will receive 3-dimensional (3D) foot-ankle extension exercise and short-foot exercise.
The exercise will be performed 2 days a week under the supervision of a physiotherapist and 1 day as home exercise; KA exercise will be performed daily, 2 days under the supervision of a physiotherapist and the other days as home exercise.
|
Ankle and foot exercises practiced for 6 weeks.
Foot exercise practiced together for 6 weeks.
|
|
Experimental: Clam exercise group
All groups will be subjected to exercise training for 6 weeks: Clam exercise group will receive mussel exercise and short-foot exercise.
The exercise will be performed 2 days a week under the supervision of a physiotherapist and 1 day as home exercise; KA exercise will be performed daily, 2 days under the supervision of a physiotherapist and the other days as home exercise.
|
Foot exercise practiced together for 6 weeks.
Hip exercise practiced for 6 weeks.
|
|
Active Comparator: Control group
All groups will be subjected to exercise training for 6 weeks: Control group will receive only KA exercise and this exercise will be performed daily, 2 days under the supervision of a physiotherapist and the other days as home exercise.
|
Foot exercise practiced together for 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medial longitudinal arch height
Time Frame: 6 weeks
|
Medial longitudinal arch height will be evaluated with the navicular drop test.
|
6 weeks
|
|
Static foot posture
Time Frame: 6 weeks
|
Static foot posture will be evaluated with Foot Posture Index-6.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Isometric muscle strength
Time Frame: 6 weeks
|
Abductor hallucis, flexor digitorum brevis, flexor hallucis brevis, 4-way ankle muscles and hip abductor/external rotator isometric muscle strength will be evaluated using a digital hand-held dynamometer.
|
6 weeks
|
|
Lower extremity functional performance
Time Frame: 6 weeks
|
With plantar flexor focused endurance performance heel raise test; with dynamic balance Y balance test; Single leg forward jump performance will be evaluated with the single leg hop for distance test.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dilek Esen, PhD. c, Gazi University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Pabon-Carrasco M, Castro-Mendez A, Vilar-Palomo S, Jimenez-Cebrian AM, Garcia-Paya I, Palomo-Toucedo IC. Randomized Clinical Trial: The Effect of Exercise of the Intrinsic Muscle on Foot Pronation. Int J Environ Res Public Health. 2020 Jul 7;17(13):4882. doi: 10.3390/ijerph17134882.
- Huang C, Chen LY, Liao YH, Masodsai K, Lin YY. Effects of the Short-Foot Exercise on Foot Alignment and Muscle Hypertrophy in Flatfoot Individuals: A Meta-Analysis. Int J Environ Res Public Health. 2022 Sep 22;19(19):11994. doi: 10.3390/ijerph191911994.
- Engkananuwat P, Kanlayanaphotporn R. Gluteus medius muscle strengthening exercise effects on medial longitudinal arch height in individuals with flexible flatfoot: a randomized controlled trial. J Exerc Rehabil. 2023 Feb 23;19(1):57-66. doi: 10.12965/jer.2244572.286. eCollection 2023 Feb.
- Okamura K, Fukuda K, Oki S, Ono T, Tanaka S, Kanai S. Effects of plantar intrinsic foot muscle strengthening exercise on static and dynamic foot kinematics: A pilot randomized controlled single-blind trial in individuals with pes planus. Gait Posture. 2020 Jan;75:40-45. doi: 10.1016/j.gaitpost.2019.09.030. Epub 2019 Sep 29.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 30, 2024
Primary Completion (Estimated)
July 30, 2024
Study Completion (Estimated)
September 30, 2024
Study Registration Dates
First Submitted
June 26, 2024
First Submitted That Met QC Criteria
June 26, 2024
First Posted (Actual)
July 1, 2024
Study Record Updates
Last Update Posted (Actual)
July 3, 2024
Last Update Submitted That Met QC Criteria
July 1, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-77082166-604.01-930455
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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