Flexible FlatfootNCT06482580
The Effect of Different Exercises on Lower Extremity Performance in Flexible Flatfoot
A study testing PNF exercise, Clam exercise and Short-foot exercise in people with Flexible Flatfoot, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Flexible Flatfoot
- What is being tested?
- PNF exercise, Clam exercise and Short-foot exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation
Ankara, Çankaya, 06540
About this study
Official title: 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.
Read the 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.
- Conditions
- Flexible Flatfoot
- Being tested
- PNF exercise, Clam exercise, Short-foot exercise
- Keywords
- Foot deformities, Intrinsic foot muscle training, Muscle strenghening, Short-foot exercises, Performance, Proprioceptive neuromuscular facilitation
- Medical subject headings
- Flatfoot, Foot Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNF exerciseOther
Ankle and foot exercises practiced for 6 weeks.
Clam exerciseOther
Hip exercise practiced for 6 weeks.
Short-foot exerciseOther
Foot exercise practiced together for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| PNF exercise group | Experimental | 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. Receives: Other: PNF exercise; Other: Short-foot exercise |
| Clam exercise group | Experimental | 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. Receives: Other: Clam exercise; Other: Short-foot exercise |
| Control group | Active comparator | 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. Receives: Other: Short-foot exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medial longitudinal arch height
Medial longitudinal arch height will be evaluated with the navicular drop test.
Measured: 6 weeks
Static foot posture
Static foot posture will be evaluated with Foot Posture Index-6.
Measured: 6 weeks
Secondary outcomes (2)
Isometric muscle strength
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.
Measured: 6 weeks
Lower extremity functional performance
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start30 Apr 2024
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Flexible FlatfootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was designed as an experimental, 3-arm parallel-group, double-blind randomized controlled trial with a 6-week intervention period. The study will be conducted at Toros University physiotherapy and exercise laboratory.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Hande Esen, Mustafa Kemal University
- Investigators
- Dilek Esen, PhD. c, Principal investigator, Gazi University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482580
- Sponsor's protocol ID
- E-77082166-604.01-930455
- Status last verified
- Jul 2024
- First submitted
- 26 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36231295Engkananuwat 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.
PubMed 36910682Okamura 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.
PubMed 31590069Pabon-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.
PubMed 32645830
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06482580
- Acronym / sponsor ID
- E-77082166-604.01-930455
- Conditions
- Flexible Flatfoot
- Keywords
- Foot deformities, Intrinsic foot muscle training, Muscle strenghening, Short-foot exercises, Performance, Proprioceptive neuromuscular facilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This study was designed as an experimental, 3-arm parallel-group, double-blind randomized controlled trial with a 6-week intervention period. The study will be conducted at Toros University physiotherapy and exercise laboratory.
| Arm | Type | Receives |
|---|---|---|
| PNF exercise group | Experimental | Other: PNF exercise, Other: Short-foot exerciseAll 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. |
| Clam exercise group | Experimental | Other: Clam exercise, Other: Short-foot exerciseAll 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. |
| Control group | Active comparator | Other: Short-foot exerciseAll 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PNF exerciseAnkle and foot exercises practiced for 6 weeks. | Other | PNF exercise group |
| Clam exerciseHip exercise practiced for 6 weeks. | Other | Clam exercise group |
| Short-foot exerciseFoot exercise practiced together for 6 weeks. | Other | Clam exercise group, Control group, PNF exercise group |
Primary outcome
Medial longitudinal arch height
Time frame: 6 weeks
Medial longitudinal arch height will be evaluated with the navicular drop test.
Static foot posture
Time frame: 6 weeks
Static foot posture will be evaluated with Foot Posture Index-6.
2 secondary outcomes
Isometric muscle strength
Time frame: 6 weeks
Lower extremity functional performance
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 36231295Huang 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.
- Background: PubMed 36910682Engkananuwat 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.
- Background: PubMed 31590069Okamura 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.
- Background: PubMed 32645830Pabon-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilek Esen, PhD. c principal investigator
Gazi University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNF exercise, Clam exercise and Short-foot exercise in people with Flexible Flatfoot, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medial longitudinal arch height (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06482580, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.