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Total Hip Arthroplasty (THA)NCT07665801

Effects of Foot Core Exercises in Patients With Total Hip Arthroplasty

A study testing Hip Rehabilitation Exercise Program and Foot-Core Exercise Program in people with Total Hip Arthroplasty (THA), run by Hacettepe University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to investigate the effects of foot core exercises on lower extremity muscle strength, viscoelastic properties, functional parameters, foot and ankle posture, balance, and the morphological characteristics of periarticular structures of the foot and ankle in individuals with total hip… Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Total Hip Arthroplasty (THA)
What is being tested?
Hip Rehabilitation Exercise Program and Foot-Core Exercise Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteTurkey (Türkiye)
Study dates
23 Mar 2026to 31 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Being between 50 and 80 years old,
  • Having at least 2 months elapsed since total hip arthroplasty surgery,
  • Being willing to participate in the study,
  • Being literate.

Who cannot join

  • Having undergone revision total hip arthroplasty surgery,
  • Having a cognitive level below 21 on the MoCA scale, or having any neurological or rheumatological disease,
  • Inability to ambulate,
  • Having any history of lower extremity trauma or other surgical procedures,
  • Having toe-related pathologies that may affect pressure distribution and the course of exercise, such as hallux valgus or Morton's neuroma.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Melike N Gürel, PT, MSc. contact

+905380307826

melikenazgurel@gmail.com

Gürsoy Coşkun, PT, PhD, Prof. contact

+905435394426

gursoycoskun@hotmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Hacettepe University

    Ankara, Altındağ

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Effects of Foot Core Exercises on Lower Extremity Muscle Strength, Functional Parameters, and Morphological and Viscoelastic Properties of Foot and Ankle Periarticular Structures in Patients With Total Hip Arthroplasty

The goal of this clinical trial is to investigate the effects of foot core exercises on lower extremity muscle strength, viscoelastic properties, functional parameters, foot and ankle posture, balance, and the morphological characteristics of periarticular structures of the foot and ankle in individuals with total hip arthroplasty. The main questions it aims to answer are:

  • Does foot core exercises affect morphological characteristics of the periarticular structures surrounding the foot and ankle?
  • Does foot core exercises affect viscoelastic properties of the periarticular structures surrounding the foot and ankle?
  • Does foot core exercises affect lower extremity muscle strength?
  • Does foot core exercises affect lower extremity functional parameters and balance in individuals with total hip arthroplasty?
Read more

The researchers will compare the group performing foot core exercises with the group performing routine hip exercises that do not include foot core exercises.

Participitants will:

  • Participants will receive an exercise log after a specialist physiotherapist demonstrates the exercises in practice at the third postoperative mounth.
  • Visit the clinic every two months from postoperative mounth 3 to month 7 for routine follow-ups and progression of exercises.
  • Except for the control sessions held every two mounths, patients will be followed up through weekly phone calls.
  • Participants will complete an exercise diary indicating that they performed the exercises prescribed for each week, and they will bring their diaries with them to the follow-up sessions.
Being tested
Hip Rehabilitation Exercise Program, Foot-Core Exercise Program
Keywords
foot core exercises, ultrasound imaging, ultrasonography, Postoperative exercises

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hip Rehabilitation Exercise ProgramOther

    5 days per week, 40 minutes per session, for 12 weeks.

  • Foot-Core Exercise ProgramOther

    Also called Exercise intervention

    5 days per week, 40 minutes per session, for 12 weeks

Study groups in NCT07665801
Study groupRoleWhat they receive
Hip Exercise Only GroupActive comparatorHip Rehabilitation Exercise Program
Receives: Other: Hip Rehabilitation Exercise Program
Hip exercise plus Foot Core exercise groupExperimentalHip Rehabilitation Exercise Program with Foot-Core Exercise Program
Receives: Other: Hip Rehabilitation Exercise Program; Other: Foot-Core Exercise Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ultrasonographic muscle thickness of foot and ankle periarticular structures

    The muscle thickness of the foot and ankle periarticular structures will be evaluated using ultrasonography. Ultrasonographic examinations will be performed in accordance with the EURO-MUSCULUS/USPRM foot and ankle protocols (26, 27), using a Clarius ultrasound system (Clarius Mobile Health, 205-2980 Virtual Way, Vancouver, British Columbia, Canada) and a 4-13 MHz linear transducer. All measurements will be conducted by researchers who have received training in ultrasonographic imaging.

    Measured: From enrollment to the end of treatment at 12 weeks

  2. Ultrasonographic cross-sectional area of foot and ankle periarticular structures

    The muscle cross-sectional area of the foot and ankle periarticular structures will be evaluated using ultrasonography. Ultrasonographic examinations will be performed in accordance with the EURO-MUSCULUS/USPRM foot and ankle protocols (26, 27), using a Clarius ultrasound system (Clarius Mobile Health, 205-2980 Virtual Way, Vancouver, British Columbia, Canada) and a 4-13 MHz linear transducer. All measurements will be conducted by researchers who have received training in ultrasonographic imaging.

    Measured: From enrollment to the end of treatment at 12 weeks

  3. Tone (frequency) of foot and ankle periarticular structures

    The MyotonPro device (Myoton AS, Estonia) will be used to evaluate the muscle tone (frequency) (F) of the gastrocnemius medialis (GM),gastrocnemius lateralis (GL) , tibialis anterior (TA), peroneus longus (PL) muscles, the Achilles tendon (AT), and the plantar fascia (PF). Frequency (F) characterizes muscle tone and is reffered as Hz (Hertz). All measurements will be performed on both extremities. To ensure standardization, appropriate anatomical reference points for each structure will be marked prior to measurement

    Measured: From enrollment to the end of treatment at 12 weeks

  4. Ultrasonographic tendon morphology of foot and ankle segments

    The tendon morphology of the foot and ankle muscles will be evaluated using ultrasonography. Ultrasonographic examinations will be performed in accordance with the EURO-MUSCULUS/USPRM foot and ankle protocols (26, 27), using a Clarius ultrasound system (Clarius Mobile Health, 205-2980 Virtual Way, Vancouver, British Columbia, Canada) and a 4-13 MHz linear transducer. All measurements will be conducted by researchers who have received training in ultrasonographic imaging.

    Measured: From enrollment to the end of treatment at 12 weeks

  5. Stiffness of foot and ankle periarticular structures

    The MyotonPro device (Myoton AS, Estonia) will be used to evaluate the stiffness (S) of the gastrocnemius medialis (GM),gastrocnemius lateralis (GL) , tibialis anterior (TA), peroneus longus (PL) muscles, the Achilles tendon (AT), and the plantar fascia (PF). Stiffness (S) reflects the resistance of tissue to an external force that changes its shape and is reffered as N/m (Newton/metre). All measurements will be performed on both extremities. To ensure standardization, appropriate anatomical reference points for each structure will be marked prior to measurement

    Measured: From enrollment to the end of treatment at 12 weeks

  6. The damping coefficient of foot and ankle periaticular structures

    The MyotonPro device (Myoton AS, Estonia) will be used to evaluate the the damping coefficient (D) of gastrocnemius, tibialis anterior (TA), peroneus longus (PL) muscles, the Achilles tendon (AT), and the plantar fascia (PF). The damping coefficient (D) characterizes elasticity. All measurements will be performed on both extremities. To ensure standardization, appropriate anatomical reference points for each structure will be marked prior to measurement

    Measured: From enrollment to the end of treatment at 12 weeks

  7. Relaxation time of foot and ankle periarticular structures

    The MyotonPro device (Myoton AS, Estonia) will be used to evaluate the Rr relaxation time of the gastrocnemius, tibialis anterior (TA), peroneus longus (PL) muscles, the Achilles tendon (AT), and the plantar fascia (PF). The relaxation time (R) of is reffered as mechanical stress and is shown as ms (milliseconds). All measurements will be performed on both extremities. To ensure standardization, appropriate anatomical reference points for each structure will be marked prior to measurement

    Measured: From enrollment to the end of treatment at 12 weeks

  8. Creep parameters of foot and ankle periarticular structures

    The MyotonPro device (Myoton AS, Estonia) will be used to evaluate the creep (C) parameters of the gastrocnemius, tibialis anterior (TA), peroneus longus (PL) muscles, the Achilles tendon (AT), and the plantar fascia (PF). Creep (C) is defined by the ratio of relaxation time to deformation time. All measurements will be performed on both extremities. To ensure standardization, appropriate anatomical reference points for each structure will be marked prior to measurement

    Measured: From enrollment to the end of treatment at 12 weeks

Secondary outcomes (22)
  1. Evaluation of lower extremity alignment

    Lower extremity alignment will be assessed by calculating the Q angle. To evaluate the Q angle, participants will be asked to lie in the supine position with the knee joint in full extension. The Q angle will be measured using a goniometer as the angle formed between a line drawn from the anterior superior iliac spine (ASIS) to the midpoint of the patella and a line drawn from the midpoint of the patella to the tibial tuberosity, and the values will be recorded

    Measured: From enrollment to the end of treatment at 12 weeks

  2. Navicular height during weight-bearing condition

    It is a widely used test for evaluating foot biomechanics disorders and related musculoskeletal problems, used to assess foot arch structure and pronation level (38). The navicular height will be measured in a barefoot full weight-bearing position. The vertical distance between the navicular tuberosity and the ground will be assessed.

    Measured: From enrollment to the end of treatment at 12 weeks

  3. Assessment of Hip Flexor Muscle Strength

    Hip flexion muscle strength will be assessed using a hand-held dynamometer (Lafayette Instrument, Lafayette, IN). The maximal isometric strength will be recorded as Newton (N)

    Measured: From enrollment to the end of treatment at 12 weeks

  4. Assessment of Balance

    Functional mobility and dynamic balance will be assessed using the Timed Up and Go (TUG) test. It is a simple and reliable test that is frequently used in older adults to assess an individual's mobility, balance, walking ability, and risk of falling. The Time Up Go test is commonly used in individuals who have undergone total hip arthroplasty, and it has been shown to have high test-retest reliability and good construct validity in this population

    Measured: From enrollment to the end of treatment at 12 weeks

  5. Assessment of Hip Functional Status

    Hip functional status will be assessed using the Hip Outcome Score. This questionnaire consists of four main parameters assessing pain, functional status in various activities (limping, use of support, walking distance, stair climbing, putting on/taking off socks, sitting, and using public transportation), absence of deformity, and range of motion. Each parameter includes items that evaluate the respective domain, and each response option is assigned a corresponding score. At the end of the questionnaire, these scores are summed to obtain a total score. The questionnaire is scored on a scale from 0 to 100, where 90-100 is classified as excellent, 80-89 as good, 70-79 as moderate, and scores below 70 as poor.

    Measured: From enrollment to the end of treatment at 12 weeks

  6. Ankle Mobility Measurement

    Ankle mobility will be measured using a fluid-filled inclinometer and the weight-bearing lunge test (knee-to-wall test). The knee-to-wall test is a valid and reliable test that assesses joint range of motion in the closed kinetic chain of the lower extremity and provides a passive measure of ankle dorsiflexion range of motion

    Measured: From enrollment to the end of treatment at 12 weeks

  7. Assessment of Foot Posture

    Foot posture will be assessed using the Foot Posture Index in a relaxed standing position, based on six criteria related to the rearfoot and forefoot. Each criterion will be scored on a scale from -2 to +2. Negative values indicate supination, while positive values indicate pronation. Total score represents overall foot posture

    Measured: From enrollment to the end of treatment at 12 weeks

  8. Assessment of Kinesiophobia

    The individuals' fear of movement or avoidance will be assessed using the Tampa Scale for Kinesiophobia (TSK). The TSK is a valid and reliable measure used to evaluate fear of physical activity and fear-avoidance beliefs related to movement. The scale is appropriate for use in individuals who have undergone total hip arthroplasty. This scale consists of 17 items rated on a 4-point Likert scale ranging from "strongly disagree" to "strongly agree." During scoring, items 4, 8, 12, and 16 are reverse scored, and a total score is then calculated. The total score ranges from 17 to 68. A score of 17 indicates no kinesiophobia, while a score of 68 indicates severe fear of movement. The cut-off value of the scale is 37; scores above 37 are considered to indicate high levels of kinesiophobia.

    Measured: From enrollment to the end of treatment at 12 weeks

  9. Assessment of the Ability to Forget the Artificial Joint

    The validated Forgotten Joint Score Questionnaire (FJS-12) will be used to evaluate patients' return to daily life activities following treatment. The FJS-12 is a questionnaire consisting of 12 items that assesses joint awareness during activities of daily living using a 5-point Likert scale. For scoring, all responses are summed and divided by the total number of answered items. The resulting mean value is multiplied by 25 to transform the score to a 0-100 scale, and then subtracted from 100. Higher scores indicate the extent to which the patient is able to forget the operated side (%), reflecting better adaptation to activities of daily living.

    Measured: From enrollment to the end of treatment at 12 weeks

  10. Assessment of Fear of Falling and Confidence in Avoiding Falls

    The International Falls Efficacy Scale (FES-I) will be used to measure the participants' confidence in performing activities of daily living without fear of falling.The FES-I consists of 16 items that assess individuals' confidence in their ability to perform activities. Participants rate each item on a scale from 1 ("no concern at all") to 4 ("very concerned"), resulting in a total score ranging from 16 to 64. Higher scores indicate lower self-confidence in performing daily activities without falling

    Measured: From enrollment to the end of treatment at 12 weeks

  11. Assessment of Quality of Life

    The SF-12 questionnaire will be used to assess participants' quality of life. In the literature, it has been used to measure the quality of life in patients who have undergone hip arthroplasty. The SF-12 consists of 12 items in total, covering questions related to two main domains: physical health and mental health. The questionnaire is scored using computer-based scoring algorithms, and higher scores indicate better health status. With this algorithm, physical health and mental health scores are calculated separately

    Measured: From enrollment to the end of treatment at 12 weeks

  12. Navicular height during non-weight-bearing condition

    It is a widely used test for evaluating foot biomechanics disorders and related musculoskeletal problems, used to assess foot arch structure and pronation level (38). The navicular height will be measured in a non-weight-bearing position. The vertical distance between the navicular tuberosity and the ground will be assessed.

    Measured: From enrollment to the end of treatment at 12 weeks

  13. Navicular drop

    It is a widely used test for evaluating foot biomechanics disorders and related musculoskeletal problems, used to assess foot arch structure and pronation level (38). Navicular drop will be calculated by subtracting the navicular height measured during weight-bearing from the navicular height measured during non-weight-bearing condition.

    Measured: From enrollment to the end of treatment at 12 weeks

  14. Assessment of Hip Extensor Muscle Strength

    Hip extensor muscle strength will be assessed using a hand-held dynamometer (Lafayette Instrument, Lafayette, IN). The maximal isometric strength will be recorded as Newton (N)

    Measured: From enrollment to the end of treatment at 12 weeks

  15. Assessment of Hip Abductor Muscle Strength

    Hip abductor muscle strength will be assessed using a hand-held dynamometer (Lafayette Instrument, Lafayette, IN). The maximal isometric strength will be recorded as Newton (N)

    Measured: From enrollment to the end of treatment at 12 weeks

  16. Assessment of Hip Adductor Muscle Strength

    Hip a dductor muscle strength will be assessed using a hand-held dynamometer (Lafayette Instrument, Lafayette, IN). The maximal isometric strength will be recorded as Newton (N)

    Measured: From enrollment to the end of treatment at 12 weeks

  17. Assessment of Knee Flexor Muscle Strength

    Knee flexor muscle strength will be assessed using a hand-held dynamometer (Lafayette Instrument, Lafayette, IN). The maximal isometric strength will be recorded as Newton (N)

    Measured: From enrollment to the end of treatment at 12 weeks

  18. Assessment of Knee Extensor Muscle Strength

    Knee extensor muscle strength will be assessed using a hand-held dynamometer (Lafayette Instrument, Lafayette, IN). The maximal isometric strength will be recorded as Newton (N)

    Measured: From enrollment to the end of treatment at 12 weeks

  19. Assessment of Ankle Dorsiflexor Muscle Strength

    Ankle Dorsiflexor muscle strength will be assessed using a hand-held dynamometer (Lafayette Instrument, Lafayette, IN). The maximal isometric strength will be recorded as Newton (N)

    Measured: From enrollment to the end of treatment at 12 weeks

  20. Assessment of Ankle Plantar Flexor Muscle Strength

    Ankle plantar flexor muscle strength will be assessed using a hand-held dynamometer (Lafayette Instrument, Lafayette, IN). The maximal isometric strength will be recorded as Newton (N)

    Measured: From enrollment to the end of treatment at 12 weeks

  21. Assessment of Intrinsic Foot Muscle Strength

    Intrinsic foot muscle muscle strength will be assessed using a hand-held dynamometer (Lafayette Instrument, Lafayette, IN). The maximal isometric strength will be recorded as Newton (N)

    Measured: From enrollment to the end of treatment at 12 weeks

  22. Assessment of Lower Extremity Function

    Lower extremity function will be assessed using the Lower Extremity Function Score (LEFS). It consists of 20 questions related to activities of daily living. It is used by clinicians to assess patients' baseline, progressive, and final functional status. It allows evaluation of deteriorating functional capacity in patients. For each row, the degree of ability to perform the specified function is scored from 0 to 4 across columns (0 = extreme difficulty or inability to perform the activity, 4 = no difficulty at all). The maximum possible score is 80. In our study, the LEFS (%) was calculated as: (LEFS score / 80) × 100. A low score indicates severe functional limitation, whereas a high score indicates good functional status. The minimal clinically important difference for the scale score is 9.

    Measured: From enrollment to the end of treatment at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2026
  2. Study start23 Mar 2026
  3. Primary completion3 May 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

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
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07665801
Sponsor's protocol ID
FTREK26/20
Status last verified
Jun 2026
First submitted
7 Jun 2026
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Hip Rehabilitation Exercise Program and Foot-Core Exercise Program in people with Total Hip Arthroplasty (THA), run by Hacettepe 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 24 Jun 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Melike N Gürel, PT, MSc. (+905380307826, melikenazgurel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ultrasonographic muscle thickness of foot and ankle periarticular structures (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 24 Jun 2026.

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