NCT07665801

Brief 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 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? 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Mar 2026May 2027

Study Start

First participant enrolled

March 23, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2027

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

1.1 years

First QC Date

June 7, 2026

Last Update Submit

June 17, 2026

Conditions

Keywords

foot core exercisesultrasound imagingultrasonographyPostoperative exercises

Outcome Measures

Primary Outcomes (8)

  • 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.

    From enrollment to the end of treatment at 12 weeks

  • 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.

    From enrollment to the end of treatment at 12 weeks

  • 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

    From enrollment to the end of treatment at 12 weeks

  • 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.

    From enrollment to the end of treatment at 12 weeks

  • 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

    From enrollment to the end of treatment at 12 weeks

  • 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

    From enrollment to the end of treatment at 12 weeks

  • 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

    From enrollment to the end of treatment at 12 weeks

  • 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

    From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (22)

  • Evaluation of lower extremity alignment

    From enrollment to the end of treatment at 12 weeks

  • Navicular height during weight-bearing condition

    From enrollment to the end of treatment at 12 weeks

  • Assessment of Hip Flexor Muscle Strength

    From enrollment to the end of treatment at 12 weeks

  • Assessment of Balance

    From enrollment to the end of treatment at 12 weeks

  • Assessment of Hip Functional Status

    From enrollment to the end of treatment at 12 weeks

  • +17 more secondary outcomes

Study Arms (2)

Hip Exercise Only Group

ACTIVE COMPARATOR

Hip Rehabilitation Exercise Program

Other: Hip Rehabilitation Exercise Program

Hip exercise plus Foot Core exercise group

EXPERIMENTAL

Hip Rehabilitation Exercise Program with Foot-Core Exercise Program

Other: Hip Rehabilitation Exercise ProgramOther: Foot-Core Exercise Program

Interventions

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

Hip Exercise Only GroupHip exercise plus Foot Core exercise group

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

Also known as: Exercise intervention
Hip exercise plus Foot Core exercise group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Altındağ, Turkey (Türkiye)

RECRUITING

Study Officials

  • Gürsoy Coşkun, PT, PhD, Prof.

    Hacettepe University

    STUDY DIRECTOR

Central Study Contacts

Melike N Gürel, PT, MSc.

CONTACT

Gürsoy Coşkun, PT, PhD, Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

June 7, 2026

First Posted

June 24, 2026

Study Start

March 23, 2026

Primary Completion (Estimated)

May 3, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

June 24, 2026

Record last verified: 2026-06

Locations