Effects of Foot Core Exercises in Patients With Total Hip Arthroplasty
2026년 6월 17일 업데이트: Melike Naz Gürel, Hacettepe University
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?
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.
연구 개요
상태
모병
연구 유형
중재적
등록 (추정된)
50
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Melike N Gürel, PT, MSc.
- 전화번호: +905380307826
- 이메일: melikenazgurel@gmail.com
연구 연락처 백업
- 이름: Gürsoy Coşkun, PT, PhD, Prof.
- 전화번호: +905435394426
- 이메일: gursoycoskun@hotmail.com
연구 장소
-
-
Altındağ
-
Ankara, Altındağ, 터키 (Türkiye)
- 모병
- Hacettepe University
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Hip Exercise Only Group
Hip Rehabilitation Exercise Program
|
5 days per week, 40 minutes per session, for 12 weeks.
|
|
실험적: Hip exercise plus Foot Core exercise group
Hip Rehabilitation Exercise Program with Foot-Core Exercise Program
|
5 days per week, 40 minutes per session, for 12 weeks.
5 days per week, 40 minutes per session, for 12 weeks
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Ultrasonographic muscle thickness of foot and ankle periarticular structures
기간: From enrollment to the end of treatment at 12 weeks
|
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
기간: From enrollment to the end of treatment at 12 weeks
|
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
기간: From enrollment to the end of treatment at 12 weeks
|
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
기간: From enrollment to the end of treatment at 12 weeks
|
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
기간: From enrollment to the end of treatment at 12 weeks
|
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
기간: From enrollment to the end of treatment at 12 weeks
|
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
기간: From enrollment to the end of treatment at 12 weeks
|
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
기간: From enrollment to the end of treatment at 12 weeks
|
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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Evaluation of lower extremity alignment
기간: From enrollment to the end of treatment at 12 weeks
|
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
|
From enrollment to the end of treatment at 12 weeks
|
|
Navicular height during weight-bearing condition
기간: From enrollment to the end of treatment at 12 weeks
|
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.
|
From enrollment to the end of treatment at 12 weeks
|
|
Assessment of Hip Flexor Muscle Strength
기간: From enrollment to the end of treatment at 12 weeks
|
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)
|
From enrollment to the end of treatment at 12 weeks
|
|
Assessment of Balance
기간: From enrollment to the end of treatment at 12 weeks
|
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
|
From enrollment to the end of treatment at 12 weeks
|
|
Assessment of Hip Functional Status
기간: From enrollment to the end of treatment at 12 weeks
|
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.
|
From enrollment to the end of treatment at 12 weeks
|
|
Ankle Mobility Measurement
기간: From enrollment to the end of treatment at 12 weeks
|
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
|
From enrollment to the end of treatment at 12 weeks
|
|
Assessment of Foot Posture
기간: From enrollment to the end of treatment at 12 weeks
|
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
|
From enrollment to the end of treatment at 12 weeks
|
|
Assessment of Kinesiophobia
기간: From enrollment to the end of treatment at 12 weeks
|
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.
|
From enrollment to the end of treatment at 12 weeks
|
|
Assessment of the Ability to Forget the Artificial Joint
기간: From enrollment to the end of treatment at 12 weeks
|
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.
|
From enrollment to the end of treatment at 12 weeks
|
|
Assessment of Fear of Falling and Confidence in Avoiding Falls
기간: From enrollment to the end of treatment at 12 weeks
|
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
|
From enrollment to the end of treatment at 12 weeks
|
|
Assessment of Quality of Life
기간: From enrollment to the end of treatment at 12 weeks
|
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
|
From enrollment to the end of treatment at 12 weeks
|
|
Navicular height during non-weight-bearing condition
기간: From enrollment to the end of treatment at 12 weeks
|
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.
|
From enrollment to the end of treatment at 12 weeks
|
|
Navicular drop
기간: From enrollment to the end of treatment at 12 weeks
|
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.
|
From enrollment to the end of treatment at 12 weeks
|
|
Assessment of Hip Extensor Muscle Strength
기간: From enrollment to the end of treatment at 12 weeks
|
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)
|
From enrollment to the end of treatment at 12 weeks
|
|
Assessment of Hip Abductor Muscle Strength
기간: From enrollment to the end of treatment at 12 weeks
|
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)
|
From enrollment to the end of treatment at 12 weeks
|
|
Assessment of Hip Adductor Muscle Strength
기간: From enrollment to the end of treatment at 12 weeks
|
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)
|
From enrollment to the end of treatment at 12 weeks
|
|
Assessment of Knee Flexor Muscle Strength
기간: From enrollment to the end of treatment at 12 weeks
|
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)
|
From enrollment to the end of treatment at 12 weeks
|
|
Assessment of Knee Extensor Muscle Strength
기간: From enrollment to the end of treatment at 12 weeks
|
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)
|
From enrollment to the end of treatment at 12 weeks
|
|
Assessment of Ankle Dorsiflexor Muscle Strength
기간: From enrollment to the end of treatment at 12 weeks
|
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)
|
From enrollment to the end of treatment at 12 weeks
|
|
Assessment of Ankle Plantar Flexor Muscle Strength
기간: From enrollment to the end of treatment at 12 weeks
|
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)
|
From enrollment to the end of treatment at 12 weeks
|
|
Assessment of Intrinsic Foot Muscle Strength
기간: From enrollment to the end of treatment at 12 weeks
|
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)
|
From enrollment to the end of treatment at 12 weeks
|
|
Assessment of Lower Extremity Function
기간: From enrollment to the end of treatment at 12 weeks
|
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.
|
From enrollment to the end of treatment at 12 weeks
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Gürsoy Coşkun, PT, PhD, Prof., Hacettepe University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 3월 23일
기본 완료 (추정된)
2027년 5월 3일
연구 완료 (추정된)
2027년 5월 31일
연구 등록 날짜
최초 제출
2026년 6월 7일
QC 기준을 충족하는 최초 제출
2026년 6월 17일
처음 게시됨 (실제)
2026년 6월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 17일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- FTREK26/20
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .