Effects of Foot Core Exercises in Patients With Total Hip Arthroplasty
2026年6月17日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
50
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Melike N Gürel, PT, MSc.
- 電話番号：+905380307826
- メール：melikenazgurel@gmail.com
研究連絡先のバックアップ
- 名前：Gürsoy Coşkun, PT, PhD, Prof.
- 電話番号：+905435394426
- メール：gursoycoskun@hotmail.com
研究場所
-
-
Altındağ
-
Ankara、Altındağ、トルコ（Türkiye）
- 募集
- Hacettepe University
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Hip Exercise Only Group
Hip Rehabilitation Exercise Program
|
5 days per week, 40 minutes per session, for 12 weeks.
|
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実験的：Hip exercise plus Foot Core exercise group
Hip Rehabilitation Exercise Program with Foot-Core Exercise Program
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5 days per week, 40 minutes per session, for 12 weeks.
5 days per week, 40 minutes per session, for 12 weeks
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Ultrasonographic muscle thickness of foot and ankle periarticular structures
時間枠：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.
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From enrollment to the end of treatment at 12 weeks
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Ultrasonographic cross-sectional area of foot and ankle periarticular structures
時間枠：From enrollment to the end of treatment at 12 weeks
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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.
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From enrollment to the end of treatment at 12 weeks
|
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Tone (frequency) of foot and ankle periarticular structures
時間枠：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
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From enrollment to the end of treatment at 12 weeks
|
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Ultrasonographic tendon morphology of foot and ankle segments
時間枠：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
時間枠：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
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From enrollment to the end of treatment at 12 weeks
|
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The damping coefficient of foot and ankle periaticular structures
時間枠：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
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From enrollment to the end of treatment at 12 weeks
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Relaxation time of foot and ankle periarticular structures
時間枠：From enrollment to the end of treatment at 12 weeks
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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
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Creep parameters of foot and ankle periarticular structures
時間枠：From enrollment to the end of treatment at 12 weeks
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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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Evaluation of lower extremity alignment
時間枠：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
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From enrollment to the end of treatment at 12 weeks
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Navicular height during weight-bearing condition
時間枠：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.
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From enrollment to the end of treatment at 12 weeks
|
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Assessment of Hip Flexor Muscle Strength
時間枠：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
|
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Assessment of Balance
時間枠：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
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From enrollment to the end of treatment at 12 weeks
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Assessment of Hip Functional Status
時間枠：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.
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From enrollment to the end of treatment at 12 weeks
|
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Ankle Mobility Measurement
時間枠：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
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From enrollment to the end of treatment at 12 weeks
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Assessment of Foot Posture
時間枠：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
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From enrollment to the end of treatment at 12 weeks
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Assessment of Kinesiophobia
時間枠：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.
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From enrollment to the end of treatment at 12 weeks
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Assessment of the Ability to Forget the Artificial Joint
時間枠：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.
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From enrollment to the end of treatment at 12 weeks
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Assessment of Fear of Falling and Confidence in Avoiding Falls
時間枠：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
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From enrollment to the end of treatment at 12 weeks
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Assessment of Quality of Life
時間枠：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
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From enrollment to the end of treatment at 12 weeks
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Navicular height during non-weight-bearing condition
時間枠：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
時間枠：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.
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From enrollment to the end of treatment at 12 weeks
|
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Assessment of Hip Extensor Muscle Strength
時間枠：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)
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From enrollment to the end of treatment at 12 weeks
|
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Assessment of Hip Abductor Muscle Strength
時間枠：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)
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From enrollment to the end of treatment at 12 weeks
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Assessment of Hip Adductor Muscle Strength
時間枠：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)
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From enrollment to the end of treatment at 12 weeks
|
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Assessment of Knee Flexor Muscle Strength
時間枠：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
時間枠：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
|
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Assessment of Ankle Dorsiflexor Muscle Strength
時間枠：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)
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From enrollment to the end of treatment at 12 weeks
|
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Assessment of Ankle Plantar Flexor Muscle Strength
時間枠：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
時間枠：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
|
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Assessment of Lower Extremity Function
時間枠：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.
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From enrollment to the end of treatment at 12 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：Gürsoy Coşkun, PT, PhD, Prof.、Hacettepe University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年3月23日
一次修了 (推定)
2027年5月3日
研究の完了 (推定)
2027年5月31日
試験登録日
最初に提出
2026年6月7日
QC基準を満たした最初の提出物
2026年6月17日
最初の投稿 (実際)
2026年6月24日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月24日
QC基準を満たした最後の更新が送信されました
2026年6月17日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- FTREK26/20
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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