Effects of Custom 3D Printed Insoles and Short Foot Exercises in Pes Planus
The Effect of Custom 3D Printed Insoles and Short Foot Exercises on Foot Posture, Balance, and Gait Parameters in Individuals With Pes Planus
The primary purpose of this study is to evaluate the effects of combining custom 3D-printed medial arch-supported insoles with short foot exercises on foot posture, balance, and gait parameters in individuals with pes planus (flat feet). Furthermore, the study will investigate the impact of this combined intervention on secondary outcomes, including pain levels, health-related quality of life, and functional exercise capacity measured by the 6-Minute Walk Test.
調査の概要
詳細な説明
Participants will be recruited through personal networks and social media platforms using a snowball sampling method. Potential candidates will be screened for pes planus in accordance with established literature protocols, utilizing the Foot Posture Index-6 (FPI-6) and the Navicular Drop Test.
Eligible individuals who meet the criteria for pes planus will undergo 3D foot scanning. Based on the obtained data, customized medial arch-supported insoles will be manufactured using 3D printing technology. Participants will be instructed to use these custom insoles in their daily lives for a total of 8 weeks. Concurrently, they will be assigned a daily short foot exercise (intrinsic muscle training) program. Each exercise repetition will involve a 5-second hold, and the entire protocol will be maintained for 8 weeks.
All clinical, functional, and biomechanical evaluations-including foot posture, dynamic balance, comprehensive gait and plantar pressure analysis (via the Zebris system), pain intensity, quality of life, and functional walking capacity-will be conducted at two time points: at baseline and at the end of the 8-week intervention period.
For statistical analysis, depending on the normality of data distribution, either a paired t-test or a Wilcoxon signed-rank test will be used to evaluate within-group changes between baseline and week 8. To determine the magnitude of the intervention effect, Cohen's d effect sizes for dependent measures will be calculated and reported alongside 95% confidence intervals.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ayse Kocak Sezgin, Phd
- 電話番号：+90 5072243706
- メール：ayse.kocaksezgin@ksbu.edu.tr
研究連絡先のバックアップ
- 名前：Emrah Afsar, Phd
- 電話番号：5062527008
- メール：emrah.afsar@ksbu.edu.tr
研究場所
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Kütahya、トルコ（Türkiye）
- 募集
- Kutahya Health Science University
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コンタクト：
- Emrah Afsar, Phd
- 電話番号：5062527008
- メール：emrah.afsar@ksbu.edu.tr
-
主任研究者：
- Emrah Afsar, Phd
-
副調査官：
- Zeynep Sena Namaz, MSc
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Aged between 18 and 35 years.
- Presence of pes planus, defined as a Navicular Drop test value > 10 mm and a Foot Posture Index-6 (FPI-6) score between +6 and +12.
- Willingness to volunteer for the study and provide written informed consent.
Exclusion Criteria:
- Presence of rigid pes planus.
- Hallux valgus.
- Hallux rigidus.
- Calcaneal spur (heel spur).
- History of any neurological, cardiovascular, or systemic diseases.
- History of any orthopedic disease affecting the lower extremities.
- History of lower extremity surgery.
- Body Mass Index (BMI) ≥ 30 kg/m².
研究計画
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Insole and Exercise Group
All participants in this group will receive custom 3D printed insoles and perform a short foot exercise program. |
The intervention consists of a combined biomechanical and active rehabilitation approach for individuals with pes planus:
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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 |
|---|---|---|
|
Foot Posture Index-6 (FPI-6)
時間枠：Baseline and 8 Weeks
|
Assesses foot posture across 6 criteria. Total scores range from -12 (highly supinated) to +12 (highly pronated). |
Baseline and 8 Weeks
|
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Navicular Drop Test (NDT)
時間枠：Baseline and 8 Weeks
|
Assesses medial longitudinal arch height difference (in mm) between seated (non-weight bearing) and standing (weight bearing) positions. Higher values indicate increased pronation. |
Baseline and 8 Weeks
|
|
Modified Star Excursion Balance Test (MSEBT)
時間枠：Baseline and 8 Weeks
|
Evaluates dynamic balance by measuring the maximum reach distance (in cm) in three directions: anterior, posteromedial, and posterolateral. |
Baseline and 8 Weeks
|
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Spatiotemporal Gait and Plantar Pressure Parameters
時間枠：Baseline and 8 Weeks
|
Evaluated using the Zebris system. Includes gait speed (m/s), cadence (steps/min), stride length (cm), stance percentage (%), and plantar pressure parameters (e.g., peak pressure, contact area). |
Baseline and 8 Weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
時間枠：Baseline and 8 Weeks
|
Assesses pain intensity on an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). |
Baseline and 8 Weeks
|
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36-Item Short Form Health Survey (SF-36)
時間枠：Baseline and 8 Weeks
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Assesses health-related quality of life across 8 domains. Subscale scores are transformed to a 0 to 100 scale, where higher scores indicate better health status. |
Baseline and 8 Weeks
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6-Minute Walk Test (6MWT) and Modified Borg Scale
時間枠：Baseline and 8 Weeks
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Evaluates functional capacity by measuring the total distance walked in 6 minutes (in meters). Perceived exertion is assessed before and after the test using the Modified Borg Scale (0-10 scale; higher scores indicate greater exertion). |
Baseline and 8 Weeks
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協力者と研究者
捜査官
- 主任研究者：Emrah Afsar, Phd、Kutahya Health Science University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。