Outcomes of Compliance With Brace Wear in Clubfoot
Measurement of Compliance in Clubfoot Bracing Via a Novel Pressure Sensor
It has been shown that compliance with brace wear can significantly improve the treatment outcome of idiopathic clubfoot deformities. Noncompliance rates have been estimated to be around 30-41% with initial orthosis wear after successful treatment with serial castings. These studies have depended on family logs and not objective data. With the development of a monitoring device, this study hopes to examine: (1) actual patient compliance, (2) comparisons of actual wear time and assumed wear time and (3) the relationship of patient wear with clinical outcomes.
Hypothesis:
Actual patient compliance in foot abduction orthoses (FAO) wear is less than self-reported compliance and noncompliance is correlated to future surgeries.
調査の概要
状態
条件
詳細な説明
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Kentucky
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Lexington、Kentucky、アメリカ、40502
- Shriners Hospital for Children
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Unilateral or bilateral clubfoot
- Birth to 3 years of age
- Has been successfully treated with Ponseti casting protocol
Exclusion Criteria:
- Any other prior treatment for clubfoot
- Other existing diagnoses or conditions
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
コホートと介入
グループ/コホート |
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Functioning Pressure Sensor Group
This group will have a functioning pressure sensor placed on the foot ankle orthosis.
The group will be blinded as to whether or not the sensor is functioning.
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Non-Functioning Pressure Sensor Group
This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis.
The group will be blinded as to whether or not the sensor is functioning.
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No Sensor Group
This group will not have a pressure sensor placed on the foot ankle orthosis.
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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 |
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Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours)
時間枠:3 months
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Number of hours per day in brace will be measured by pressure sensor at the end of month 1, month 2 and month 3. Parent report of brace wear will also be documented at each of these timepoints.
Wear rate percentage will be calculated by dividing the number of hours of brace wear (either actual as measured by the sensor or reported by parent diary) by the recommended 24 hours.
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3 months
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協力者と研究者
捜査官
- 主任研究者:Todd A Milbrandt, MD、Shriners Hospital for Children
出版物と役立つリンク
一般刊行物
- Thacker MM, Scher DM, Sala DA, van Bosse HJ, Feldman DS, Lehman WB. Use of the foot abduction orthosis following Ponseti casts: is it essential? J Pediatr Orthop. 2005 Mar-Apr;25(2):225-8. doi: 10.1097/01.bpo.0000150814.56790.f9.
- Dobbs MB, Morcuende JA, Gurnett CA, Ponseti IV. Treatment of idiopathic clubfoot: an historical review. Iowa Orthop J. 2000;20:59-64.
- Dobbs MB, Rudzki JR, Purcell DB, Walton T, Porter KR, Gurnett CA. Factors predictive of outcome after use of the Ponseti method for the treatment of idiopathic clubfeet. J Bone Joint Surg Am. 2004 Jan;86(1):22-7. doi: 10.2106/00004623-200401000-00005.
- Haft GF, Walker CG, Crawford HA. Early clubfoot recurrence after use of the Ponseti method in a New Zealand population. J Bone Joint Surg Am. 2007 Mar;89(3):487-93. doi: 10.2106/JBJS.F.00169.
- Changulani M, Garg NK, Rajagopal TS, Bass A, Nayagam SN, Sampath J, Bruce CE. Treatment of idiopathic club foot using the Ponseti method. Initial experience. J Bone Joint Surg Br. 2006 Oct;88(10):1385-7. doi: 10.1302/0301-620X.88B10.17578.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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。