Shoe Orthotics for Improvement of Biomechanics and Symptoms of Knee Osteoarthritis
Combined Medial and Lateral Orthotics for the Treatment of Knee Osteoarthritis
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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British Columbia
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Vancouver、British Columbia、カナダ
- University of British Columbia; University Hospital
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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:
i) age 50 - 80 years (to meet the American College of Rheumatology clinical definition of OA)
ii) medial tibiofemoral OA, defined as medial knee pain on most days of the past month and evidence on radiographs of a definite osteophyte in the medial tibiofemoral compartment
iii) pronated feet, defined as a foot posture index that is 0.5 standard deviations above the reported population mean.
Exclusion Criteria:
i) low pain score on a numerical rating scale of pain (average knee pain on walking ≤3 out of 10 over previous week) to allow detection of treatment response
ii) knee surgery or intra-articular corticosteroid injection within the previous six months
iii) current or recent (within 4 weeks) oral corticosteroid use
iv) any muscular, joint or neurological condition affecting lower limb within the past 6 months
v) ankle/foot pathology or pain that precludes the use of orthotics
vi) current use of foot orthotics
vii) use of footwear unable to accommodate an orthotic
viii) unable to walk without a gait aid
ix) inability to speak English or have a family member present to translate (required for the validity of the questionnaires)
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：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：ダブル
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：Lateral wedge plus medial arch support
The lateral wedge plus medial support orthotic will be custom-made and designed using a 3D volumetric cast of the foot with the participant's foot in a subtalar joint neutral position.
The cast will be balanced so that it rests in a neutral position then smoothed to address any irregularities and to allow for soft tissue splay.
Polypropylene sheets of 3mm or 4mm thickness will be vacuum formed or milled directly to produce a ¾ length shell.
An ethyl-vinyl-acetone (EVA) lateral post in the heel and forefoot of 5 degrees will be incorporated into the orthotic.
The orthotic will be finished with a neoprene cover for improved comfort and patient compliance.
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This will be a randomized cross-over study where all participants will receive both orthoses over a six month period.
Each intervention will last two months, separated by a two month washout period of no orthotics wear, and will be preceded and followed by a laboratory-based gait and pain assessment.
Two months has been chosen as the ideal time frame to ensure maximum participant adherence, to observe clinically meaningful changes in symptoms, and to minimize degradation of the insoles.
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実験的：Lateral wedge
The lateral wedge only orthotic will be constructed of EVA, made to full length of the subject's footwear and incorporate a 5 degree posting.
The wedge will be finished with a neoprene cover for improved comfort and patient compliance.
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This will be a randomized cross-over study where all participants will receive both orthoses over a six month period.
Each intervention will last two months, separated by a two month washout period of no orthotics wear, and will be preceded and followed by a laboratory-based gait and pain assessment.
Two months has been chosen as the ideal time frame to ensure maximum participant adherence, to observe clinically meaningful changes in symptoms, and to minimize degradation of the insoles.
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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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Change in knee joint load during walking: knee adduction moment
時間枠：Baseline and 2 months
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Participants will undergo three-dimensional gait analysis. This will be performed barefoot with and without the orthotics (conditions tested in a random order). Kinematic and kinetic data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. Participants will be instructed to walk at a self-selected walking speed measured using photoelectric timing gates and placed along the walkway two metres on either side of the force platforms (note that walking speed during follow-up assessments will be kept similar (+/- 5%) to that chosen by each participant at baseline). A total of five trials will be collected. The primary loading variable will be the KAM impulse - defined as the area under the KAM curve. Rather than a single peak value, the KAM impulse is more reflective of load experienced over the duration of stance and reflects the cumulative loading experienced at the knee during walking. |
Baseline and 2 months
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Change in Knee Pain
時間枠：Baseline and 2 Months
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The WOMAC is a disease-specific questionnaire that quantifies self-reported joint pain, joint stiffness, and physical function.
It is a valid, reliable, and responsive outcome measure that is recommended for use in osteoarthritis clinical trials.
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Baseline and 2 Months
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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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Change in Self-Reported Physical Function
時間枠：Baseline and 2 Months
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The physical function subscale (17 questions) on the WOMAC will be used.
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Baseline and 2 Months
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Change in Foot Pain
時間枠：Baseline and 2 Months
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Participants will rate their perceived foot function and pain using the Foot Function Index (revised - short form).
This is a self-report questionnaire which consists of 34 items and provides the ability to quantify aspects of pain, disability and activity limitation.
Such assessment of pain has been widely used and is a valid and reliable method in clinical research studies
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Baseline and 2 Months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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Participant perceived response to treatment
時間枠：2 Months
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At follow-up for each orthotic, participants will rate overall perceived change in pain and physical function (vs.
baseline) on an ordinal scale (1-much worse, 2-slightly worse, 3-same, 4-slightly better, 5-much better).
This will be dichotomized into 'improvement' (4 and 5) or 'no improvement'
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2 Months
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協力者と研究者
捜査官
- 主任研究者：Michael A Hunt, PhD, PT、University of British Columbia
出版物と役立つリンク
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。