Knee Stability Training for Knee Osteoarthritis (OA)
Knee Stability Training in Individuals With Knee Osteoarthritis
People with knee osteoarthritis (OA) frequently complain of knee instability. This study will test whether certain exercises can improve knee stability, reduce pain, and improve physical function in people with knee OA.
Study hypotheses: 1) Participants in the stability training group will demonstrate less pain and higher levels of physical function, based on self-report measures of pain and function (WOMAC, Lower Extremity Function Scale), and less time to complete the Get Up and Go test, a physical performance measure of function. 2) During walking and the step down task, participants in the stability training group will demonstrate greater knee motion during weight bearing, greater vertical ground reaction forces and loading rates, and reduced ratios of co-contraction between quadriceps/hamsting and tibialis anterior/gastrocnemius muscle pairs compared to the standard group. Participants in the stability group will also demonstrate greater step lengths, single limb support times, and average walking velocity compared to the standard group.
調査の概要
状態
詳細な説明
Traditional exercise therapy for knee OA primarily focuses on lower limb strength and joint motion deficits. Recent evidence has suggested that changes in lower limb biomechanical factors during weight bearing activities may have substantial impact on physical function and disease progression in individuals with knee OA. The effectiveness of exercise therapy programs might be improved by incorporating balance and agility training techniques (knee stability training). The aim of this trial is to test the effectiveness of supplementing traditional exercise therapy with knee stability training techniques tailored for individuals with knee OA.
Participants will be randomly assigned to one of two groups. The first group will participate in a standard rehabilitation program of traditional exercise therapy for knee OA. The second group will participate in a standard rehabilitation program supplemented with a knee stability program. Study visits will occur at study entry, 2 months, 6 months, and 1 year. At each study visit, changes in pain, physical function, and biomechanical factors will be assessed. This study will last for one year.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15260
- University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences
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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:
- Meet the 1986 American College of Rheumatology (ACR) clinical criteria for knee osteoarthritis
- Grade II or greater Kellgren and Lawrence radiographic changes
Exclusion Criteria:
- History of two or more falls within the year prior to study entry
- Unable to walk a distance of 100 feet without an assistive device or a rest period
- Total knee arthroplasty
- Uncontrolled hypertension
- History of cardiovascular disease
- History of neurological disorders that affect lower extremity function such as stroke or peripheral neuropathy
- Corticosteroid injection to the quadriceps or patellar tendon in the past month, or 3 or more within the past year
- Quadriceps tendon rupture, patellar tendon rupture, or patellar fracture that could place them at risk of re-injury during quadriceps strength testing
- Pregnancy
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：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 |
|---|---|
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実験的：1
Traditional exercise program supplemented with knee stability training activities
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The addition of agility and perturbation training techniques to the traditional exercise program
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アクティブコンパレータ：2
Traditional exercise program
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Exercises include stretching, strengthening, and aerobic exercise
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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 |
時間枠 |
|---|---|
|
Western Ontario and McMaster OA index (WOMAC)
時間枠：Measured at baseline, 2 months, 6 months, 1 year
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Measured at baseline, 2 months, 6 months, 1 year
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Lower Extremity Function Scale
時間枠：Measured at baseline, 2 months, 6 months, 1 year
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Measured at baseline, 2 months, 6 months, 1 year
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Get Up and Go test (a physical performance measure of function)
時間枠：Measured at baseline, 2 months, 6 months
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Measured at baseline, 2 months, 6 months
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Knee Outcome Survey - Activities of Daily Living Scale
時間枠：Measured at baseline, 2 months, 6 months, 1 year
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Measured at baseline, 2 months, 6 months, 1 year
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Cartilage morphology changes as measured by MRI
時間枠：Measured at baseline, 1 year
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Measured at baseline, 1 year
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Physical Activity Scale for the Elderly
時間枠：Measured at baseline, 2 months, 6 months, 1 year
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Measured at baseline, 2 months, 6 months, 1 year
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Quadriceps strength and activation
時間枠：Measured at baseline, 2 months, 6 months
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Measured at baseline, 2 months, 6 months
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Radiographic severity of OA
時間枠：Measured at baseline, 1 year
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Measured at baseline, 1 year
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Fear Avoidance questionnaire for the knee
時間枠：Measured at baseline, 2months, 6 months, 1 year
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Measured at baseline, 2months, 6 months, 1 year
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Beck Anxiety Index
時間枠：Measured at baseline, 2 months, 6 months, 1 year
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Measured at baseline, 2 months, 6 months, 1 year
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Center for Epidemiological Studies Depression Scale
時間枠：Measured at baseline, 2 months, 6 months, 1 year
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Measured at baseline, 2 months, 6 months, 1 year
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Motion analysis variables (knee motion, vertical ground reaction force, loading rates, knee adduction/abduction moment, and lower extremity muscle co-contractions during walking and a step-down task)
時間枠：Measured at baseline, 2 months, 6 months
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Measured at baseline, 2 months, 6 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：G. Kelley Fitzgerald, PhD, PT、University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences
出版物と役立つリンク
一般刊行物
- Fitzgerald GK, White DK, Piva SR. Associations for change in physical and psychological factors and treatment response following exercise in knee osteoarthritis: an exploratory study. Arthritis Care Res (Hoboken). 2012 Nov;64(11):1673-80. doi: 10.1002/acr.21751.
- Teixeira PE, Piva SR, Fitzgerald GK. Effects of impairment-based exercise on performance of specific self-reported functional tasks in individuals with knee osteoarthritis. Phys Ther. 2011 Dec;91(12):1752-65. doi: 10.2522/ptj.20100269. Epub 2011 Oct 14.
- Fitzgerald GK, Piva SR, Gil AB, Wisniewski SR, Oddis CV, Irrgang JJ. Agility and perturbation training techniques in exercise therapy for reducing pain and improving function in people with knee osteoarthritis: a randomized clinical trial. Phys Ther. 2011 Apr;91(4):452-69. doi: 10.2522/ptj.20100188. Epub 2011 Feb 17.
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。