Effect of Pre-op Patient Education on Functional Outcomes After TKA
Effect of Pre-operative Patient Education Program on Functional Outcomes After Total Knee Arthroplasty
調査の概要
詳細な説明
The study will be developed in the dependencies of the Laboratory of Biomechanics of the Center for Health Sciences and Sports of UDESC. In the preoperative period the subjects will be informed about their physical conditions as well as signs and symptoms of the postoperative period. One group (GI) will receive this information verbally and one leaflet while the other group (GC) will receive only verbal information. The allocation in these groups will be through a lottery, carried out by a member of the team who will not participate in the evaluation stages.
This staff member will read the booklet individually for each GI participant, in a reserved room, before handing out the leaflet to take home. GI participants will be encouraged to reread the information in the home environment and will be asked about the completion of this in the following steps by the staff member responsible for the blinding.
All participants included in the study will perform the kinematic, kinetic and electromyographic gait analysis as well as evaluation of fear of movement, functional mobility and self-perceived functionality in the pre (baseline)-and postoperative period (6 weeks and after 6 months).
The total duration of each evaluation will be approximately 2 (two) hours and 30 (thirty) minutes and all collections will be carried out by the same team. The participant will be allowed to stop the test if they feel pain or become fatigued.
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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-
Santa Catarina
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Florianópolis、Santa Catarina、ブラジル、88080350
- Center for Health and Sport 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:
- Literate;
- Elective submission of unilateral total knee arthroplasty (TKA) due to osteoarthrosis
- Individuals without other arthroplasties in the lower limb in the last 6 months;
- Range of motion greater than 90 degrees or operated contralateral knee.
Exclusion Criteria:
- Associated condition that impedes performance in gait tests, including significant osteoarthrosis in the contralateral knee or hips (defined as pain greater than or equal to 5 on the analog visual pain scale);
- Absence or abandonment in the study follow-up sessions.
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：支持療法
- 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 |
|---|---|
|
実験的：Patient education program
Pre-operative education and pos-operative rehabilitation in individuals will be undergo knee arthroplasty.
|
Verbal and booklet about symptoms and physical conditions pos knee replacement
他の名前：
Physical therapy treatment
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アクティブコンパレータ：Control - only pos-op rehabilitation
Pos-operative rehabilitation in individuals will be undergo knee arthroplasty.
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Physical therapy treatment
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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 |
|---|---|---|
|
Timed up And Go Test score
時間枠：pre-operative; 6 weeks; 6 months
|
The timed up and go requires a patient to rise from a chair walk three meters around a piece of tape and return to the chair again as quickly as possible.
The TUG has good inter-rater and intra-rater reliability and validity for functional testing in older adults at risk for falls.
The test is easy to administer and can be completed in two to three minutes.Change from baseline (pre-operative) in the functional mobility.
The variable will be measured in seconds.
|
pre-operative; 6 weeks; 6 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 |
|---|---|---|
|
EMG activity
時間枠：pre-operative; 6 weeks; 6 months
|
Electromyographic activity of rectus femoris, vastus lateralis, vastus medialis, vastus medial and gastrocnemius by NORAXON WIRELESS EMG.
Change from baseline (pre-operative).The variable will be measured in % of maximal voluntary contraction.
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pre-operative; 6 weeks; 6 months
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Kinematics
時間枠：pre-operative; 6 weeks; 6 months
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Gait analysis by VICON three-dimensional ,10-camera motion capture system.The outcome measurement is assessed at pre-operation, six weeks and six month after operation.
Change from baseline (pre-operative).
The variable will be measured in degrees.
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pre-operative; 6 weeks; 6 months
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Kinetics
時間枠：pre-operative; 6 weeks; 6 months
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Gait analysis by AMTI plate force.
The outcome measurement is assessed at pre-operation, six weeks and six month after operation.
Change from baseline (pre-operative).
The variable will be measured in newtons
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pre-operative; 6 weeks; 6 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 |
|---|---|---|
|
kinesiophobia
時間枠：pre-operative; 6 weeks; 6 months
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Fear of movement.
The variable will be measured in points (score).
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pre-operative; 6 weeks; 6 months
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協力者と研究者
捜査官
- 主任研究者：Gilmar M Santos, PhD、University of State of Santa Catarina
研究記録日
主要日程の研究
研究開始 (実際)
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 (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。
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