Comparison Between Palpatory and Ultrasound-guided Methods for Botulinum Toxin Administration in Spastic Paraplegia
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Bruna de Oliveira, MD
- 電話番号：5521999200801
- メール：b_andrade@id.uff.br
研究場所
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Rio de Janeiro
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Rio de Janeiro、Rio de Janeiro、ブラジル、22290-140
- 募集
- Instituto de Neurologia Deolindo Couto
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コンタクト：
- Bruna de Oliveira
- 電話番号：5521999200801
- メール：b_andrade@id.uff.br
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria
- Age over 18 years
- Clinical diagnosis of spastic paraplegia
- Spasticity with Ashworth Scale score between 2 and 3 in at least one muscle group with indication for botulinum toxin treatment
- Muscle strength ≥ 3 on the Muscle Strength Assessment Scale
- Enrollment in a rehabilitation program
- For women of childbearing potential, a negative beta-hCG test at the time of injection
Exclusion Criteria
- Concomitant neuromuscular disorders
- History of hypersensitivity to botulinum toxin
- Active infection at the injection site
- Ashworth Scale score of 4
- Pregnancy or breastfeeding
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：Spastic Paraplegia Cohort (Anatomical Toxin Injection followed by USG-Guided Injection)
Participants with spastic paraplegia receive two sequential treatments separated by a 16-week washout period: First intervention: AbobotulinumtoxinA injection using the conventional anatomical/palpation technique. Washout period: 16 weeks. Second intervention: AbobotulinumtoxinA injection using the ultrasound-guided technique |
Administration of AbobotulinumtoxinA (500U) into spastic lower limb target muscles under real-time ultrasound guidance to ensure precise muscle localization.
Performed 16 weeks after the first intervention.
Assessments are performed pre-injection and 4 weeks post-injection
Administration of AbobotulinumtoxinA (500U) into spastic lower limb target muscles using standard anatomical landmarks and manual palpation.
Assessments are performed at baseline and 4 weeks post-injection.
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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 spasticity after BoNT-A injection techniques
時間枠：Baseline and 4 weeks after each injection session
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Change in spasticity measured by the Modified Ashworth Scale (MAS), comparing conventional landmark-guided versus ultrasound-guided botulinum toxin type A injections in patients with spastic paraplegia.
The Modified Ashworth Scale ranges from 0 to 4, with higher scores indicating greater muscle tone/spasticity (worse outcome)
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Baseline and 4 weeks after each injection session
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Functional improvement assessed by Goal Attainment Scaling
時間枠：Baseline and 4 weeks after each intervention
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Functional improvement assessed by Goal Attainment Scaling (GAS) after conventional landmark-guided versus ultrasound-guided botulinum toxin type A injections. The Goal Attainment Scaling score ranges from -2 to +2, with higher scores indicating greater achievement of the predefined treatment goals (better outcome) |
Baseline and 4 weeks after each intervention
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Functional mobility assessed by the Timed Up and Go Test
時間枠：Baseline and 4 weeks after each intervention
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Change in functional mobility measured by the Timed Up and Go (TUG) Test, comparing conventional landmark-guided versus ultrasound-guided botulinum toxin type A injections. The Timed Up and Go Test is measured in seconds, with lower times indicating better functional mobility (better outcome) |
Baseline and 4 weeks after each intervention
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Change in functional independence assessed by the Modified Barthel Index
時間枠：Baseline and 4 weeks after each intervention
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Change in functional independence measured by the Modified Barthel Index, comparing conventional landmark-guided versus ultrasound-guided botulinum toxin type A injections. The Modified Barthel Index ranges from 0 to 100, with higher scores indicating greater functional independence (better outcome). |
Baseline and 4 weeks after each intervention
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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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Pain intensity after BoNT-A injection techniques
時間枠：Baseline and 4 weeks after each intervention
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Change in pain intensity measured by the Visual Analog Scale (VAS).
The Visual Analog Scale ranges from 0 to 10, with higher scores indicating greater pain intensity (worse outcome)
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Baseline and 4 weeks after each intervention
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Quality of life after BoNT-A injection techniques
時間枠：Baseline and 4 weeks after each intervention
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Change in quality of life assessed by the 36-Item Short Form Health Survey (SF-36). The SF-36 assesses eight health domains, with scores ranging from 0 to 100 for each domain. Higher scores indicate better health status (better outcome) |
Baseline and 4 weeks after each intervention
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Adverse events related to BoNT-A injection techniques
時間枠：Up to 16 weeks after each injection
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Incidence and severity of adverse events associated with conventional landmark-guided and ultrasound-guided botulinum toxin type A injections
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Up to 16 weeks after each injection
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協力者と研究者
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
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