Feasibility of ESWT Treatment in Post-stroke Patients With Triceps Sural Spasticity (Waves2021)
ESWT Treatment in Post-stroke Patients With Triceps Sural: a Feasibility RCT
The main objective is to evaluate the feasibility of two different rehabilitation protocols that differed from the number of treatment sessions (1 session of ESWT versus 3 weekly sessions of ESWT), in patients with triceps surae spasticity after stroke. In both arms the other ESWT parameters (types of ESWT, intensity, frequency, location) and stretching sessions are the same.
Secondary objectives: to compare functional performances in these two groups of patients receiving the different rehabilitation protocol with ESWT, using the following parameters:
- Six Minutes walking test (6MWT) ; - Time Up & Go (TUG); - Modified Ashworth scale (MAS); - Lower Extremity Functional Scale (LEFS); - passive ankle range of motion (p-ROM), pain (NRS); and presence of ankle clonus. These parameters are assessed during baseline (T0), after 4 weeks (T1) and after 12 weeks (T2).
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Stefania Testoni, Dr
- 電話番号：+39 0522296163
- メール：stefania.testoni@ausl.re.it
研究場所
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Emilia Romagna
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Reggio Emilia、Emilia Romagna、イタリア、42123
- 募集
- Operational Unit of Physical Medicine and Rehabilitation AUSL - IRCCS Reggio Emilia
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コンタクト：
- Stefania Testoni, Dr
- 電話番号：+39 0522296163
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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:
- Adult patients of legal age
- Time elapsed since the stroke between 6 and 60 months
- Autonomous or supervised walking with or without aids
- Spasticity of the sural triceps> 1 on the MAS scale
Exclusion Criteria:
- Joint stiffness of the lower limbs due to other pathologies (ex orthopedic or rheumatological);
- Conditions that interfere with evaluation or collaboration in rehabilitation treatment (major psychiatric illnesses, clearly detectable cognitive deficits, severe pre-existing disabilities, sensory disturbances, etc.)
- Focal antispasmodic toxin treatments in the previous 3 months or phenolic blocks in the previous 9 months in the treatment region
- Treatments with central antispasmodic drugs with dosage modifications in the last week of starting treatment
- Individual neurorehabilitation treatments in progress
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：独身
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：グループⅠ
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3 weeks intervention:
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偽コンパレータ：Group II
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3 weeks intervention:
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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 |
|---|---|---|
|
Feasibility of two kind treatments proposed
時間枠：T1 after 4 weeks from T0 (Enrollment)
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The intervention is feasible if at least 80% of the enrolled patients complete the entire treatment foreseen in the allocation group
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T1 after 4 weeks from T0 (Enrollment)
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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 Walking Resistance
時間枠：T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
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6 minute walking test
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T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
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Change in Level of mobility and balance
時間枠：T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
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Timed Up & Go Test
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T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
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Change in spasticity
時間枠：T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
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Modified Ashworth Scale (MAS).
Score from 0 to 4, higher scores mean a worse outcome
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T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
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Change in Passive ROM of the ankle in dorsiflexion
時間枠：T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
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Passive ankle Range of Motion (p-ROM)
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T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
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Change in Leg Pain
時間枠：T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
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Numeric Pain Rating Scale (NPRS) Score from 0 to 10, higher scores mean a worse outcome
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T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
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Change in Ability to carry out activities of daily living
時間枠：T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
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Lower Extremity Functional Scale (LEFS).
Score from 0 to 80, higher scores mean a better outcome.
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T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
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Change in triceps clones
時間枠：T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
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Presence of ankle clonus
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T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
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協力者と研究者
捜査官
- 主任研究者：Stefania Testoni, Dr、Azienda AUSLRE
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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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ESWT + Stretchingの臨床試験
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Afyonkarahisar Health Sciences University完了
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Grzegorz FojeckiUniversity of Southern Denmark; Region of Southern Denmark完了