Efficacy of Modified FUT Protocols in Relation to CR Protocol
2019年8月28日 更新者:Tamyris Padovani dos Santos、University of Sao Paulo
Efficacy of Modified FUT Protocols With 12 and 24 Hours of Upper Limb Immobilization in Relation to CR Arm Protocol.
There are some treatments after Stroke.
Among these, use forced therapy (FUT), which is based on overcoming learned disuse by reintroduction of the paretic upper limb in the performance of daily activities.
There are different protocols FUT to the daily time constraint, the number of days and even the type of constriction.
Researchers have developed a protocol using four weeks constriction, daily constriction 24 hours and with the free end of the weekends.
Because it is a restrictive therapy, which requires the use of one of the arms and on the other hand, this mode of treatment is open to criticism, however, despite the efficacy of the protocol, patients do not have good adhesion to the protocol for the constriction severe over time.
The objective of this work is to verify the safety of the developed protocol and analyze the feasibility of reducing the daily time of constriction 12 hours, with a new protocol movement constriction, easier to perform and more patient acceptance.
Participate in this study 82 individuals hemiparetic post Stroke, which will be recruited to Neurovascular Diseases Clinic and will be registered at the Rehabilitation Center of Integrated State Hospital.
Participants will be randomly divided into three groups: the FUT24 (non-paretic upper limb constriction 24 hours a day, five days a week for 4 weeks), the FUT 12 (non-paretic upper limb constriction for 12 hours a day, five days a week for 4 weeks) and CK (Classic Kinesiotherapy, at least 2 times a week for 4 weeks).
Will be held weekly and after the end of the monthly monitoring reviews protocols.
For the rating scales are use: National Institute of Health Stroke Scale, the Ashworth Scale, the Wolf Motor Function Test, the Motor Activity Log, Fugl-Meyer Assesment, dynamometry handgrip and surface electromyography (flexor and extensor muscles wrist).
The researchers hope that this protocol does not bring damage to the upper limb in constriction and it is established a new protocol FUT easier to perform and more acceptable to patients, allowing the use of this technique by health professionals.
調査の概要
詳細な説明
The constriction of the non-paretic upper limb will be conducted through a tubular mesh with UL positioned in adduction and shoulder internal rotation and elbow flexion greater than 90º in FUT 24 and FUT 12 groups.
Daily, the mesh is withdrawn by the investigators made hygienic, and the new constraint is accomplished using a new tubular mesh.The Classic Kinesiotherapy Group,which will receive as a treatment only kinesiotherapy.
研究の種類
介入
入学 (実際)
45
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
SP
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Ribeirão Preto、SP、ブラジル、14026514
- Tamyris Padovani dos Santos
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Good cognition,
- Absence of joint blocks,
- Good range of motion in upper limb with at least 20º of active extension of the wrist and 10º in the metacarpal phalangeal,
- Joint and walking capacity without assistance.
Exclusion Criteria:
- Heart arrhythmia,
- Hypertension,
- Severe cardiovascular and respiratory problems,
- Inability to attend the sessions.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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: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:Forced Use Therapy
Constriction (through the tubular mesh) of non paretic upper limb for a period of 12 and 24 hours, 5 days per week for 4 weeks.
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Rehabilitation in upper limb during and after applying of FUT (through the tubular mesh) post stroke.
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アクティブコンパレータ:Classical Kinesiotherapy
Rehabilitation of classical kinesiotherapy,at least 2 times a week for 4 weeks.
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Applying classical kinesiotherapy in upper limb post stroke.
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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 |
|---|---|---|
|
Evaluation of RMS activity through surface electromyography.
時間枠:4 months
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Evaluations shall be performed weekly during the treatment period and 1 monthly assessment for 3 months after the protocol without therapeutic intervention.
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4 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 |
|---|---|---|
|
Evaluate the strength handgrip (Kgf) of hemiparetic patients submitted to FUT post stroke.
時間枠:4 months
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Evaluations shall be performed weekly during the treatment period and 1 monthly assessment for 3 months after the protocol without therapeutic intervention.
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4 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者:Tamyris Padovani dos Santos、University of Sao Paulo
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2016年8月1日
一次修了 (実際)
2017年5月1日
研究の完了 (実際)
2019年1月1日
試験登録日
最初に提出
2015年4月9日
QC基準を満たした最初の提出物
2015年5月7日
最初の投稿 (見積もり)
2015年5月12日
学習記録の更新
投稿された最後の更新 (実際)
2019年8月30日
QC基準を満たした最後の更新が送信されました
2019年8月28日
最終確認日
2019年8月1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。