Neurorehabilitation on Upper Limb and on Fatigue in Multiple Sclerosis
Effects of Neurorehabilitation on Upper Limb Performance and on Fatigue in People With Multiple Sclerosis
In Multiple Sclerosis the multiplicity of physical and psychological dysfunctions have been shown to exhibit a number of life-altering problems such as fatigue, limb weakness, alteration of upper extremity fine motor coordination, loss of sensation, spasticity. These problems affect performance of many daily living activities (ADL) such as dressing, bathing, self-care, and writing, thus reducing functional independence and self-rated quality of life.
Twenty people with Multiple Sclerosis will receive neurorehabilitation treatment comprising a combination of aerobic training and upper limb task-oriented training.
The aim of this pilot crossover study is to evaluate the effects of neurorehabilitation on upper limb performance and on fatigue in People with Multiple Sclerosis.
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
研究場所
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Milan、イタリア、20148
- Fondazione Don Gnocchi ONLUS
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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:
- Diagnosis of Multiple Sclerosis
- no relapses in the last three months
- Expanded Disability Status Scale (EDSS) ≤ 8;
Exclusion Criteria:
- subjects with relapses
- worsening of the pathology in the last three months
- subjects with cognitive and psychiatric disturbances
- subjects with cardiovascular disease
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：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：Neurorehabilitation
Participants in the experimental group will receive 1 hour treatment comprising 30' of aerobic training on an ergometer and 30' of task-oriented training focused on uppper limb rehabilitation.
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Participants in the experimental group will receive 1 hour treatment comprising 30' of aerobic training and 30' of task-oriented training focused on uppper limb rehabilitation for 3 times a week for 20 sessions.
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介入なし：Baseline
No intervention is planned
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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 |
|---|---|
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Change from Baseline in 9-hole peg test at 2 and 4 months
時間枠：baseline, then participants were followed for the duration the outpatient treatment protocol, an average of 8 weeks, and at follow up 2 months after the end of the treatment protocol
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baseline, then participants were followed for the duration the outpatient treatment protocol, an average of 8 weeks, and at follow up 2 months after the end of the treatment protocol
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Change from Baseline in Heart Rate at 2 and 4 months
時間枠：baseline, then participants were followed for the duration the outpatient treatment protocol, an average of 8 weeks, and at follow up 2 months after the end of the treatment protocol
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baseline, then participants were followed for the duration the outpatient treatment protocol, an average of 8 weeks, and at follow up 2 months after the end of the treatment protocol
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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
一次修了 (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 (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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- UL_SM
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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。