Preventing Falls and Participation Restrictions in Neurological Diseases
Educational and Exercise Intervention to Prevent Falls and Participation Restrictions in Subjects With Neurological Diseases
調査の概要
詳細な説明
90 patients will be randomly patients will be stratified by disease type and randomized separately.
The trial will be organized in Baseline assessment (clinical characteristics; fall predictors, chosen among the variables found to predict falls in the observational study), experimental intervention (experimental group) vs. usual rehabilitation programs (control group) and assessment at end of treatment and six months after treatment.
The aim of the treatment will be the prevention of falls.
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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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:
Patients with stroke, Parkinson's disease and Multiple Sclerosis residing in the centers' catchment areas, requiring rehabilitation, and releasing a written informed consent.
Exclusion Criteria:
1. Cognitive impairment (Minimental State Examination score <21); 2. Major depression; 3. Severe joint/bone disorder interfering with mobility, 4. Aphasia if interfering with understanding the aims of the study and self-administered tests; 5. relapses in the previous three months (MS); 6. Stroke occurred in least four weeks before study entry.
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：Experimental group: Education group
Participants in the experimental intervention group (education group) received an educational program and tailored home exercises.
This intervention consist of multiple, interacting components supported by a handbook and audio-video material designed to teach people the skills, techniques, and strategies for preventing falls, and increase social participation and engagement in inactivity of daily living. .
After the educational session, two one hour sessions were spent to teach safe balance exercises that were developed in preceding studies, the patient was invited to perform at home for 2 months.
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Participants in the experimental intervention group received an educational program and tailored home exercises.
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アクティブコンパレータ：Control Group: Usual care
Participants allocated to the control group received ongoing usual treatments.
In addition, two one hour lessons were spent to teach stretching exercises that the patient was invited to perform at home for 2 months.
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Participants allocated to the control group received stretching exercises.
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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 of Percentage of fallers
時間枠：Change from Baseline percentage of fallers at 6 months.
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Each patient was given a fall diary and was followed for six months with telephone contacts for six months.
The patient (or, if unavailable, the spouse or an informed caregiver) was inquired on targeted rehabilitation programs received during the follow up, the use of walking aid and any incurred falls, with date, circumstances, underlying cause and related injuries.
A fall was defined as an unexpected event where the person inadvertently came to rest on the ground or other lower level subjects with >1 falls in the 6 months follow up were categorized as "faller".
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Change from Baseline percentage of fallers at 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 |
|---|---|---|
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Change of Participation level
時間枠：Change from Baseline partecipation at 6 months.
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The patient (or, if unavailable, the spouse or an informed caregiver) was inquired on partecipation level.
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Change from Baseline partecipation at 6 months.
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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 (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。