足の健康を通じて自律性を保つ：高齢者向けのさまざまなワークショップを含むプログラムの受容性に関する研究 (MINIPAS)
Préserver Son Autonomie Par la santé du Pied : Etude d'acceptabilité d'un Program Incluant différents Ateliers Chez Les personnes âgées
Every year in France, 2 million falls by people over 65 are responsible for 10,000 deaths, the leading cause of accidental death, and more than 130,000 hospitalizations.
The investigators will combine minimalist footwear, plantar massage, and workshops to re-learn walking and posture. The main objective of this study is to verify the acceptability and feasibility of this program among the elderly.
調査の概要
状態
条件
詳細な説明
Study participants will benefit from a plantar massage session (5-10 min massage performed by a podiatrist) and one posture and walking workshop per week, also supervised by the podiatrist. Minimalist shoes have been purchased by the centers and used during the workshops. They will also be available to participants outside the workshops for the duration of the study.
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
-
-
-
Beaulieu、フランス、43800
- EHPAD "Foyer Notre-Dame"
-
Brives-Charensac、フランス、43700
- EHPAD "Vert-Bocage"
-
Le Puy-en-Velay、フランス、43000
- Ehpad Nazareth
-
Le Puy-en-Velay、フランス、43000
- Ssiad " Amadom43 "
-
Vals-près-le-Puy、フランス、43750
- EHPAD Foyer " Saint-Dominique "
-
-
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:
- People over 65 years of age
- Able to walk independently with or without a walking aid (cane, walker, etc.)
- Persons affiliated with a social security system or assimilated
- Persons (participants, guardians, or curators where applicable) who have been informed and have given their written consent to participate in the study.
Exclusion Criteria:
- People with a contraindication to wearing minimalist shoes
- Persons unable to participate in the various workshops
- Refusal to participate in research
- Persons under court protection
- Persons unable to walk
- Persons with any other contraindication at the investigator's discretion
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：支持療法
- 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 |
|---|---|
|
実験的：Workshops aiming to preserve elderly's autonomy through foot health
Study participants will benefit from a plantar massage session (5-10 min foot massage) and one posture and walking workshop per week, supervised by a trained health professional. Minimalist shoes have been purchased by the centers and used during the workshops. They will also be available to participants outside the workshops for the duration of the study. |
Combination of minimalist footwear, foot massages, and workshops to re-learn walking and posture |
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 |
|---|---|---|
|
The acceptability of foot health workshops conducted by a nurse with elderly people
時間枠：At the end of the 12 weeks program
|
Participant acceptability will be assessed by workshop attendance rates. |
At the end of the 12 weeks program
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
足の疾患の数と種類
時間枠：介入前と介入直後
|
介入前と介入直後
|
|
|
靴の使用時間数
時間枠：介入直後
|
介入直後
|
|
|
Foot Length measurement
時間枠：Before and immediately after the intervention
|
In centimeters (cm) |
Before and immediately after the intervention
|
|
The distance of the center of gravity from the center
時間枠：Before and immediately after the intervention
|
Thanks to the stabilometry platform |
Before and immediately after the intervention
|
|
Measurement of bearing surface and force distribution in static position
時間枠：Before and immediately after the intervention
|
Thanks to the stabilometry platform |
Before and immediately after the intervention
|
|
Joint capacity for ankle flexion and extension
時間枠：Before and immediately after the intervention
|
Measured by the Weight-Bearing Lunge Test |
Before and immediately after the intervention
|
|
Fear of falling scale
時間枠：Before and immediately after the intervention
|
Numerical scale from 0 to 10 (0 meaning no fear and 10 the worst fear imaginable) |
Before and immediately after the intervention
|
|
The risk of falling
時間枠：Before and immediately after the intervention
|
Timed up and go test |
Before and immediately after the intervention
|
|
Foot pain scale
時間枠：Before and immediately after the intervention
|
Numerical scale from 0 to 10 (0 meaning no pain and 10 the worst pain imaginable) |
Before and immediately after the intervention
|
|
A specifically made satisfaction questionnaire
時間枠：Immediately after the intervention
|
To evaluate participants' perception of the minimalist footwear and the various workshops (foot massage and walking) |
Immediately after the intervention
|
協力者と研究者
出版物と役立つリンク
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
本研究に関する用語
その他の研究ID番号
- RIPH2-FUNDENBERGER-MINIPAS
- 2024-A00086-41 (その他の識別子：ID-RCB)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。