Mobile and Remote Monitoring of Seating Pressure for Wheelchair Users With SCI
2019年6月13日 更新者：Melissa M. Morrow, Ph.D.、Mayo Clinic
This study will examine two interventions to increase weight shifts, overall trunk movement, and self-efficacy related to pressure ulcer prevention in wheelchair users with a spinal cord injury (SCI).
調査の概要
状態
完了
条件
詳細な説明
Participants will use a mobile seat interface pressure mapping system that gives them live, real-time, visual feedback on the distribution of pressure between them and their seat cushion. This type of feedback works as a compensatory strategy for lack of sensation and allows the individual to visually observe pressure distribution they are not able to feel. Additionally, the participants will be provided with structured pressure ulcer prevention education, grounded in the principles of social cognitive theory, regarding pressure ulcer risk and use of weight shifts.
The pressure mapping system, which will be used during training, provides virtual modeling of the desired outcome (reduced pressure) and is an important part of the education module.
The findings of this study will inform clinicians and investigators of whether use of mobile seat interface pressure mapping as a compensatory-based intervention has a positive impact on trunk movement and self-efficacy for completing weight shifts in wheelchair users who lack sensation. Another contribution of this work is an exploration of the relationship between self-efficacy and movement in wheelchair users.
研究の種類
介入
入学 (実際)
19
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
-
-
Minnesota
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic
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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～80年 (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:
- Individuals with a spinal cord injury (C4 and below, traumatic or non-traumatic, with onset greater than 12 months at enrollment)
- Individuals who use a wheelchair as their primary form of mobility
- Individuals who are willing to participate and able to make 2 visits to the Mayo Clinic in Rochester, MN
Exclusion Criteria:
- Documented active pressure ulcer of any stage at initiation of study
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：防止
- 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 |
|---|---|
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他の：Intervention
Two interventions will be provided.
The first intervention is a structured education regarding pressure ulcer prevention through weight shifts at start of study.
The second intervention is the use of a mobile seat interface pressure map (IPM), which will occur during two intervention phases.
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Structured education for performance weight shift maneuvers and pressure ulcer prevention will occur during the initial visit for each subject.
The education method used aligns with principles of the social cognitive theory to facilitate learning.
The purpose in providing the education is to ensure all of the participants receive uniform instruction in how to perform weight shifts and to facilitate understanding of the importance of completing them as a protective measure against pressure ulcer development.
Because each participant will come into the study at varying levels of understanding about pressure ulcer risk and knowledge of how to complete weight shift maneuvers, the education component is critical to ensure all participants are provided with the same information in the same way.
This mobile IPM system was designed to provide visual information about seat interface pressure distribution to compensate for lack of sensation on the sitting surface.
This variable will be toggled on and off between the intervention and control phases of the study.
The participants will have access to the visual feedback while learning how to complete weight shift maneuvers at the initial visit and then again at home during the intervention phases (weeks 2 and 4).
During the control phases (weeks 1 and 3), they will not have access to the visual feedback from the pressure map
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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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Trunk Movement
時間枠：For each phase and session combination (A1, B1, A2, B2), the daily values will be averaged over the 7 day collection period for one representative daily percentage of trunk active movement.
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The primary outcome variable, trunk movement, will be defined by the percentage of the day with active trunk movement.
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For each phase and session combination (A1, B1, A2, B2), the daily values will be averaged over the 7 day collection period for one representative daily percentage of trunk active movement.
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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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Total Vector Magnitude of Movement
時間枠：For each phase and session combination (A1, B1, A2, B2), the daily values will be averaged over the 7 day collection period for one representative daily percentage of trunk active movement.
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The vector magnitude for each second of data during wear-times will be classified as a period of activity or inactivity.
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For each phase and session combination (A1, B1, A2, B2), the daily values will be averaged over the 7 day collection period for one representative daily percentage of trunk active movement.
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Forward and Lateral Tilt
時間枠：For each phase and session combination (A1, B1, A2, B2), the daily values will be averaged over the 7 day collection period for one representative daily percentage of trunk active movement.
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Forward and lateral tilt will be assessed with the raw triaxial accelerometer data by determining the angles between gravity and the off-axes
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For each phase and session combination (A1, B1, A2, B2), the daily values will be averaged over the 7 day collection period for one representative daily percentage of trunk active movement.
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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：Melissa MB Morrow, PhD、Mayo Clinic
- 主任研究者：Tamara L Vos-Draper, PhD、University of Minnesota
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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- Raghavan P, Raza WA, Ahmed YS, Chamberlain MA. Prevalence of pressure sores in a community sample of spinal injury patients. Clin Rehabil. 2003 Dec;17(8):879-84. doi: 10.1191/0269215503cr692oa.
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- Crawford SA, Strain B, Gregg B, Walsh DM, Porter-Armstrong AP. An investigation of the impact of the Force Sensing Array pressure mapping system on the clinical judgement of occupational therapists. Clin Rehabil. 2005 Mar;19(2):224-31. doi: 10.1191/0269215505cr826oa.
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便利なリンク
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 (実際)
2017年2月14日
一次修了 (実際)
2017年9月11日
研究の完了 (実際)
2017年9月11日
試験登録日
最初に提出
2019年6月11日
QC基準を満たした最初の提出物
2019年6月13日
最初の投稿 (実際)
2019年6月14日
学習記録の更新
投稿された最後の更新 (実際)
2019年6月14日
QC基準を満たした最後の更新が送信されました
2019年6月13日
最終確認日
2019年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 16-007531
- 1R21AG050640-01A1 (米国 NIH グラント/契約)
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?
いいえ
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
いいえ
米国FDA規制機器製品の研究
いいえ
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