Interactive Telehealth for Wheelchair Users
Interactive Telehealth and Auto-Biofeedback Sensor System for Individuals Who Use a Wheelchair: Phase II
調査の概要
状態
詳細な説明
Purpose: The purpose of this study is to evaluate the efficacy of an interactive tele-health monitoring and biofeedback system to establish healthy behaviors and promote self-management of pressure relief maneuvers and physical activity.
Procedures and Course of Study:
Baseline 50 participants will be enrolled. At study entry participants will complete four baseline questionnaires and have a Nurse Practitioner or Physician's Assistant inspect their ischial skin to ensure that their prior ulcer is fully healed. A pressure-sensing mat (PRESS) will be placed under their wheelchair cushion, and a wheelchair propulsion motion sensor (WAMS) will be placed on the rear wheel of their wheelchair. The PRESS and WAMS sensors will record participants' pressure relief and wheelchair propulsion activity for the next two weeks.
Intervention:
Participants will then return to the clinic and the study physical therapist will provide all participants with education on importance of pressure relief maneuvers and physical activity for health as well as training in the 3 styles of pressure relief (forward and side leans, depression raise) and shoulder strengthening exercises to protect against shoulder impingement and pain with increased pressure relief and wheelchair propulsion activity. The study physical therapist will then assist all participants in setting goals to increase pressure relief frequency and/or duration and wheelchair propulsion pushes for the future based on their baseline activity. Participants will be randomized into one of two groups: feedback and no feedback. In both groups pressure relief and wheelchair propulsion activity will be recorded by the PRESS and WAMS sensors for the 12 months. Those participants in the no-feedback group will have the feedback features of the system disabled. Those participants in the feedback group will receive instant visual feedback on pressure relief duration and daily summary charts for both pressure relief and wheelchair propulsion activities.
Follow-up:
Every month following the intervention for 12 months, a physical therapist will contact participants by phone to inquire whether their ischial skin integrity has changed and whether they have developed a pressure ulcer. Additionally, all participants will return to the clinic at 3, 6, 9, and 12 months after the intervention and a nurse practitioner will examine their ischial skin and review their medical records to determine if a pressure ulcer has developed. Participants will repeat the 4 questionnaires from the baseline evaluation at each follow-up visit. At the 12 month follow-up visit, participants will return the sensor equipment.
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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California
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Downey、California、アメリカ、90242
- Rancho Los Amigos National Rehabilitaiton Center
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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:
- paraplegia from Spinal Cord Injury
- a history of pressure ulcer that has healed or 6 months post surgical repair
- use a manual wheelchair for mobility
- able to perform pressure relief maneuvers independently
Exclusion Criteria:
- unable/unwilling to return to clinic for follow-up visits
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：防止
- 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：An interactive telehealth monitoring and biofeedback system
Participants in this group will receive feedback of pressure relief maneuvers and wheelchair propulsion activity.
Feedback for pressure relief will include information during the activity to identify adequate duration and magnitude of pressure relief activity, reminders of when the next pressure relief is due, and daily aggregate information regarding the number of successful pressure relief maneuvers performed.
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A pressure sensitive mat located under the user's wheelchair seat cushion and a wheelchair propulsion monitoring device attached to the chair which are interfaced with a phone App based user interface to provide feed back to promote physical activity and pressure relief maneuver performance among wheelchair users.
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偽コンパレータ：Education Control
Participants will receive education on the importance and recommended frequency of pressure relief maneuver for prevention of pressure ulcer/injury and on the importance and recommended amounts of physical activity for health.
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Participants will receive education on importance of pressure relief maneuvers and physical activity and the recommended amounts of each for prevention of pressure ulcer/injury and for physical health.
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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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Recurrence of Pressure Ulcer
時間枠：Any time during the one year active phase of the study intervention
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Any stage of Pressure Ulcer/Injury identified in the ischial region
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Any time during the one year active phase of the study intervention
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Change in mean number of cycles of self-propulsion per day from Baseline
時間枠：The four weeks preceding the 12 month assessments
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The increase or decrease in number of cycles of self-propulsion per day over the 4 weeks preceding the 12 month assessment
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The four weeks preceding the 12 month assessments
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Change in mean number of pressure relief maneuvers per day from Baseline
時間枠：The four weeks preceding the 12 month assessments
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The increase or decrease in mean number of pressure relief maneuvers per day over the 4 weeks preceding the 12 month assessment from Baseline
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The four weeks preceding the 12 month assessments
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Time to Recurrence of Pressure Ulcer
時間枠：Any time during the one year active phase of the study intervention
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The number of days from study entry to identification of recurrence of Pressure Ulcer/Injury
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Any time during the one year active phase of the study intervention
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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 in Patient Health Questionnaire-9 score
時間枠：12 months
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Change in Questionnaire scores measuring depressive symptoms at 12 month assessment from baseline score
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12 months
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Change in University of Washington Self Efficacy Short Form
時間枠：12 months
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Change in scores on Questionnaire measuring self-efficacy at 12 month assessment from baseline score
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12 months
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Change in Reintegration to Normal Living Index
時間枠：12 months
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Change score on Questionnaire measuring participation at 12 month assessment from baseline score
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12 months
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Change in Satisfaction with Life Scale
時間枠：12 months
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Change in score on Questionnaire measuring satisfaction with life at 12 month assessment from baseline score
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12 months
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協力者と研究者
捜査官
- 主任研究者：Sara Mulroy, PhD, PT、Rancho Los Amigos National Rehab Ce
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (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 (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
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