Assistive ExoSkeletons to Enable Wearable Rehabilitation Robotics
Assistive ExoSkeleton & ExoTendon Platform to Enable Wearable Rehabilitation Robotics
調査の概要
詳細な説明
Study will evaluate the use of lower-limb assistive exo-skeletons worn on the ankle and foot. Participants will include those with self-described history of Diabetic Foot Ulcer and age-matched healthy volunteers. Participants will wear the exo-skeletons and will be asked to walk 32 feet, and to stand quietly for 30 seconds.
Measurements will be taken to evaluate how the exoskeletons affect how people walk, and will also evaluate the pressure on the bottom of their feet. These measurements will be repeated multiple times to evaluate four different exo-tendon spring rates, and two sets of control shoes.
Exo-skeletons have been shown to reduce the pressure on the bottoms of people's feet and to reduce the effort to walk. This study is necessary to understand the contribution of different levels of exo-skeleton spring force to these effects.
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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California
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Los Angeles、California、アメリカ、90242
- Rancho Los Amigos
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Connecticut
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New Haven、Connecticut、アメリカ、06515
- Southern CT State University
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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:
- Self-reported history of diabetic foot ulcer
Exclusion Criteria:
- Unable to continuously ambulate/walk ≥ 40 feet without an assistive device, such as a cane or walker
- Signs/symptoms of an infected foot lesion/ulcer as determined by a basic foot exam
- Trans-metatarsal foot amputation or more significant amputation.
- Symptomatic for signs/symptoms of cardiovascular disease as determined from interpretation of the 2017 PAR-Q+ (predicated on participant responses of "yes" indicating symptomatic/unstable medical conditions to page 2 and page 3 of the 2017 PAR-Q)
- Participants will be excluded from this study if they demonstrate pre-participation, or chronic, signs/symptoms of hypoglycemia: Confusion, unusual headache, unusual visual disturbances, self-reported mental dullness, shakiness, self-reported weakness, abnormal sweating, undue nervousness/anxiety, and/or tingling of the mouth, toes, and/or fingers or if they answer yes to question 5b and 5c of the 2017 PAR-Q+ .
- Participants will be temporarily excluded from this study if they are symptomatic for acute illness such as cold or fever. If the participant is symptomatic for acute illness such as cold or fever, participation will be reconsidered upon illness resolution.
- If participants answer yes to question 4a of the 2017 PAR-Q+ and if they demonstrate pre-study participation resting blood pressure < 90/60 mmHg and >140/90 mmHg .
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：他の
- 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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実験的：Primary Arm
Participants will be used as their own controls.
Participants will be evaluated using exo-skeletons with non-motorized spring elements in parallel to the Achilles tendon.
Up to 5 different levels of spring force will be evaluated to evaluate the impact upon plantar pressure and measures of fall risk.
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Ankle-foot exoskeleton - device to help reduce load on the bottom of the front of the foot
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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 |
|---|---|---|
|
Forefoot plantar pressure
時間枠：30 minutes
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Measurements of the force and pressure on the bottom of the front of the foot
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30 minutes
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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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Measures of fall risk
時間枠：30 minutes
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Measurements of postural sway, balance and gait speed to provide an indication of participant's risk of falling while wearing different shoes.
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30 minutes
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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
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。