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Sensor Ankle Brace for Special Operations Rehabilitation

2026年8月21日 更新者:Allison Gruber, PhD、Indiana University

Sensor Ankle Brace for Special Operations Rehabilitation - Phase 2

The primary purpose of this study overall is to validate a modified version of a commercially available ankle brace. Inertial measurement unit sensors will be incorporated into an existing ankle brace ("sXAB") by TayCo Brace, Inc. In two consecutive studies, gait metrics data collected from the sensor enabled ankle brace will be compared to data collected by the gold-standard equipment that is used in research and clinical settings to determine whether the sXAB performs adequately in terms of measurement or technical feasibility prior to further clinical evaluation. In the Phase 2 protocol, the sXAB will be validated on healthy subjects wearing combat boots performing walking, running, jumping, and stair climbing activities. These movements were selected because they simulate key movements performed during operational activities. All participants experience both conditions: with an ankle brace and without an ankle brace. Comparisons are made within-subject between brace and no-brace conditions. It is hypothesized that the sensor-enabled ankle brace will measure gait metrics with a high degree of accuracy (within 5%) when compared against the gold-standard lab equipment (i.e., motion capture and research-grade inertial measurement units).

調査の概要

詳細な説明

All human subjects activities are taking place at the Indiana University Bloomington (IUB) campus. Potential participants for the Phase 2 study protocol will be recruited from the community and the IUB campus. Potential participants will either contact the research team to complete the initial screening or respond to the flyer via a QR code that takes them directly to the online version of the screening form. The screening form asks yes/no questions from the Physical Activity Readiness Questionnaire (PARQ+) and additional questions about the individuals health history, musculoskeletal injury history, and current physical activity levels. After initial screening to determine eligibility, provisionally eligible participants will come to the laboratory on the IUB campus to complete enrollment and study procedures.

At the first in-person visit, participants will read the informed consent document and, after all questions have been answered, sign the informed consent document if they agree to participate in the study. Next, participants will complete a health history questionnaire which repeats the PARQ+ questions and additional health history questions presented in the initial screening to confirm eligibility. Foot length measurements and additional surveys (i.e., the Identification of Functional Ankle Instability (IDFAI) and International Physical Activity Questionnaire - Short Form (IPAQ)) will be administered. If eligibility is confirmed, participants will be enrolled and complete the study procedures. After eligibility is confirmed, participants will also complete the past-year physical activity questionnaire (PYPAQ) and a running history questionnaire.

Following the surveys, height and weight will be measured then the dominant limb test and the preferred speed test will be performed. The dominant limb test determines whether the right or left lower limb is the dominant limb by observing which limb participants use to kick a ball. The preferred speed test involves the participant walking or running at or near their reported preferred speed (or 2.9 mph for walking and 4.5 mph for running if preferred speed is unknown). The speed will be blinded to the participant. The researcher will increase or decrease the speed in 0.5-1.0 mph increments until the participant identifies the same speed as their preferred speed three times.

Next, the participant will be prepared for data collection. Participants will be asked to change into form fitting clothing (provided by the laboratory, if needed) and combat boots provided by the laboratory (Phase 2). Reflective markers and the lab's research-grade inertial measurement units (IMUs) will be placed on anatomical landmarks of both feet, lower-legs, thighs, and pelvis, and the sensor-enabled ankle brace ("sXAB") will be secured on the dominant limb, if the first randomized condition is the brace condition. Participants will warm-up by walking on a treadmill before completing each of the brace conditions (brace and no-brace) to acclimate wearing the brace and/or the reflective markers and lab IMUs. Participants will then be asked to complete the movement tests specific to each protocol (Phase 2: standing balance, stairs, drop landing, walking at preferred speed, and running at preferred speed) while wearing the sXAB and without wearing the brace ("no brace" condition) as three-dimensional motion capture data, force plate data, IMU data, and data from the sXAB (if worn) are recorded. The order of the bracing conditions will be presented in a random order. The brace will be worn on the dominant limb. Within each brace condition, the standing balance test will be performed first then the remaining movements will be presented in a random order. After the first brace condition is complete, the participant will be prepared to complete the second brace condition then repeat the warm-up, standing balance test, and the movement tests.

Participants may complete Phase 2 activities in either one or two study visits, depending on participant preference.

研究の種類

介入

入学 (推定)

40

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。

研究連絡先

  • 名前:Allison H Gruber, PhD
  • 電話番号:8128562447
  • メール:ahgruber@iu.edu

研究連絡先のバックアップ

  • 名前:Adriana M Alamilla, MS
  • 電話番号:708-745-8368
  • メール:admiltko@iu.edu

研究場所

    • Indiana
      • Bloomington、Indiana、アメリカ、47405
        • 募集
        • Indiana University, School of Public Health - Bloomington
        • コンタクト:
          • Allison H Gruber, PhD
          • 電話番号:8128562447
          • メール:ahgruber@iu.edu
        • コンタクト:
          • Adriana M Alamilla, MS
          • 電話番号:Gruber 708-745-8368
          • メール:admiltko@iu.edu
        • 主任研究者:
          • Allison H Gruber, PhD

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

  • 大人

健康ボランティアの受け入れ

はい

説明

Inclusion Criteria:

  • Healthy adults: ages 18 - 40 years
  • considered "healthy to exercise" as determined by the physical activity readiness questionnaire (PAR-Q)
  • Classified as "moderate" or "high" activity level as defined by the scoring criteria of the International Physical Activity Questionnaire - Short Form (IPAQ)
  • Comfortably fit into combat boots provided by the laboratory (Men's sizes 8, 9, 10, 11, 12 and Women's sizes 6, 7, 8, 9, 10 will be purchased, and so participants with foot lengths of 22.54-29.27.8 cm are expected to fit in the boots provided).

Exclusion Criteria:

  • Smoking tobacco on a regular basis
  • Previous lower back or lower limb surgery (including the joints of the pelvis and lower limbs)
  • Musculoskeletal injury sustained within the 12-weeks prior to enrollment . A musculoskeletal injury is defined as musculoskeletal pain causing a reduction or stoppage of normal physical activity for at least 3 days within a 7-day period, and have not returned to their normal physical activity and exercise without pain for at least the last 6-weeks.
  • Pregnant (women only)
  • Current or history of an unresolved musculoskeletal, neurological, cardiovascular, pulmonary/respiratory, metabolic, renal condition, disease, or problem.
  • Torn anterior or posterior cruciate ligament (ACL or PCL).
  • Any other disease or problems that may affect movement or the ability to exercise even at a low intensity.
  • Identification of Functional Ankle Instability (IDFAI) score of <11.
  • unable to comfortably perform the drop landing condition.
  • Feet are too large or too small to fit comfortably in the combat boots provided.

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: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
実験的:シングルグループ:ブレースおよびブレースなしの条件
この研究には、2つの被験者内条件下で動きのタスクを完了する参加者の単一グループ(2つのコホートにわたって収集)が含まれます。(1)センサー対応の足首ブレース(「ブレース」条件)を着用し、(2)ブレースなし(「ブレースなし」状態)。 各参加者は独自のコントロールとして機能します。 ブレース条件の順序は無作為化され、すべての参加者は両方の条件を経験します。
介入は、Tayco Brace、Inc。のセンサー対応バージョンです。アスレチックXアンクルブレース(SXAB)は、市販の慣性測定ユニット(IMU)をブレースの構造に統合します。 ブレースは、機能運動タスク中に支配的な肢の足首に着用し、実験用グレードの測定システムと比較して有効な歩行とバランスメトリックを生成する能力を評価します。

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
Validation of kinematic data collected by the sensor-enabled ankle brace (sXAB)
時間枠:At study visit(s), completed up to 1 week after enrollment.
This outcome evaluates whether kinematic data collected using the sensor-enabled ankle brace (sXAB) are sufficiently accurate and reliable compared to gold-standard laboratory systems (motion capture and force plates). Agreement between sXAB and laboratory reference systems will be assessed using measures of validity and reliability for ankle kinematic variables, including sagittal plane joint angles and range of motion. Data are collected during brace conditions across multiple movement tasks.
At study visit(s), completed up to 1 week after enrollment.
Validation of spatiotemporal parameters collected by the sensor-enabled ankle brace (sXAB)
時間枠:At study visit(s), completed up to 1 week after enrollment.
This outcome evaluates whether spatiotemporal parameters collected using the sensor-enabled ankle brace (sXAB) are sufficiently accurate and reliable compared to gold-standard laboratory systems (motion capture and force plates). Agreement between sXAB and laboratory reference systems will be assessed using measures of validity and reliability for stance time, stride length, gait speed. Data are collected during brace conditions across multiple movement tasks.
At study visit(s), completed up to 1 week after enrollment.

二次結果の測定

結果測定
メジャーの説明
時間枠
Activity Recognition
時間枠:At study visit(s), completed up to 1 week after enrollment
The inertial measurement unit (IMU) data collected from the sensor-enabled ankle brace (sXAB) will be analyzed to determine what activity was occurring at which times during the data set.
At study visit(s), completed up to 1 week after enrollment
Validation of kinetic data collected by the sensor-enabled ankle brace (sXAB)
時間枠:At study visit(s), completed up to 1 week after enrollment
This outcome evaluates whether kinetic data collected using the sensor-enabled ankle brace (sXAB) are sufficiently accurate and reliable compared to gold-standard laboratory systems (motion capture and force plates). Agreement between sXAB and laboratory reference systems will be assessed using measures of validity and reliability for peak vertical ground reaction force and total vertical impulse. Data are collected during brace conditions across multiple movement tasks.
At study visit(s), completed up to 1 week after enrollment
Validation of balance data collected by the sensor-enabled ankle brace (sXAB)
時間枠:At study visit(s), completed up to 1 week after enrollment
This outcome evaluates whether balance data collected using the sensor-enabled ankle brace (sXAB) are sufficiently accurate and reliable compared to gold-standard laboratory systems (motion capture and force plates). Agreement between sXAB and laboratory reference systems will be assessed using measures of validity and reliability for postural sway amplitude and velocity. Data are collected during brace conditions across multiple movement tasks.
At study visit(s), completed up to 1 week after enrollment
Equivalence of kinematic data collected by the sensor-enabled ankle brace (sXAB)
時間枠:At study visit(s), completed up to 1 week after enrollment
This outcome evaluates whether kinematic data collected using the sensor-enabled ankle brace (sXAB) are equivalent to data collected using laboratory systems (research-grade IMUs). Agreement between sXAB and laboratory reference systems will be assessed using measures of validity and reliability for sagittal plane joint angles, range of motion. Data are collected during brace conditions across multiple movement tasks.
At study visit(s), completed up to 1 week after enrollment
Equivalence of spatiotemporal parameters collected by the sensor-enabled ankle brace (sXAB)
時間枠:At study visit(s), completed up to 1 week after enrollment
This outcome evaluates whether spatiotemporal parameters collected using the sensor-enabled ankle brace (sXAB) are equivalent to data collected using gold-standard laboratory systems (research-grade IMUs). Agreement between sXAB and laboratory reference systems will be assessed using measures of validity and reliability for stance time, stride length, gait speed. Data are collected during brace conditions across multiple movement tasks.
At study visit(s), completed up to 1 week after enrollment

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:Allison H Gruber, PhD、Indiana University

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。

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)

2026年5月5日

一次修了 (推定)

2026年9月1日

研究の完了 (推定)

2026年9月1日

試験登録日

最初に提出

2026年8月17日

QC基準を満たした最初の提出物

2026年8月17日

最初の投稿 (実際)

2026年8月20日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月25日

QC基準を満たした最後の更新が送信されました

2026年8月21日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

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

はい

米国で製造され、米国から輸出された製品。

いいえ

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