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Sensor Ankle Brace for Special Operations Rehabilitation

2026년 8월 21일 업데이트: 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).

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

40

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Allison H Gruber, PhD
  • 전화번호: 8128562447
  • 이메일: ahgruber@iu.edu

연구 연락처 백업

  • 이름: Adriana M Alamilla, MS
  • 전화번호: 708-745-8368
  • 이메일: admiltko@iu.edu

연구 장소

    • Indiana
      • Bloomington, Indiana, 미국, 47405
        • 모병
        • Indiana University, School of Public Health - Bloomington
        • 연락하다:
          • Allison H Gruber, PhD
          • 전화번호: 8128562447
          • 이메일: ahgruber@iu.edu
        • 연락하다:
          • Adriana M Alamilla, MS
          • 전화번호: Gruber 708-745-8368
          • 이메일: admiltko@iu.edu
        • 수석 연구원:
          • Allison H Gruber, PhD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

예

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 단일 그룹 : 브레이스 및 비경사 조건
이 연구에는 두 개의 주제 내 조건 하에서 움직임 작업을 완료하는 단일 참가자 그룹 (2 개의 코호트에 걸쳐 수집)이 포함되어 있습니다. 각 참가자는 자신의 통제 역할을합니다. 브레이스 조건 순서는 무작위로 표시되며 모든 참가자는 두 조건을 모두 경험합니다.
중재는 Tayco Brace, Inc. Athletic X Ankle Brace (SXAB)의 센서 지원 버전으로, 상업적으로 이용 가능한 관성 측정 유닛 (IMUS)을 브레이스 구조에 통합합니다. 브레이스는 기능적 움직임 작업 중에 지배적 인 사지의 발목에 착용하여 실험실 등급 측정 시스템과 비교하여 유효한 보행 및 균형 메트릭을 생성하는 능력을 평가합니다.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Validation of kinematic data collected by the sensor-enabled ankle brace (sXAB)
기간: 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)
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Activity Recognition
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Allison H Gruber, PhD, Indiana University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 5일

기본 완료 (추정된)

2026년 9월 1일

연구 완료 (추정된)

2026년 9월 1일

연구 등록 날짜

최초 제출

2026년 8월 17일

QC 기준을 충족하는 최초 제출

2026년 8월 17일

처음 게시됨 (실제)

2026년 8월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 21일

마지막으로 확인됨

2026년 8월 1일

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아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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