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Sensor Ankle Brace for Special Operations Rehabilitation

21. august 2026 oppdatert av: 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).

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Allison H Gruber, PhD
  • Telefonnummer: 8128562447
  • E-post: ahgruber@iu.edu

Studer Kontakt Backup

  • Navn: Adriana M Alamilla, MS
  • Telefonnummer: 708-745-8368
  • E-post: admiltko@iu.edu

Studiesteder

    • Indiana
      • Bloomington, Indiana, Forente stater, 47405
        • Rekruttering
        • Indiana University, School of Public Health - Bloomington
        • Ta kontakt med:
        • Ta kontakt med:
          • Adriana M Alamilla, MS
          • Telefonnummer: Gruber 708-745-8368
          • E-post: admiltko@iu.edu
        • Hovedetterforsker:
          • Allison H Gruber, PhD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Enkelt gruppe: stag og ikke-størrelsesforhold
Denne studien inkluderer en enkelt gruppe deltakere (samlet på tvers av to årskull) som fullfører bevegelsesoppgaver under to forhold innen faget: (1) iført en sensoraktivert ankelstag ("stag" -tilstand), og (2) uten stag ("no-Brace" -tilstand). Hver deltaker fungerer som sin egen kontroll. Stag -tilstandsordren er randomisert, og alle deltakerne opplever begge forholdene.
Intervensjonen er en sensoraktivert versjon av Tayco Brace, Inc. Athletic X Ankel Brace (SXAB), som integrerer kommersielt tilgjengelige treghetsmålingsenheter (IMU-er) i strukturen til staget. Staget bæres på ankelen til den dominerende lemmen under funksjonelle bevegelsesoppgaver for å evaluere dens evne til å produsere gyldige gang- og balansemålinger sammenlignet med målesystemer for laboratorieklasse.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Validation of kinematic data collected by the sensor-enabled ankle brace (sXAB)
Tidsramme: 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)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Activity Recognition
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Allison H Gruber, PhD, Indiana University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. mai 2026

Primær fullføring (Antatt)

1. september 2026

Studiet fullført (Antatt)

1. september 2026

Datoer for studieregistrering

Først innsendt

17. august 2026

Først innsendt som oppfylte QC-kriteriene

17. august 2026

Først lagt ut (Faktiske)

20. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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