RECRUITING

Sensor Ankle Brace for Special Operations Rehabilitation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary purpose of this study is to conduct a clinical trial to test a prototype device for feasibility and not health outcomes. To do this, the investigators will evaluate the performance of commercially available inertial measurement unit sensors incorporated into an existing ankle brace ("sXAB") by TayCo Brace, Inc. We will compare the gait metrics calculated from the sensors incorporated into the brace with 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. The sensors in the ankle brace will be validated in the lab, first on healthy subjects walking in standard tennis shoes/sneakers (protocol 1), and secondarily in the lab on healthy subjects wearing combat boots performing walking, running, jumping, and stair climbing (protocol 2). These movements were selected because they simulate key movements performed during operational activities. Protocol 1 will take place first, then aspects of the sXAB will be evaluated and implemented, then protocol 2 will take place. Participants completing protocol 1 are eligible to complete protocol 2. The study includes two cohorts of participants completing different functional tasks. 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).

Official Title

Sensor Ankle Brace for Special Operations Rehabilitation

Quick Facts

Study Start:2025-10-16
Study Completion:2026-06-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07085416

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Allison H Gruber, PhD
CONTACT
8128562447
ahgruber@iu.edu
Adriana M Alamilla, MS
CONTACT
708-745-8368
admiltko@iu.edu

Principal Investigator

Allison H Gruber, PhD
PRINCIPAL_INVESTIGATOR
Indiana University

Study Locations (Sites)

Indiana University, School of Public Health - Bloomington
Bloomington, Indiana, 47405
United States

Collaborators and Investigators

Sponsor: Indiana University

  • Allison H Gruber, PhD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-10-16
Study Completion Date2026-06-18

Study Record Updates

Study Start Date2025-10-16
Study Completion Date2026-06-18

Terms related to this study

Keywords Provided by Researchers

  • adult
  • gait
  • gait analysis
  • humans
  • ankle brace
  • motion capture
  • sensor validation
  • wearable electronic devices
  • wearable sensors
  • inertial measurement unit
  • IMU
  • locomotion
  • running
  • walking
  • landing
  • stair ascent
  • stair descent

Additional Relevant MeSH Terms

  • Gait
  • Balance
  • Biomechanical Data
  • Postural Control
  • Locomotion