Sensor Ankle Brace for Gait and Balance Disorders

Overseen By Adriana M Alamilla, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Smoking, Surgery, Musculoskeletal, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new ankle brace equipped with sensors to determine if it accurately tracks movements such as walking and running. The goal is to compare the brace's measurements to top-tier lab equipment to ensure reliability for future use. Participants will try the brace in a lab setting with various footwear, including sneakers and combat boots. Ideal candidates for this trial are healthy, regularly active individuals who can fit into the provided combat boots. As an unphased trial, this study allows participants to contribute to the development of innovative technology that could enhance movement tracking for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves healthy adults without significant medical conditions, it's likely that participants are not on regular medications.

What prior data suggests that this device is safe for use in gait and balance assessments?

Research has shown that the sensor-enabled ankle brace, known as sXAB, is generally easy to use. No major side effects have been reported from wearing this brace. Designed to assist with walking and balance issues, it uses sensors to track movements, enhancing safety by identifying potential risks. While detailed information on side effects is lacking, the emphasis on safety and movement tracking suggests it is a low-risk option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional ankle braces that focus solely on structural support, the Sensor-enabled Athletic X Ankle Brace (sXAB) is unique because it integrates advanced sensor technology to actively monitor gait and balance. This allows for real-time feedback and personalized adjustments, which could enhance recovery and performance. Researchers are excited about the potential for sXAB to not just support the ankle but to also provide data-driven insights into movement patterns, offering a more holistic approach to managing gait and balance disorders.

What evidence suggests that this sensor-enabled ankle brace is effective for gait and balance disorders?

Research has shown that the ankle brace with sensors can accurately track movements like walking, running, and climbing stairs. Studies indicate that these sensors provide precise information on posture, balance, and walking speed, aiding in the evaluation of overall mobility. In this trial, participants will wear the sensor-enabled ankle brace and also experience periods without it, allowing for a comparison of movement patterns. Tests with similar devices have detected changes in walking patterns, such as those caused by foot drop, a condition where the front of the foot drops due to weakness. The sensors in this brace aim to match the accuracy of advanced lab equipment, with only a 5% difference. This suggests the brace could be a valuable tool for monitoring and improving movement and balance. ^{1 2 3 4 6}

Who Is on the Research Team?

Allison H Gruber, PhD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for healthy individuals who can perform specific movements like walking, running, jumping, and stair climbing. Participants must be able to complete tasks both with and without an ankle brace. There's no mention of exclusion criteria provided.

Inclusion Criteria

For cohort 2 only:

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

For cohort 2 only:

Identification of Functional Ankle Instability (IDFAI) score of <11

Feet are too large or too small to fit comfortably in the combat boots provided.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Protocol 1

Participants complete movement tests with and without the sensor-enabled ankle brace in standard tennis shoes/sneakers

1 week

1 visit (in-person)

Protocol 2

Participants complete movement tests with and without the sensor-enabled ankle brace in combat boots

1 week

1 visit (in-person)

Follow-up

Participants are monitored for data accuracy and reliability after completing protocols

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Sensor-enabled Athletic X Ankle Brace (sXAB)

Trial Overview The study tests a sensor-enabled athletic ankle brace (sXAB) against gold-standard gait analysis equipment. It aims to validate the accuracy of sXAB sensors in measuring gait metrics during lab simulations of operational activities.

How Is the Trial Designed?

Group I: Single Group: Brace and No-Brace Conditions Experimental Treatment 1 Intervention

This study includes a single group of participants (collected across two cohorts) who complete movement tasks under two within-subject conditions: (1) wearing a sensor-enabled ankle brace ("brace" condition), and (2) without the brace ("no-brace" condition). Each participant serves as their own control. The brace condition order is randomized, and all participants experience both conditions.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

United States Air Force

Collaborator

Trials

21

Recruited

52,700+

TAYCO BRACE, INC

Collaborator

Citations

1. withpower.com withpower.com/trial/phase-gait-7-2025-6285b

Sensor Ankle Brace for Gait and Balance Disorders 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- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11593354/

Deep Learning and IoT-Based Ankle–Foot Orthosis for ... IMU sensors provide accurate data on linear and angular acceleration, enabling a comprehensive assessment of posture, balance, and gait speed.

3. preprints.org preprints.org/manuscript/202307.1118

Intelligent IoT-enabled Ankle Brace: Enhancing Mobility ... These sensors provide valuable data that is utilized to evaluate the patient's overall well-being and response to therapy. In the event of a ...

4. mdpi.com mdpi.com/2076-0825/14/11/531

Design of a Smart Foot–Ankle Brace for Tele-Rehabilitation ... Experiments using a 3D-printed insole demonstrated that the device detects foot-drop-related gait deviations, with toe acceleration approximately twice that of ...

5. medrxiv.org medrxiv.org/content/10.1101/2025.05.02.25326892v1.full-text

Assessing Ankle Range of Motion with Wearable Technology This study evaluates the novel Ambulosono device, a sensor-based tool, against the traditional goniometer for assessing Ankle ROM in healthy participants.

6. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT07085416?keyword=%22Wearable%20Electronic%20Devices%22

Sensor Ankle Brace for Special Operations Rehabilitation The study aims to determine whether gait and balance measures obtained from an ankle brace integrated with inertial measurement units are comparable to ...