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New treatment option for Gait
Official title Sensor Ankle Brace for Special Operations Rehabilitation
ClinicalTrials.gov ID: NCT07085416
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40. Healthy volunteers may be eligible.
You may be able to join if
- for both cohorts:
- Healthy adults: ages 18 - 40 years
- considered "healthy to exercise" as determined by the physical activity readiness questionnaire (PAR-Q) Additional specific to cohort 2 only:
- Classified as "moderate" or "high" activity level as defined by the scoring criteria of the International Physical Activity Questionnaire - Short...
- 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...
You likely can't join if
- for both cohorts:
- 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...
- Pregnant (women only)
- Current or history of an unresolved musculoskeletal, neurological, cardiovascular, pulmonary/respiratory, metabolic, renal condition, disease, or...
See the full eligibility criteria
- for both cohorts:
- Healthy adults: ages 18 - 40 years
- considered "healthy to exercise" as determined by the physical activity readiness questionnaire (PAR-Q) Additional specific to 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...
- for both cohorts:
- 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...
- 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. Additional Exclusion Criteria specific to cohort 2 only:
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bloomington, Indiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bloomington, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.