Clinical Trials

Inclusion Criteria:

* Between the ages of 18 and 65
* 2 or more years from a traumatic injury below the knee
* Ability to be fit with an orthosis
* Any of the following:

* Weakness of ankle plantarflexors (\<4/5 on manual muscle test)
* Limited pain-free ankle motion (dorsiflexion (DF) \<10° or plantarflexion (PF) \<20°)
* Mechanical pain with loading to hindfoot/midfoot (\>4/10 Numerical pain rating scale)
* Fusion or candidate for fusion of the ankle or hindfoot
* Candidate for amputation secondary to ankle/foot injury and impairment

Exclusion Criteria:

* Pain greater than 8/10 at rest
* Ankle weakness or spasticity as a result of spinal cord injury or central nervous system pathology
* Use of an orthosis including the knee
* Non-ambulatory
* Surgery on study limb anticipated in next 4 months
* Medical or psychological conditions that would influence functional testing (e.g., severe traumatic brain injury, stroke, heart disease, vestibular disorder)
* Neurologic, musculoskeletal, or other conditions limiting function of the contralateral extremity
* Uncorrected visual or hearing impairments
* Pregnancy
* Non-English speaking
* BMI \> 40

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/12/2024. Questions regarding updates should be directed to the study team contact.