From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices

Overview

About this study

This study is designed to support evidence-based practice and optimal care by evaluating how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influences outcomes following traumatic lower extremity injury.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kenton Kaufman, Ph.D.

Open for enrollment

Contact information:

Christine Deml CCRP

(507) 266-0984

Deml.Christine@mayo.edu

More information

Publications

Publications are currently not available