N/A N=50 Randomized Treatment

Ankle Foot Orthosis Comparative Effect

Foot Injuries and Disorders

Bottom Line

View on ClinicalTrials.gov: NCT03901053 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2025

Primary outcome: Primary: PROMIS Patient Reported Outcomes for Physical Function — 44.78; 45.02 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Reaktiv AFO (Device); PhatBrace AFO (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Jason Wilken
Primary completion: Dec 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY PROMIS Patient Reported Outcomes for Physical Function	44.78; 45.02	—
PRIMARY PROMIS Patient Reported Outcomes for Pain Interference	55.22; 53.49	—
PRIMARY Activities-Specific Balance Confidence (ABC)	76.37; 76.92	—
PRIMARY Satisfaction With Device (OPUS - CSD)	35.88; 36.04	—
PRIMARY Modified Socket Comfort Score (Comfort)	7.12; 7.12	—
PRIMARY Modified Socket Comfort Score (Comfort and Smoothness)	7.65; 7.46	—
PRIMARY Numerical Pain Rating Scale	1.85; 1.68	—
PRIMARY Participant Device Preference	10; 16	—
PRIMARY Four-square Step Test (4SST- Timed)	7.39; 7.06	—
PRIMARY Self-selected Walking Velocity (SSWV - Timed)	4.46; 4.49	—
PRIMARY 10 Meter Shuttle Run (10M Shuttle - Timed)	19.05; 19.05	—
PRIMARY Ankle Joint Power	1.43; 1.29	—
PRIMARY Center of Pressure Velocity Timing	25.81; 15.11	—
PRIMARY Center of Pressure Velocity Magnitude	0.89; 0.75	—
SECONDARY PROMIS Patient Reported Outcomes for Satisfaction With Participation in Social Activities	49.39; 48.42	—
SECONDARY Paffenbarger Physical Activity Questionnaire	2.17; 1.66; 1.75; 2.39	—
SECONDARY Ankle Joint Moment	1.43; 1.29	—

Summary

The proposed effort is designed to support evidence-based practice and optimal care by evaluating how the form, fit and function of two commercially available carbon fiber custom fit braces (Orthoses) influences outcomes following extremity injury. Early data suggests that custom fit carbon fiber braces can significantly improve function following severe lower leg injuries. The proposed study will provide evidence that can be used by clinicians to guide their practice, including care for service members, veterans and civilians who have experienced a high-energy traumatic injury to their lower leg.

Eligibility Criteria

Inclusion Criteria

Ages: 18-65
Sustained a function limiting, below the knee, traumatic lower leg injury that occurred greater than two years ago
Weakness of ankle plantarflexors ( 4/10 on verbal numeric pain rating scale), ankle or hindfoot fusion or candidate for ankle or hindfoot fusion, AND/OR a candidate for amputation secondary to ankle/foot impairment
Ability to walk 50 feet without using a cane or crutch
Ability to walk at a slow to moderate pace
Able to read and write in English and provide written informed consent

Exclusion Criteria

Pain > 8/10 while walking
Ankle weakness as a result of spinal cord injury or central nervous system pathology
Require a knee stabilizing device (i.e. Knee-Ankle Foot Orthosis or Knee Orthosis) to perform daily activities
Surgery on study limb anticipated in the next 6 months
Medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, heart condition, clotting disorder, lung condition, stroke, vestibular disorder)
Nerve, muscle, bone, or other condition limiting function of the contralateral extremity
BMI greater than 45
Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing
Pregnancy- Per participant self-report. Due the expected small number of pregnant individuals and resulting inability to account for its effect on resulting outcomes participants will be withdrawn from the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03901053). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.