Study Summary
This trial will examine if carbon fiber braces can reduce forces on ankle cartilage to stop arthritis from developing after a fracture. The brace geometry will be varied to find the most effective design.
Eligible Conditions
- Osteoarthritis of the Ankle
- Posttraumatic Osteoarthritis
- Ankle Fracture
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 13 Secondary · Reporting Duration: Baseline
After completing other study activities
Participant Device Preference
Baseline
Ankle Range of Motion
Center of pressure velocity magnitude
Center of pressure velocity timing
Four Square Step Test (4SST)
Joint Contact Stress Exposure (Model estimated)
Medial Gastrocnemius Muscle Activity (Electromyography)
Modified Socket Comfort Score (Comfort and Smoothness)
Numerical Pain Rating Scale
Peak Ankle Moment
Peak Ankle Power
Plantar Force
Rectus Femoris Muscle Activity (Electromyography)
Semi-Structured Interview
Sit to Stand 5 Times (STS5)
Soleus Muscle Activity (Electromyography)
The Orthotics Prosthetics Users' Survey (OPUS)
Tibialis Anterior Muscle Activity (Electromyography)
Vastus Medialis Muscle Activity (Electromyography)
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
No Device
1 of 4
CDO-A
1 of 4
CDO-B
1 of 4
CDO-C
1 of 4
Active Control
Experimental Treatment
30 Total Participants · 4 Treatment Groups
Primary Treatment: Custom Carbon Fiber Dynamic Orthosis (CDO) · No Placebo Group · N/A
CDO-A
Device
Experimental Group · 1 Intervention: Custom Carbon Fiber Dynamic Orthosis (CDO) · Intervention Types: DeviceCDO-B
Device
Experimental Group · 1 Intervention: Custom Carbon Fiber Dynamic Orthosis (CDO) · Intervention Types: DeviceCDO-C
Device
Experimental Group · 1 Intervention: Custom Carbon Fiber Dynamic Orthosis (CDO) · Intervention Types: DeviceNo DeviceNoIntervention Group · 1 Intervention: No Device · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline
Who is running the clinical trial?
University of IowaLead Sponsor
420 Previous Clinical Trials
878,893 Total Patients Enrolled
13 Trials studying Osteoarthritis
4,814 Patients Enrolled for Osteoarthritis
University of DelawareOTHER
136 Previous Clinical Trials
36,756 Total Patients Enrolled
5 Trials studying Osteoarthritis
394 Patients Enrolled for Osteoarthritis
Bio-Mechanical CompositesUNKNOWN
1 Previous Clinical Trials
34 Total Patients Enrolled
Jason M Wilken, PT, PhDPrincipal InvestigatorUniversity of Iowa
10 Previous Clinical Trials
306 Total Patients Enrolled
1 Trials studying Osteoarthritis
20 Patients Enrolled for Osteoarthritis
Eligibility Criteria
Age 18 - 65 · All Participants · 23 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have injuries or wounds on your foot or calf that make it impossible to use the CDO.
Your shoe size falls between women's 8 and 13.5 or men's 6.5 and 12.
You can move your legs and back normally.
You can jump without experiencing any pain.
You should be able to crouch down completely without experiencing any pain.
You have a moderate or severe brain injury.
You recently had surgery or an injury on your lower extremity that limits movement for more than 6 weeks.
You have severe obesity with a body mass index (BMI) greater than 40.
You have had a serious broken bone in your ankle within the last 5 years.
If you had a broken bone, it must be completely healed before you can participate.
You are able to walk slowly or moderately.
Your shoe size should be between women's 8 and 13.5 or men's 6.5 and 12.
You need help from a device to move around.