Clinical trial NCT05456295: Comparative Effect of Carbon Fiber Orthosis Cuff Design on Preference, Comfort, and Mechanics
Official title: Comparative Effect of Carbon Fiber Orthosis Cuff Design on Preference, Comfort, and Mechanics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Lower Limb Injury
Post-Traumatic Osteoarthritis
Keywords: Gait Analysis
Ankle Foot Orthosis
Carbon Fiber
Biomechanics
Adult
Arthritis
Healthy
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Fabtech Systems
First posted: 2022-07-13
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants will be cast and fit with CDOs with four different proximal cuff designs. CDOs will be labeled as CUFF-A, CUFF-B, CUFF-C, CUFF-D. Testing order of the proximal cuff designs will be randomized to prevent influence of study results.
Primary purpose: OTHER

Brief summary: Carbon fiber custom dynamic orthoses (CDOs) consist of a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that stores and returns energy during gait, and a carbon fiber foot plate that supports the foot and allows bending of the posterior strut. The proximal cuff is a primary interface between the patient and the CDO and may influence comfort, preference, limb mechanics and loading, and effective stiffness of the CDO. The important role of the proximal cuff has not been examined. The purpose of this study is to determine the effects of CDO proximal cuff design on patient reported outcomes, limb mechanics and loading, and CDO mechanical characteristics.

Detailed description: Traumatic lower limb injuries often result in poor functional outcomes with long-term negative effects. Carbon fiber custom dynamic orthoses (CDOs) can improve outcomes by reducing pain, supporting the limb, and transferring forces around the limb through the CDO. CDOs consist of a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that stores and returns energy during gait, and a carbon fiber foot plate that supports the foot and allows bending of the posterior strut. The proximal cuff is a primary interface between the patient and the CDO and may influence comfort, preference, limb mechanics and loading, and effective stiffness of the CDO. Although CDOs are becoming more commonly prescribed following injury the evidence available to guide clinical practice remains limited. The important role of the proximal cuff has not been systematically examined.

The purpose of this study is to determine the effects of CDO proximal cuff design on patient reported outcomes, limb mechanics and loading, and CDO mechanical characteristics. Two groups of individuals will participate: individuals with post-traumatic osteoarthritis in the ankle and healthy individuals. Testing will occur without an orthosis and while wearing orthoses with four proximal cuff designs representative of currently available devices: 1) a rigid patellar tendon bearing (PTB) clamshell cuff secured using a mechanical ratcheting system, 2) a PTB shell with a fixed pivot point secured with Velcro, 3) a rigid clamshell cuff secured with Velcro, and 4) a semi-rigid cuff with a flexible outer layer secured with Velcro.

Eligibility criteria: PARTICIPANTS WITH PTOA:

Inclusion Criteria:

1. Ages 18-65.
2. Diagnosis of ankle PTOA.
3. Ability to walk 50 feet at a slow to moderate pace.
4. Ability to walk without a cane or crutch.
5. Ability to read and write in English and provide written informed consent.

Exclusion Criteria:

1. Diagnosis with a moderate or severe brain injury.
2. Diagnosis with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition...).
3. Ankle weakness as a result of spinal cord injury or nervous system pathology.
4. Nerve, muscle, bone, or other condition limiting function in the contralateral extremity.
5. Rheumatoid or inflammatory arthritis.
6. Necrosis of any bones in the foot or ankle.
7. Pain of 8/10 or greater during walking.
8. Surgery on study limb anticipated in the next 6 months.
9. Uncorrected visual or hearing impairments.
10. Require use of a stabilizing device (i.e. Ankle Foot Orthosis or Knee Orthosis...) to perform daily activities.
11. Pregnancy
12. Body mass index greater than 40.

HEALTHY ABLE-BODIED PARTICIPANTS:

Inclusion Criteria:

1. Ages 18-65.
2. Without current complaint of lower extremity pain, spine pain, open wounds or active infection.
3. Ability to hop without pain.
4. Ability to perform a full squat without pain.
5. Ability to read and write in English and provide written informed consent.

Exclusion Criteria:

1. Diagnosis with a moderate or severe brain injury.
2. Diagnosis with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition).
3. Medical conditions or injuries that have limited participation in work or exercise in the last 6 months.
4. Medical conditions of injuries limiting function for greater than 6 weeks.
5. Uncorrected visual or hearing impairments.
6. Use of an assistive device.
7. Pregnancy
8. Body mass index greater than 35.

Primary outcomes:
measure: Peak Plantar Force (total foot)
timeFrame: Baseline
measure: Plantar Force Impulse (total foot)
timeFrame: Baseline
measure: Peak Plantar Force (forefoot)
timeFrame: Baseline
measure: Plantar Force Impulse (forefoot)
timeFrame: Baseline
measure: Peak Plantar Force (midfoot)
timeFrame: Baseline
measure: Plantar Force Impulse (midfoot)
timeFrame: Baseline
measure: Peak Plantar Force (hindfoot)
timeFrame: Baseline
measure: Plantar Force Impulse (hindfoot)
timeFrame: Baseline
measure: Numerical Pain Rating Scale
timeFrame: Baseline
measure: PROMIS Patient Reported Outcomes for Physical Function
timeFrame: Baseline
measure: PROMIS Patient Reported Outcomes for Pain Interference
timeFrame: Baseline
measure: Participant Device Preference
timeFrame: Baseline
Secondary outcomes:
measure: Ankle Range of Motion
timeFrame: Baseline
measure: Peak Ankle Moment
timeFrame: Baseline
measure: Peak Ankle Power
timeFrame: Baseline
measure: Modified Socket Comfort Score (Comfort)
timeFrame: Baseline
measure: Modified Socket Comfort Score (Smoothness)
timeFrame: Baseline
Other outcomes:
measure: Center of Pressure Velocity Timing
timeFrame: Baseline
measure: Center of Pressure Velocity Magnitude
timeFrame: Baseline
measure: Tibialis Anterior Muscle Activity
timeFrame: Baseline
measure: Peroneus Longus Muscle Activity
timeFrame: Baseline
measure: Soleus Muscle Activity
timeFrame: Baseline
measure: Medial Gastrocnemius Muscle Activity
timeFrame: Baseline
measure: Semi-Structured Interview
timeFrame: Baseline
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Jason M Wilken, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: