Trauma Injury
Conditions
Keywords
carbon fiber, traumatic injury, ankle foot orthosis
Brief summary
Carbon fiber custom dynamic orthoses (CDOs) improve function, reduce pain, and offload the foot and ankle. CDOs include a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that bends to store and return energy, and a semi-rigid carbon fiber footplate. The purpose of this study is to determine the effect of CDO use and CDO footplate stiffness on foot loading, limb mechanics, pain, and comfort.
Detailed description
Carbon fiber custom dynamic orthoses (CDOs) have been used to improve function, reduce pain, and offload the foot and ankle for individuals with a number of conditions affecting the lower extremity.\[1-3\] CDOs consist of a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that bends to store and return energy during mid to late stance, a semi-rigid carbon fiber footplate, and, in some cases, a foam heel wedge placed in the shoe. Studies have previously investigated the effects of design characteristics on gait biomechanics and foot loading, however, the effect of foot plate stiffness on resulting foot loading is unknown. The purpose of this study is to determine the effect of CDO use and CDO footplate stiffness on foot loading, limb mechanics, pain, and comfort. In this study, forces acting under the foot will be measured using wireless Loadsol insoles (Novel GMBH, St. Paul, MN) and limb mechanics will be measured using motion capture cameras and force plates as participants walk without an orthosis (NoCDO), with a CDO, and with a CDO plus added carbon fiber stiffening inserts (1/2) at a controlled walking speed. Participants will be provided a heel lift for the contralateral limb to prevent leg length discrepancies during walking if necessary. After walking in each condition, participants will complete questionnaires concerning pain and orthosis comfort.
Interventions
The carbon fiber custom dynamic orthosis (CDO) used in this study will consist of a semi-rigid carbon fiber footplate, a carbon fiber posterior strut, and a proximal cuff that wraps around the leg below the knee.
DEVICECarbon Fiber Footplate
One or two additional full-length carbon fiber footplates will be placed under the CDO footplate to increase the effective footplate stiffness
Sponsors
University of Iowa
Jason Wilken
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Intervention model description
In this study participants will walk without an orthosis (NoCDO) and with a generic sized CDO with three different levels of footplate stiffness at a controlled speed (CDO, 1CFPlate, 2CFPlate). Testing order of the CDO conditions will be randomized to prevent influence of testing order.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Between the ages of 18 and 65 * Healthy without current complaint of lower extremity pain, spine pain, open wounds or active infections, or medical or neuromusculoskeletal disorders that have limited their participation in work or exercise in the last 6 months * Able to hop without pain * Able to perform a full squat without pain * Ability to read and write in English and provide written informed consent * Ability to fit in a generic sized CDO
Exclusion criteria
* Diagnosed with a moderate or severe brain injury * Lower extremity injury resulting in surgery or limiting function for greater than 6 weeks * Injuries that would limit performance in this study * Diagnosed with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition) * Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing * Require use of an assistive device * Unhealed wounds (cuts/abrasions) that would prevent AFO use * BMI \> 40 * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Ankle Power | Baseline | Peak sagittal plane ankle push-off power (W/kg) during gait. |
| Peak Forefoot Force | Baseline | Plantar forces (N) will be measured across the forefoot (distal 40% of sensor). |
| Forefoot Force Impulse | Baseline | Plantar force impulse (Ns) across the forefoot (distal 40% of sensor) will be calculated using the integral of the force over the stance phase. |
| Peak Hindfoot Force | Baseline | Plantar forces (N) will be measured across the hindfoot (proximal 30% sensor). |
| Hindfoot Force Impulse | Baseline | Plantar force impulse (Ns) across the hindfoot (proximal 30% sensor) will be calculated using the integral of the force over the stance phase. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Ankle Dorsiflexion | Baseline | Peak ankle dorsiflexion (degrees) during gait. |
| Peak Ankle Plantarflexion | Baseline | Peak ankle plantarflexion (degrees) during gait. |
| Ankle Range of Motion | Baseline | Range of ankle motion (degrees) during gait. |
| Peak Ankle Plantarflexion Moment | Baseline | Peak ankle plantarflexion moment (Nm/kg) during gait. |
| Numerical Pain Rating Scale | Baseline | Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable |
| Modified Socket Comfort Score (Comfort) | Baseline | Comfort scores range from 0 = most uncomfortable to 10= most comfortable |
| Peak Ankle Dorsiflexion Moment | Baseline | Peak ankle dorsiflexion moment (Nm/kg) during gait. |
| Peak Midfoot Force | Baseline | Plantar forces (N) will be measured across the midfoot (middle 30% of sensor). |
| Midfoot Force Impulse | Baseline | Plantar force impulse (Ns) across the midfoot (middle 30% of sensor) will be calculated using the integral of the force over the stance phase. |
| Peak Total Foot Force | Baseline | Plantar forces (N) will be measured across the total foot (100% of sensors). |
| Total Foot Force Impulse | Baseline | Plantar force impulse (Ns) across the total foot (100% of sensors) will be calculated using the integral of the force over the stance phase. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Modified Socket Comfort Score (Smoothness) | Baseline | Smoothness scores range from 0 = least smooth to 10 = most smooth |
Countries
United States
Contacts
Primary ContactJason M Wilken, PT, PhD
Backup ContactKirsten M Anderson, PhD
Outcome results
None listed