University of Iowa
Iowa City, Iowa, 52241, United States
Location status: Recruiting
Location contact
Jason M Wilken, PT, PhD
CONTACT
Kirsten M Anderson, PhD
CONTACT
NCT Number: NCT07312032
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Iowa City, Iowa, 52241, United States
Location status: Recruiting
Jason M Wilken, PT, PhD
CONTACT
Kirsten M Anderson, PhD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: ankle foot orthosis
One or two additional full-length carbon fiber footplates will be placed under the CDO footplate to increase the effective footplate stiffness
Time frame: Baseline
Plantar forces (N) will be measured across the forefoot (distal 40% of sensor).
Time frame: 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.
Time frame: Baseline
Plantar forces (N) will be measured across the hindfoot (proximal 30% sensor).
Time frame: Baseline
Plantar force impulse (Ns) across the hindfoot (proximal 30% sensor) will be calculated using the integral of the force over the stance phase.
Time frame: Baseline
Peak sagittal plane ankle push-off power (W/kg) during gait.
Time frame: Baseline
Plantar forces (N) will be measured across the midfoot (middle 30% of sensor).
Time frame: 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.
Time frame: Baseline
Plantar forces (N) will be measured across the total foot (100% of sensors).
Time frame: 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.
Time frame: Baseline
Peak ankle dorsiflexion (degrees) during gait.
Time frame: Baseline
Peak ankle plantarflexion (degrees) during gait.
Time frame: Baseline
Range of ankle motion (degrees) during gait.
Time frame: Baseline
Peak ankle dorsiflexion moment (Nm/kg) during gait.
Time frame: Baseline
Peak ankle plantarflexion moment (Nm/kg) during gait.
Time frame: Baseline
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable
Time frame: Baseline
Comfort scores range from 0 = most uncomfortable to 10= most comfortable
Time frame: Baseline
Smoothness scores range from 0 = least smooth to 10 = most smooth
Contact information is provided by the study sponsor or research team.
Jason M Wilken, PT, PhD
CONTACT
Kirsten M Anderson, PhD
CONTACT
Jason Wilken
Other
Acronym: CDOCFPlate
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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