Heel Wedges and Carbon Fiber Custom Dynamic Orthoses to Control Knee Biomechanics
Condition: Adult ALL; Healthy
Study type: Interventional

Summary: 
      The proposed study evaluates the effect of medial and lateral wedges and carbon fiber custom
      dynamic orthoses (CDOs) on lower limb forces and motion during walking. Previous work has
      used foam wedges of different stiffness and height placed under the heel to alter CDO
      alignment and alter lower limb mechanics. Medial or lateral wedges have been used by
      individuals with unilateral knee osteoarthritis in effort to reduce knee loading. In this
      study, medial and lateral wedges will be placed in participants shoes, with the tall side of
      the wedge placed on the medial or lateral aspect of the shoes, and participants will walk at
      controlled and self-selected speeds and complete physical performance measures. Participants
      will also walk without a CDO. The proposed study will provide evidence that can be used by
      physicians when treating knee osteoarthritis.
    

Detailed description: 
      The primary purpose of this line of research is to investigate the effects of combined carbon
      fiber custom dynamic orthosis (CDO) and medial or lateral wedge use on biomechanics during
      gait in effort to reduce unilateral knee compartment loading. The medial or lateral wedges
      are composed of foam, run the length of the foot, and will be placed so the tall side of the
      wedge is on the medial (Medial Wedge) or lateral (Lateral Wedge) aspect of the shoe to
      preferentially load the medial and lateral edges of the foot respectively. The use of medial
      and lateral wedges to treat unilateral knee osteoarthritis (OA) has been studied previously,
      generally without combined use of a foot and ankle brace such as a CDO. Previous work has
      demonstrated that foam wedges, of different height and stiffness, placed under the heel of a
      CDO affects sagittal plane gait biomechanics, including ankle plantarflexion and knee
      extension moments. The additional support and restriction of motion at the ankle associated
      with CDO use may emphasize results seen at the knee with medial or lateral wedging.
      Therefore, the proposed effort is designed to evaluate how different medial or lateral wedges
      placed under a CDO influence frontal plane knee biomechanics during level over-ground gait
      and physical performance during tests of agility, speed, and lower limb power. The proposed
      study will provide evidence that can be used by physicians when treating knee osteoarthritis.

      In this research study, data will be collected from a cohort of healthy adult participants
      with no history of lower limb injuries or functional deficits. Participants will be evaluated
      using a series of study measures under each of the four conditions; without a brace (NoCDO),
      with a brace and no wedge (CDO), with a brace and a medial wedge placed in the shoe (Medial),
      and with a brace and a lateral wedge placed in the shoe (Lateral). The wedge will be placed
      in a medial and lateral position to determine effectiveness of combined wedging and CDO use
      in treating both medial and lateral knee OA. Testing will be randomized for each participant.
      Participants will walk on a level-ground walkway at self-selected and controlled speeds.
      Physical performance measures will incorporate tests of agility, speed, and lower limb power
      to ensure that the CDO and wedge do not negatively affect physical function. Questionnaires
      will be used to evaluate participants' pain and perception of comfort and smoothness for each
      testing condition.
    

Intervention name(s): Medial or Lateral Wedge; Carbon Fiber Custom Dynamic Orthosis
Intervention type(s): Device; Device
Intervention description(s): A foam wedge that is placed inside the shoe under the CDO, that runs along the length of the foot. The tall side of the wedge will be placed on the medial (Medial Wedge) or lateral (Lateral Wedge) aspect of the shoe to preferentially load the medial or lateral side of the foot.; A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
Other intervention name(s): CDO
Intervention MeSH terms: Carbon Fiber
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will be evaluated without a CDO (NoCDO), with a CDO and no wedge (CDO), with a CDO and a wedge placed on the medial aspect of the shoe (Medial), and with a CDO and a wedge placed on the lateral aspect of the shoe (Lateral)
Masking: Single (Participant)
Primary purpose: Other
Keywords: Gait Analysis; Ankle Foot Orthosis; Carbon Fiber; Biomechanics; Knee Osteoarthritis