Heel Wedges and Carbon Fiber Custom Dynamic Orthoses to Control Knee Biomechanics

Overview

The proposed study evaluates the effect of medial lateral wedge and carbon fiber custom dynamic orthosis (CDO) use on lower limb force and motion during walking. Previous work has used foam heel wedges to alter CDO alignment and resulting lower limb mechanics, and medial lateral foam wedges have been successfully used to treat unilateral knee osteoarthritis. In this study, medial 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 with no CDO. The proposed study will provide evidence that can be used by physicians when treating knee osteoarthritis.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 2022

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-lateral wedge use on biomechanics during gait in an effort to reduce unilateral knee compartment loading. It has been shown previously that use of a heel wedge with a CDO can affect gait biomechanics and medial-lateral wedging has been successfully used in treatment of knee osteoarthritis. Additional support and restriction of motion at the ankle associated with CDO use may emphasize results seen at the knee with medial-lateral wedging. Therefore, the proposed effort is designed to evaluate how different medial-lateral wedges placed under a CDO influence knee biomechanics during gait. The proposed study will provide evidence that can be used by physicians when treating knee osteoarthritis. In this research study, pilot 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 order 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 device and wedge don't negatively affect physical function. Questionnaires will be used to evaluate participants' pain and perception of comfort and smoothness for each condition.

Interventions

  • Device: Medial or Lateral Wedge
    • A medial lateral wedge that runs along the length of the foot, the tall side of the wedge will be placed either on the medial or lateral aspect of the shoe during the Medial and Lateral conditions
  • Device: Carbon Fiber Custom Dynamic Orthosis
    • A medical device with a proximal cuff wrapping 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.

Arms, Groups and Cohorts

  • Experimental: Arm 1
    • Testing Order: NoCDO, CDO, Lateral, Medial
  • Experimental: Arm 2
    • Testing Order: NoCDO, CDO, Medial, Lateral
  • Experimental: Arm 3
    • Testing Order: NoCDO, Medial, CDO, Lateral
  • Experimental: Arm 4
    • Testing Order: NoCDO, Medial, Lateral, CDO
  • Experimental: Arm 5
    • Testing Order: NoCDO, Lateral, Medial, CDO
  • Experimental: Arm 6
    • Testing Order: NoCDO, Lateral, CDO, Medial
  • Experimental: Arm 7
    • Testing Order: CDO, NoCDO, Medial, Lateral
  • Experimental: Arm 8
    • Testing Order: CDO, NoCDO, Lateral, Medial
  • Experimental: Arm 9
    • Testing Order: CDO, Medial, NoCDO, Lateral
  • Experimental: Arm 10
    • Testing Order: CDO, Medial, Lateral, NoCDO
  • Experimental: Arm 11
    • Testing Order: CDO, Lateral, Medial, NoCDO
  • Experimental: Arm 12
    • Testing Order: CDO, Lateral, NoCDO, Medial
  • Experimental: Arm 13
    • Testing Order: Medial, NoCDO, Lateral, CDO
  • Experimental: Arm 14
    • Testing Order: Medial, NoCDO, CDO, Lateral
  • Experimental: Arm 15
    • Testing Order: Medial, CDO, NoCDO, Lateral
  • Experimental: Arm 16
    • Testing Order: Medial, CDO, Lateral, NoCDO
  • Experimental: Arm 17
    • Testing Order: Medial, Lateral, CDO, NoCDO
  • Experimental: Arm 18
    • Testing Order: Medial, Lateral, NoCDO, CDO
  • Experimental: Arm 19
    • Testing Order: Lateral, NoCDO, CDO, Medial
  • Experimental: Arm 20
    • Testing Order: Lateral, NoCDO, Medial, CDO
  • Experimental: Arm 21
    • Testing Order: Lateral, CDO, Medial, NoCDO
  • Experimental: Arm 22
    • Testing Order: Lateral, CDO, NoCDO, Medial
  • Experimental: Arm 23
    • Testing Order: Lateral, Medial, NoCDO, CDO
  • Experimental: Arm 24
    • Testing Order: Lateral, Medial, CDO, NoCDO

Clinical Trial Outcome Measures

Primary Measures

  • Ankle Range of Motion
    • Time Frame: Baseline
    • Ankle range of motion (degrees) during gait.
  • Knee Range of Motion
    • Time Frame: Baseline
    • Knee range of motion (degrees) during gait.
  • Peak Ankle Moment
    • Time Frame: Baseline
    • Peak ankle moment (Nm/kg) during gait.
  • Peak Knee Moment
    • Time Frame: Baseline
    • Peak knee moment (Nm/kg) during gait.
  • Peak Ankle Power
    • Time Frame: Baseline
    • Peak ankle power (W/kg) during gait.
  • Center of pressure velocity timing
    • Time Frame: Baseline
    • Timing of peak center of pressure velocity (percent stance) during gait.
  • Center of pressure velocity magnitude
    • Time Frame: Baseline
    • Magnitude of peak center of pressure velocity (m/s) during gait.

Secondary Measures

  • Four Square Step Test (4SST)
    • Time Frame: Baseline
    • The 4SST (s) is a standardized timed test of balance and agility.
  • Sit to Stand 5 Times (STS5)
    • Time Frame: Baseline
    • STS5 (s) is a well-established timed measure of lower limb muscle strength and power. Participants are instructed to stand up and sit down 5 times as fast as possible.
  • Modified Socket Comfort Score (Comfort and Smoothness)
    • Time Frame: Baseline
    • Comfort scores range from 0 = most uncomfortable to 10 = most comfortable, and from 0 = least smooth to 10 = most smooth.
  • Numerical Pain Rating Scale
    • 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.
  • Semi-Structured Interview
    • Time Frame: Baseline
    • Semi-structured interviews will also be used to fully capture the patients’ perspectives, experience, and opinions associated with the testing conditions they experienced as part of the study.

Participating in This Clinical Trial

Inclusion Criteria

  • Between the ages of 18 and 45 – 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 speak and understand English Exclusion Criteria:

  • Medical or neuromusculoskeletal disorders that have limited their participation in work or exercise in the last 6 months – 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) – Uncorrected visual or hearing impairment(s) – Require use of an assistive device – Unhealed wounds (cuts/abrasions) that would prevent CDO use – BMI > 35 – Pregnancy – Per participant self-report. Due to the expected small number of pregnant individuals, and resulting inability to account for its effect on resulting outcomes participants will be withdrawn from the study

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Iowa
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jason Wilken, Director of Collaborative Research and Development, Associate Professor – University of Iowa
  • Overall Official(s)
    • Jason M Wilken, Principal Investigator, University of Iowa
  • Overall Contact(s)
    • Jason M Wilken, 3193356857, jason-wilken@uiowa.edu

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