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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Adult ALL
• Intervention / Treatment: Device: Medial or Lateral Wedge; Device: Carbon Fiber Custom Dynamic Orthosis

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52241
      • University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Testing Order: NoCDO, CDO, Lateral, Medial	Device: Medial or Lateral Wedge; 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.; Device: Carbon Fiber Custom Dynamic Orthosis; 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 Names: CDO
Experimental: Arm 2; Testing Order: NoCDO, CDO, Medial, Lateral	Device: Medial or Lateral Wedge; 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.; Device: Carbon Fiber Custom Dynamic Orthosis; 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 Names: CDO
Experimental: Arm 3; Testing Order: NoCDO, Medial, CDO, Lateral	Device: Medial or Lateral Wedge; 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.; Device: Carbon Fiber Custom Dynamic Orthosis; 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 Names: CDO
Experimental: Arm 4; Testing Order: NoCDO, Medial, Lateral, CDO	Device: Medial or Lateral Wedge; 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.; Device: Carbon Fiber Custom Dynamic Orthosis; 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 Names: CDO
Experimental: Arm 5; Testing Order: NoCDO, Lateral, Medial, CDO	Device: Medial or Lateral Wedge; 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.; Device: Carbon Fiber Custom Dynamic Orthosis; 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 Names: CDO
Experimental: Arm 6; Testing Order: NoCDO, Lateral, CDO, Medial	Device: Medial or Lateral Wedge; 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.; Device: Carbon Fiber Custom Dynamic Orthosis; 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 Names: CDO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Range of Motion	Participants completed a biomechanical gait analysis session in all testing conditions (NoCDO, CDO Only, Medial, Lateral). Retro-reflective markers were placed on the participants skin and 12 infrared motion capture cameras (120Hz, Vicon Ltd., Oxford, UK) were used to evaluate the motion of the lower limb as participants walked at a controlled walking speed based on leg length. A minimum of three gait cycles were used to calculate mean(SD) values. Sagittal plane knee range of motion (degrees) was measured throughout the gait cycle.	Baseline
Peak Knee Moment	Participants completed a biomechanical gait analysis session in all testing conditions (NoCDO, CDO Only, Medial, Lateral). Retro-reflective markers were placed on the participants skin and 12 infrared motion capture cameras (120Hz, Vicon Ltd., Oxford, UK) and three force plates (1200Hz, AMTI Inc., Watertown, MA) were used to evaluate the motion and loading of the lower limb as participants walked at a controlled walking speed based on leg length. A minimum of three gait cycles were used to calculate mean(SD) values. Peak knee valgus moment was measured during stance phase and normalized to the participants body weight (Nm/kg).	Baseline
Four Square Step Test (4SST)	The 4SST (s) is a standardized timed test of balance and agility. Participants start in the lower left quadrant of a Maltese cross setting on the floor and are timed as they move counterclockwise (forward, right, backward, left) and then clockwise (right, forward, left, backward) around the cross. Participants are instructed to move as quickly as they safely can.	Baseline
Numerical Pain Rating Scale	Pain will be assessed using a standard 11-point numerical pain rating scale (NPRS), in which 0 = no pain and 10 = worst pain imaginable.	Baseline
Modified Socket Comfort Score (Comfort)	Participants were asked to rate the comfort of each braced condition (CDO Only, Medial, Lateral) on a scale from 0-10 with 0 = most uncomfortable to 10 = most comfortable.	Baseline
Modified Socket Comfort Score (Smoothness)	Participants were asked to rate the smoothness of each braced condition (CDO Only, Medial, Lateral) on a scale from 0-10 with 0 = most smooth to 10 = least smooth.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ankle Range of Motion	Participants completed a biomechanical gait analysis session in all testing conditions (NoCDO, CDO Only, Medial, Lateral). Retro-reflective markers were placed on the participants skin and 12 infrared motion capture cameras (120Hz, Vicon Ltd., Oxford, UK) were used to evaluate the motion of the lower limb as participants walked at a controlled walking speed based on leg length. A minimum of three gait cycles were used to calculate mean(SD) values. Sagittal plane ankle range of motion (degrees) was measured throughout the gait cycle.	Baseline
Peak Ankle Moment	Participants completed a biomechanical gait analysis session in all testing conditions (NoCDO, CDO Only, Medial, Lateral). Retro-reflective markers were placed on the participants skin and 12 infrared motion capture cameras (120Hz, Vicon Ltd., Oxford, UK) and three force plates (1200Hz, AMTI Inc., Watertown, MA) were used to evaluate the motion and loading of the lower limb as participants walked at a controlled walking speed based on leg length. A minimum of three gait cycles were used to calculate mean(SD) values. Peak ankle plantarflexor moment was measured during stance phase and normalized to the participants body weight (Nm/kg).	Baseline
Peak Ankle Power	Participants completed a biomechanical gait analysis session in all testing conditions (NoCDO, CDO Only, Medial, Lateral). Retro-reflective markers were placed on the participants skin and 12 infrared motion capture cameras (120Hz, Vicon Ltd., Oxford, UK) and three force plates (1200Hz, AMTI Inc., Watertown, MA) were used to evaluate the motion and loading of the lower limb as participants walked at a controlled walking speed based on leg length. A minimum of three gait cycles were used to calculate mean(SD) values. Peak ankle push-off power was measured during stance phase and normalized to the participants body weight (W/kg).	Baseline
Sit to Stand 5 Times (STS5)	STS5 (s) is a well-established timed measure of lower limb muscle strength and power. Participants are timed as they stand up and sit down 5 times as fast as possible.	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Center of Pressure Velocity Timing	Timing of peak center of pressure velocity (percent stance) during gait.	Baseline
Center of Pressure Velocity Magnitude	Magnitude of peak center of pressure velocity (m/s) during gait.	Baseline
Semi-Structured Interview	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.	Baseline

Collaborators and Investigators

• Sponsor: University of Iowa
• Investigators: Principal Investigator: Jason M Wilken, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Biomechanics; Knee Osteoarthritis; Gait Analysis; Carbon Fiber; Ankle Foot Orthosis
• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Carbon Fiber
• Other Study ID Numbers: 202112360

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No