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

NCT05209360 | Completed Results FDA Device

• 1 other identifier: 202112360
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adult ALL; Healthy

Keywords

Gait Analysis; Ankle Foot Orthosis; Carbon Fiber; Biomechanics; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Ankle Range of Motion

  Baseline

• Peak Ankle Moment

  Baseline

• Peak Ankle Power

  Baseline

• Sit to Stand 5 Times (STS5)

  Baseline

Other Outcomes (3)

• Semi-Structured Interview

  Baseline

• Center of Pressure Velocity Timing

  Baseline

• Center of Pressure Velocity Magnitude

  Baseline

Study Arms (6)

Arm 1

EXPERIMENTAL

Testing Order: NoCDO, CDO, Lateral, Medial

Device: Medial or Lateral Wedge; Device: Carbon Fiber Custom Dynamic Orthosis

Arm 2

EXPERIMENTAL

Testing Order: NoCDO, CDO, Medial, Lateral

Device: Medial or Lateral Wedge; Device: Carbon Fiber Custom Dynamic Orthosis

Arm 3

EXPERIMENTAL

Testing Order: NoCDO, Medial, CDO, Lateral

Device: Medial or Lateral Wedge; Device: Carbon Fiber Custom Dynamic Orthosis

Arm 4

EXPERIMENTAL

Testing Order: NoCDO, Medial, Lateral, CDO

Device: Medial or Lateral Wedge; Device: Carbon Fiber Custom Dynamic Orthosis

Arm 5

EXPERIMENTAL

Testing Order: NoCDO, Lateral, Medial, CDO

Device: Medial or Lateral Wedge; Device: Carbon Fiber Custom Dynamic Orthosis

Arm 6

EXPERIMENTAL

Testing Order: NoCDO, Lateral, CDO, Medial

Device: Medial or Lateral Wedge; Device: Carbon Fiber Custom Dynamic Orthosis

Interventions

Medial or Lateral Wedge DEVICE

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.

Arm 1; Arm 2; Arm 3; Arm 4; Arm 5; Arm 6

Carbon Fiber Custom Dynamic Orthosis DEVICE

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.

Also known as: CDO

Arm 1; Arm 2; Arm 3; Arm 4; Arm 5; Arm 6

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52241, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

\[Not Specified\]

Results Point of Contact

• Title: Jason M Wilken, PT, PhD
• Organization: The University of Iowa

jason-wilken@uiowa.edu

319-335-6857

Study Officials

• Jason M Wilken

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the testing conditions to the greatest extent possible.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Collaborative Research and Development, Associate Professor

Model Details: 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)

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 26, 2022
• Study Start: May 9, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 30, 2024
• Results First Posted: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)