N/A
N=20
Heel Wedges and Carbon Fiber Custom Dynamic Orthoses to Control Knee Biomechanics
Adult ALL · Healthy
Bottom Line
View on ClinicalTrials.gov: NCT05209360 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Knee Range of Motion — 69.1; 67.0; 66.4; 66.1 degrees
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Medial or Lateral Wedge (Device); Carbon Fiber Custom Dynamic Orthosis (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Iowa
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knee Range of Motion |
69.1; 67.0; 66.4; 66.1 | — |
| PRIMARY Peak Knee Moment |
0.4; 0.4; 0.5; 0.3 | — |
| PRIMARY Four Square Step Test (4SST) |
5.6; 5.8; 5.7; 5.8 | — |
| PRIMARY Numerical Pain Rating Scale |
0.0; 0.3; 0.6; 0.3 | — |
| PRIMARY Modified Socket Comfort Score (Comfort) |
7.4; 6.7; 6.7 | — |
| PRIMARY Modified Socket Comfort Score (Smoothness) |
6.9; 6.7; 6.8 | — |
| SECONDARY Ankle Range of Motion |
32.9; 14.0; 14.9; 15.0 | — |
| SECONDARY Peak Ankle Moment |
1.4; 1.4; 1.4; 1.4 | — |
| SECONDARY Peak Ankle Power |
3.2; 1.4; 1.4; 1.5 | — |
| SECONDARY Sit to Stand 5 Times (STS5) |
6.4; 7.4; 7.4; 7.2 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05209360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.