Adults 18 to 45, any sex, with Adult ALL or Healthy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Knee Range of MotionPrimary· Baseline
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.
Group
Value
95% CI
NoCDO
69.1
± 4.7
CDO Only
67.0
± 5.3
Medial
66.4
± 4.7
Lateral
66.1
± 4.4
Peak Knee MomentPrimary· Baseline
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
Group
Value
95% CI
NoCDO
0.4
± 0.1
CDO Only
0.4
± 0.1
Medial
0.5
± 0.1
Lateral
0.3
± 0.1
Four Square Step Test (4SST)Primary· Baseline
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.
Group
Value
95% CI
NoCDO
5.6
± 0.9
CDO Only
5.8
± 1.0
Medial
5.7
± 1.0
Lateral
5.8
± 1.0
Numerical Pain Rating ScalePrimary· Baseline
Pain will be assessed using a standard 11-point numerical pain rating scale (NPRS), in which 0 = no pain and 10 = worst pain imaginable.
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.
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.
Group
Value
95% CI
CDO Only
6.9
± 1.9
Medial
6.7
± 2.1
Lateral
6.8
± 2.4
Ankle Range of MotionSecondary· Baseline
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.
Group
Value
95% CI
NoCDO
32.9
± 4.0
CDO Only
14.0
± 3.1
Medial
14.9
± 3.0
Lateral
15.0
± 3.2
Peak Ankle MomentSecondary· Baseline
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 normalize
Group
Value
95% CI
NoCDO
1.4
± 0.1
CDO Only
1.4
± 0.1
Medial
1.4
± 0.1
Lateral
1.4
± 0.1
Peak Ankle PowerSecondary· Baseline
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 t
Group
Value
95% CI
NoCDO
3.2
± 0.5
CDO Only
1.4
± 0.3
Medial
1.4
± 0.3
Lateral
1.5
± 0.3
Sit to Stand 5 Times (STS5)Secondary· Baseline
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.
Group
Value
95% CI
NoCDO
6.4
± 1.1
CDO Only
7.4
± 1.5
Medial
7.4
± 1.6
Lateral
7.2
± 1.7
Adverse events — posted to ClinicalTrials.gov
Time frame: Study participants were monitored/assessed for adverse advents throughout the duration of the study visit, up to 4 hours. Participants were also instructed to call or email the research team if any adverse events related to the study occurred after completion of the study visit, up to 6 months..
Reporting threshold: 0.05%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University of Iowa
Last refreshed: 30 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05209360.