Brief Summary

This study is designed to support evidence-based practice and optimal care by evaluating how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influences outcomes following traumatic lower extremity injury.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

27mo left

Started Jul 2024

Longer than P75 for not_applicable

Geographic Reach

1 country

5 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.2 years study duration

Study Progress47%

Jul 2024Sep 2028

First Submitted

Initial submission to the registry

April 2, 2024

Completed

6 days until next milestone

First Posted

Study publicly available on registry

April 8, 2024

Completed

3 months until next milestone

Study Start

First participant enrolled

July 2, 2024

Completed

3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

January 15, 2026

Status Verified

December 1, 2025

Enrollment Period

3.2 years

First QC Date

April 2, 2024

Last Update Submit

January 13, 2026

Conditions

Foot Injury

Keywords

Ankle Foot OrthosisCarbon FiberGaitBiomechanicsPhysical Performance

Outcome Measures

Primary Outcomes (16)

PROMIS Physical Function
The Patient Reported Outcome Information System (PROMIS) Physical Function Computer Adaptive Test (CAT) is a computerized assessment measuring physical function. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents greater physical function than the population average. Larger scores are better.
Baseline
PROMIS Pain Interference
The Patient Reported Outcome Information System (PROMIS) Pain Interference Computer Adaptive Test (CAT) is a computerized assessment measuring pain interference. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents greater pain interference than the population average. Lower scores are better.
Baseline
OPUS Satisfaction with Device and Services
Satisfaction with device and services will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device and Services Score (11-55). Lower scores indicate a better outcome and more satisfaction with the CDO and accompanying services.
Baseline
Modified Socket Comfort Score - Comfort
Participants were asked to rate the comfort of each CDO configuration on a scale from 0-10 with 0 = most uncomfortable to 10 = most comfortable. Higher scores indicate more comfortable conditions, and are considered better.
Baseline
Modified Socket Comfort Score - Smoothness
Participants were asked to rate the smoothness of each CDO configuration on a scale from 0-10 with 0 = most smooth to 10 = least smooth. Lower scores indicate smoother conditions, and are considered better.
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. Lower scores are considered better.
Baseline
Preference - Ranked
The participant will be asked to rank order the conditions they have completed testing for at each visit: at the 3rd visit they will rank order their preference for using no orthosis or using the CDO in the first configuration, at the 4th visit they will rank order their preference for using no orthosis, using the CDO in the first configuration, and using the CDO in the second configuration, at the 5th visit they will rank order their preference for using no orthosis, using the CDO in the first configuration, using the CDO in the second configuration, and using the CDO in the third configuration.
Baseline
Preference - CDO Configuration
For each CDO configuration, participants will be asked to rank their preference on a scale from 0 (least preferred) to 10 (most preferred) for a number of questions concerning CDO use. Higher scores indicate higher preferences and are considered better.
Baseline
Four Square Step Test (seconds)
The 4SST (seconds) 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. Lower times indicate faster completion of the test and are considered better results.
Baseline
Sit to Stand 5 Times (seconds)
STS5 (seconds) 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. Lower scores indicate a faster time to complete the test and are considered better results.
Baseline
Center of Pressure Velocity Magnitude (m/s)
The center of pressure (CoP) is the centroid of the forces acting on the foot during gait. The magnitude of the peak center of pressure velocity (m/s) is the fastest the CoP moves during gait.
Baseline
Center of Pressure Velocity Timing (%stance)
The center of pressure (CoP) is the centroid of the forces acting on the foot during gait. The timing of the peak center of pressure velocity, is the percent of the stance phase (%stance) where the CoP is moving fastest during gait.
Baseline
Ankle Zero Moment Crossing (%stance)
The ankle zero moment crossing is the point during the stance phase of gait (%stance) where the ankle moment transitions from a dorsiflexion to a plantarflexion moment.
Baseline
Peak Ankle Dorsiflexion (degree)
Participants completed a biomechanical gait analysis session. Sagittal plane peak ankle joint dorsiflexion angle (degree) that occurs late in the stance phase of gait.
Baseline
Peak Ankle Plantarflexion Moment (Nm/kg)
Participants completed a biomechanical gait analysis session. Sagittal plane peak ankle joint plantarflexion moment normalized to participant body weight (Nm/kg) that occurs late in the stance phase of gait.
Baseline
Peak Ankle Push-Off Power (W/kg)
Participants completed a biomechanical gait analysis session. Sagittal plane peak ankle joint power normalized to body weight (W/kg) occurs late in the stance phase of gait.
Baseline

Secondary Outcomes (3)

PROMIS Satisfaction with Participation in Social Activities
Baseline
PROMIS Satisfaction with Participation in Discretionary Social Activities
Baseline
PROMIS Depression
Baseline

Other Outcomes (1)

Ankle Range of Motion (degrees)
Baseline

Study Arms (6)

NoCDO, A, B, C

EXPERIMENTAL

Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration A, CDO configuration B, and finally CDO configuration C.