Effect of Custom Dynamic Orthoses on Forefoot Loading

ConditionLower Extremity Injuries

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorUniversity of Iowa

About this trial

The proposed study is designed to evaluate how foot loading changes during initial accommodation to a carbon fiber custom dynamic orthosis (CDO), after targeted training with or without visual feedback of foot loading, and after take-home use of the CDO. This study will quantify initial offloading associated with CDO use and determine if visual feedback of foot loading and additional take-home use of the CDO can further reduce forces, as orthotists work to provide CDOs to patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sustained a function limiting injury below the knee, requiring a carbon fiber custom dynamic orthosis

Shoe size between women's 8 and 13.5 or men's 6.5 and 13

Any of the following: weakness of ankle plantarflexors (<4/5 on MMT), limited pain free ankle motion (DF<10deg or PF<20deg), mechanical pain with loading onto hindfoot/midfoot/forefoot (>4/10 on verbal numeric pain rating scale), ankle or hindfoot fusion, candidate for ankle or hindfoot fusion, candidate for amputation secondary to ankle/foot impairment

Ability to walk 25 feet without using a cane or crutch

Disqualifiers

Pain > 9/10 while walking

Ankle weakness as a result of spinal cord injury or central nervous system pathology

AFO or CDO prescription that includes a knee brace or goes up to thigh

Medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, heart condition, clotting disorder, lung condition, stroke, vestibular disorder)

Trial design

Design model

Parallel

Treatments tested in this trial

Visual Feedback
Other intervention
Visual feedback of foot loading during gait.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: No Visual FeedbackNo intervention 0 interventions

Group B: Provided Visual FeedbackActive comparator 1 intervention

Trial outcomes

Primary outcomes

Peak Plantar Force (Forefoot)

Maximum force (N) collected from the forefoot (distal 40% of sensor) during gait.

Time frame

Baseline

Plantar Force Impulse (Forefoot)

Plantar force impulse (Ns) across the forefoot (distal 40% of sensor) will be calculated using the integral of the force over the stance phase as participants walk.

Time frame

Baseline

Secondary outcomes

Peak Plantar Force (Midfoot)

Maximum force (N) collected from the midfoot (middle 30% of sensor) during gait.

Time frame

Baseline

Plantar Force Impulse (Midfoot)

Plantar force impulse (Ns) across the midfoot (middle 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk.

Time frame

Baseline

Peak Plantar Force (Hindfoot)

Maximum force (N) collected from the hindfoot (proximal 30% of sensor) during gait.

Time frame

Baseline

Plantar Force Impulse (Hindfoot)

Plantar force impulse (Ns) across the hindfoot (proximal 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk.

Time frame

Baseline

Other outcomes

Modified Socket Comfort Score (Comfort)

Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.

Time frame

Baseline

Modified Socket Comfort Score (Smoothness)

Smoothness scores range from 0 = least smooth to 10 = most smooth.

Time frame

Baseline

Numerical Pain Rating Scale

Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.

Time frame

Baseline

Patient Reported Outcome Measurement Information System (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 more of the measured variable than the population average.

Time frame

Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Iowa

Lead sponsor

Cornerstone Clinics, Everett, WA

Collaborator

Source ClinicalTrials.gov

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