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Recruiting NCT06710119

Effect of Custom Dynamic Orthoses on Forefoot Loading

No phase Interventional Lower Extremity Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Visual Feedback.
Who it may be relevant to
Registry conditions: Lower Extremity Injuries. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

This study is designed to evaluate the effects of initial accommodation, CDO related training, and take-home use on foot loading during gait. In this study, adult participants who experienced an injury below the knee and require a CDO will walk without the CDO, then with the CDO following initial prescription, after training with or without visual force feedback, and after additional take-home use of the CDO. Participants will be randomized to to training with or without visual feedback of foot loading forces.

Wireless force measuring sensors will be used to measure forces under the foot with and without the CDO at each time point. Participants will complete questionnaires to assess and compare various patient outcomes (e.g. pain, quality of life, comfort, satisfaction, and preference).

Interventions

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

Primary outcome measures

  • Peak Plantar Force (Forefoot) [Time frame: Baseline]
  • Plantar Force Impulse (Forefoot) [Time frame: Baseline]
Secondary outcome measures (6)
  • Peak Plantar Force (Midfoot) [Time frame: Baseline]
  • Plantar Force Impulse (Midfoot) [Time frame: Baseline]
  • Peak Plantar Force (Hindfoot) [Time frame: Baseline]
  • Plantar Force Impulse (Hindfoot) [Time frame: Baseline]
  • Peak Plantar Force (Total Foot) [Time frame: Baseline]
  • Plantar Force Impulse (Total Foot) [Time frame: Baseline]

Eligibility criteria

Patient Inclusion criteria

  • Ages: 18-65
  • 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
  • Ability to walk at a slow to moderate pace
  • Able to read and write in English and provide written informed consent

Patient Exclusion criteria

  • 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)
  • Nerve, muscle, bone, or other condition limiting function of the contralateral extremity
  • BMI greater than 40
  • Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing
  • Pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 2 centers
  • University of Iowa — Iowa City
  • Cornerstone Prosthetics and Orthotics — Everett

Identifiers

NCT: NCT06710119 · 202207100

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗