Effect of Custom Dynamic Orthoses on Forefoot Loading

Conditions

• Lower Extremity Injuries

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Visual Feedback — OTHER
  Visual feedback of foot loading during gait.

Study Details

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.

Key Dates

Start date

Jun 18, 2025

Status verified

Dec 2025

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• No Intervention: No Visual Feedback
  Participants will receive typical accommodation training after being prescribed the CDO.
• Active Comparator: Provided Visual Feedback
  Participants will receive typical accommodation training with additional visual feedback after being prescribed the CDO.

Primary Outcome Measure

Peak Plantar Force (Forefoot) [ Time Frame: Baseline ]

Central Contacts

• Jason M Wilken, PT, PhD
  319-335-6857
  [email protected]
• Kirsten M Anderson, PhD
  319-353-0431
  [email protected]

Locations (2)

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