Iterative Design of Custom Dynamic Orthoses
Condition: Adult ALL; Healthy
Study type: Interventional

Summary: 
      The proposed study evaluates the effect of carbon fiber brace design on forces across the
      ankle joint. It is expected that carbon fiber braces can be designed to reduce forces in the
      ankle. In this study, brace geometry will be varied to determine how these changes influence
      the forces experienced by ankle cartilage. The purpose of this study is to refine a
      pre-existing musculoskeletal model and finalize the procedures for inputting multiple data
      sources into the model to evaluate ankle articular contact stresses.
    

Detailed description: 
      The purpose of this study is to refine a pre-existing musculoskeletal model and finalize the
      procedures for inputting multiple data sources into the model to evaluate ankle articular
      contact stresses.

      Healthy adult participants will complete testing using three generic sized carbon fiber
      custom dynamic orthoses (CDOs) and with no CDO. Participants will be blinded to the design
      variation of each device and will only know them as CDO-A, CDO-B, or CDO-C. Testing will be
      completed under 4 conditions: No-CDO, CDO-A, CDO-B, CDO-C, with each bracing condition
      (A/B/C) representing a CDO design variant. Physical performance measures will incorporate
      tests of agility, speed, and lower limb power to ensure that changes to device design do not
      negatively affect physical function. Questionnaires will be used to evaluate participants'
      current and desired activity level, pain with and without CDO use, satisfaction with the
      devices, perception of comfort and smoothness between devices, and preference between CDOs.
      Semi-structured interviews will be completed to fully capture the participant's perspective.
      Lower limb forces and motion will be assessed using a computerized motion capture system and
      force plates in the floor. Forces between the foot and CDO will be measured using force
      sensing insoles, and muscle activity data will be collected using surface electromyography.
      Devices will be mechanically tested, and participant demographic and anthropometric data will
      be recorded.

      The information obtained from this study will help refine the musculoskeletal model data
      input methods to be used in future studies. The knowledge that will be gained from this
      investigation has the potential to substantially improve the long-term efficacy and
      efficiency of the musculoskeletal model and help improve ankle foot orthosis
    

Intervention name(s): Carbon Fiber Custom Dynamic Orthosis (CDO)
Intervention type(s): Device
Intervention description(s): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.
Other intervention name(s): Ankle Foot Orthosis
Intervention MeSH terms: Carbon Fiber
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All participants will use three generic sized carbon fiber custom dynamic orthoses (CDOs). Each CDO will differ from the others in design and will be labeled as CDO-A, CDO-B and CDO-C. Participants will be randomly assigned to one of six CDO testing sequences (ABC, ACB, BCA, BAC, CAB, CBA) to prevent testing order from influencing study results.
Masking: Single (Participant)
Primary purpose: Other
Keywords: Gait Analysis; Ankle Foot Orthosis; Carbon Fiber; Biomechanics