The Effects of AFO Heel Height and Stiffness on Gait

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
University of Iowa
Study ID
NCT04800484
Status
Recruiting
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Conditions

  • Musculoskeletal Diseases
  • Musculoskeletal Injury
  • Peripheral Nervous System Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Tall Soft — DEVICE
    Tall heel wedge made of soft foam
  • Tall Firm — DEVICE
    Tall heel wedge made of firm foam
  • Short Soft — DEVICE
    Short heel wedge made of soft foam
  • Short Firm — DEVICE
    Short heel wedge made of firm foam

Study Details

The proposed study evaluates the effect of ankle foot orthosis (AFO) heel height and stiffness on the forces and motion of the lower limb during over-ground walking in individuals who use an AFO for daily walking. Previous studies suggest that heel height and stiffness effect limb loading, but these data and the analysis techniques applied are limited. In this study, heel cushions with different height and stiffness's (4 conditions) will be placed in participants shoes and they will walk at controlled and self-selected speeds. Participants will also walk with their AFO as configured prior to enrollment, and with no AFO if possible. The proposed study will provide evidence that can be used by clinicians and researchers to align braces that most effectively improve function during every-day walking.

Key Dates

Start date
Nov 7, 2019
Status verified
Dec 2025
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Arm 1:
    Testing Order: Clinical AFO, Tall Soft, Tall Firm, Short Soft, Short Firm, NoAFO
  • Experimental: Arm 2:
    Testing Order: Clinical AFO, Tall Soft, Tall Firm, Short Firm, Short Soft, NoAFO
  • Experimental: Arm 3:
    Testing Order: Clinical AFO, Tall Soft, Short Soft, Tall Firm, Short Firm, NoAFO
  • Experimental: Arm 4:
    Testing Order: Clinical AFO, Tall Soft, Short Soft, Short Firm, Tall Firm, NoAFO
  • Experimental: Arm 5:
    Testing Order: Clinical AFO, Tall Soft, Short Firm, Tall Firm, Short Soft, NoAFO
  • Experimental: Arm 6:
    Testing Order: Clinical AFO, Tall Soft, Short Firm, Short Soft, Tall Firm, NoAFO
  • Experimental: Arm 7:
    Testing Order: Clinical AFO, Tall Firm, Tall Soft, Short Soft, Short Firm, NoAFO
  • Experimental: Arm 8:
    Testing Order: Clinical AFO, Tall Firm, Tall Soft, Short Firm, Short Soft, NoAFO
  • Experimental: Arm 9:
    Testing Order: Clinical AFO, Tall Firm, Short Soft, Tall Soft, Short Firm, NoAFO
  • Experimental: Arm 10:
    Testing Order: Clinical AFO, Tall Firm, Short Soft, Short Firm, Tall Soft, NoAFO
  • Experimental: Arm 11:
    Testing Order: Clinical AFO, Tall Firm, Short Firm, Tall Soft, Short Soft, NoAFO
  • Experimental: Arm 12:
    Testing Order: Clinical AFO, Tall Firm, Short Firm, Short Soft, Tall Soft, NoAFO
  • Experimental: Arm 13:
    Testing Order: Clinical AFO, Short Soft, Tall Soft, Short Firm, Tall Firm, NoAFO
  • Experimental: Arm 14:
    Testing Order: Clinical AFO, Short Soft, Tall Soft, Tall Firm, Short Firm, NoAFO
  • Experimental: Arm 15:
    Testing Order: Clinical AFO, Short Soft, Tall Firm, Short Firm, Tall Soft, NoAFO
  • Experimental: Arm 16:
    Testing Order: Clinical AFO, Short Soft, Tall Firm, Tall Soft, Short Firm, NoAFO
  • Experimental: Arm 17:
    Testing Order: Clinical AFO, Short Soft, Short Firm, Tall Soft, Tall Firm, NoAFO
  • Experimental: Arm 18:
    Testing Order: Clinical AFO, Short Soft, Short Firm, Tall Firm, Tall Soft, NoAFO
  • Experimental: Arm 19:
    Testing Order: Clinical AFO, Short Firm, Tall Soft, Tall Firm, Short Soft, NoAFO
  • Experimental: Arm 20:
    Testing Order: Clinical AFO, Short Firm, Tall Soft, Short Soft, Tall Firm, NoAFO
  • Experimental: Arm 21:
    Testing Order: Clinical AFO, Short Firm, Tall Firm, Short Soft, Tall Soft, NoAFO
  • Experimental: Arm 22:
    Testing Order: Clinical AFO, Short Firm, Tall Firm, Tall Soft, Short Soft, NoAFO
  • Experimental: Arm 23:
    Testing Order: Clinical AFO, Short Firm, Short Soft, Tall Firm, Tall Soft, NoAFO
  • Experimental: Arm 24:
    Testing Order: Clinical AFO, Short Firm, Short Soft, Tall Soft, Tall Firm, NoAFO

Primary Outcome Measure

Center of pressure velocity timing [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242
Jason M Wilken, PT, PhD
[email protected]
319-335-6857
Kirsten M Anderson, PhD
[email protected]
319-353-0431
Jason M Wilken, PT, PhD (PRINCIPAL_INVESTIGATOR)
Molly Pacha, MS, ATC, LAT (SUB_INVESTIGATOR)

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