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AFOHeel: The Effects of AFO Heel Height and Stiffness on Gait

Sponsor
University of Iowa (Other)
Overall Status
Recruiting
CT.gov ID
NCT04800484
Collaborator
(none)
40
Enrollment
1
Location
24
Arms
38.8
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Tall Soft
  • Device: Tall Firm
  • Device: Short Soft
  • Device: Short Firm
 N/A

Detailed Description

In this study the investigators to evaluate 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.

Two groups of subjects with impairments below the knee, that result in functional deficits and require daily AFO use, will be recruited for this study. The first group will have unilateral deficits associated with musculoskeletal injury or disease (Group 1), and the second group will have bilateral or unilateral deficits associated with peripheral nervous system disease (Group 2).

Lower limb forces and body motion will be assessed using computerized motion capture and force plates in the floor, as individuals walk over-ground. Small reflective markers placed on the participant's skin and force measuring plates in the floor will be used. Participants will walk with their clinically provided AFO, with added heel cushions of two different heights and stiffness's (4 conditions) at a controlled velocity and self-selected velocity. If able, they will walk without their AFO at a self-selected pace. Participants will be asked to provide information regarding their health condition and opinions of the conditions tested.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Participants will be evaluated in their clinically configured AFO and without an AFO if able. They will also complete evaluation with four provided heel wedge conditions in randomized order: tall soft, tall firm, short soft, short firm.Participants will be evaluated in their clinically configured AFO and without an AFO if able. They will also complete evaluation with four provided heel wedge conditions in randomized order: tall soft, tall firm, short soft, short firm.
Masking:
Single (Participant)
Masking Description:
Participants will be blinded to the heel wedge conditions.
Primary Purpose:
Basic Science
Official Title:
The Effects of AFO Heel Height and Stiffness on Gait
Actual Study Start Date :
Nov 7, 2019
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1:

Testing Order: Clinical AFO, Tall Soft, Tall Firm, Short Soft, Short Firm, NoAFO

Device: Tall Soft
Tall heel wedge made of soft foam
Other Names:
  • TS

    • Device: Tall Firm
    Tall heel wedge made of firm foam
    Other Names:
  • TF

    • Device: Short Soft
    Short heel wedge made of soft foam
    Other Names:
  • SS

    • Device: Short Firm
    Short heel wedge made of firm foam
    Other Names:
  • SF

    		•
    Experimental: Arm 2:

    Testing Order: Clinical AFO, Tall Soft, Tall Firm, Short Firm, Short Soft, NoAFO

    Device: Tall Soft
    Tall heel wedge made of soft foam
    Other Names:
  • TS

    • Device: Tall Firm
    Tall heel wedge made of firm foam
    Other Names:
  • TF

    • Device: Short Soft
    Short heel wedge made of soft foam
    Other Names:
  • SS

    • Device: Short Firm
    Short heel wedge made of firm foam
    Other Names:
  • SF

    		•
    Experimental: Arm 3:

    Testing Order: Clinical AFO, Tall Soft, Short Soft, Tall Firm, Short Firm, NoAFO

    Device: Tall Soft
    Tall heel wedge made of soft foam
    Other Names:
  • TS

    • Device: Tall Firm
    Tall heel wedge made of firm foam
    Other Names:
  • TF

    • Device: Short Soft
    Short heel wedge made of soft foam
    Other Names:
  • SS

    • Device: Short Firm
    Short heel wedge made of firm foam
    Other Names:
  • SF

    		•
    Experimental: Arm 4:

    Testing Order: Clinical AFO, Tall Soft, Short Soft, Short Firm, Tall Firm, NoAFO

    Device: Tall Soft
    Tall heel wedge made of soft foam
    Other Names:
  • TS

    • Device: Tall Firm
    Tall heel wedge made of firm foam
    Other Names:
  • TF

    • Device: Short Soft
    Short heel wedge made of soft foam
    Other Names:
  • SS

    • Device: Short Firm
    Short heel wedge made of firm foam
    Other Names:
  • SF

    		•
    Experimental: Arm 5:

    Testing Order: Clinical AFO, Tall Soft, Short Firm, Tall Firm, Short Soft, NoAFO

    Device: Tall Soft
    Tall heel wedge made of soft foam
    Other Names:
  • TS

    • Device: Tall Firm
    Tall heel wedge made of firm foam
    Other Names:
  • TF

    • Device: Short Soft
    Short heel wedge made of soft foam
    Other Names:
  • SS

    • Device: Short Firm
    Short heel wedge made of firm foam
    Other Names:
  • SF

    		•
    Experimental: Arm 6:

    Testing Order: Clinical AFO, Tall Soft, Short Firm, Short Soft, Tall Firm, NoAFO

    Device: Tall Soft
    Tall heel wedge made of soft foam
    Other Names:
  • TS

    • Device: Tall Firm
    Tall heel wedge made of firm foam
    Other Names:
  • TF

    • Device: Short Soft
    Short heel wedge made of soft foam
    Other Names:
  • SS

    • Device: Short Firm
    Short heel wedge made of firm foam
    Other Names:
  • SF

    		•
    Experimental: Arm 7:

    Testing Order: Clinical AFO, Tall Firm, Tall Soft, Short Soft, Short Firm, NoAFO

    Device: Tall Soft
    Tall heel wedge made of soft foam
    Other Names:
  • TS

    • Device: Tall Firm
    Tall heel wedge made of firm foam
    Other Names:
  • TF

    • Device: Short Soft
    Short heel wedge made of soft foam
    Other Names:
  • SS

    • Device: Short Firm
    Short heel wedge made of firm foam
    Other Names:
  • SF

    		•
    Experimental: Arm 8:

    Testing Order: Clinical AFO, Tall Firm, Tall Soft, Short Firm, Short Soft, NoAFO

    Device: Tall Soft
    Tall heel wedge made of soft foam
    Other Names:
  • TS

    • Device: Tall Firm
    Tall heel wedge made of firm foam
    Other Names:
  • TF

    • Device: Short Soft
    Short heel wedge made of soft foam
    Other Names:
  • SS

    • Device: Short Firm
    Short heel wedge made of firm foam
    Other Names:
  • SF

    		•
    Experimental: Arm 9:

    Testing Order: Clinical AFO, Tall Firm, Short Soft, Tall Soft, Short Firm, NoAFO

    Device: Tall Soft
    Tall heel wedge made of soft foam
    Other Names:
  • TS

    • Device: Tall Firm
    Tall heel wedge made of firm foam
    Other Names:
  • TF

    • Device: Short Soft
    Short heel wedge made of soft foam
    Other Names:
  • SS

    • Device: Short Firm
    Short heel wedge made of firm foam
    Other Names:
  • SF

    		•
    Experimental: Arm 10:

    Testing Order: Clinical AFO, Tall Firm, Short Soft, Short Firm, Tall Soft, NoAFO

    Device: Tall Soft
    Tall heel wedge made of soft foam
    Other Names:
  • TS

    • Device: Tall Firm
    Tall heel wedge made of firm foam
    Other Names:
  • TF

    • Device: Short Soft
    Short heel wedge made of soft foam
    Other Names:
  • SS

    • Device: Short Firm
    Short heel wedge made of firm foam
    Other Names:
  • SF

    		•
    Experimental: Arm 11:

    Testing Order: Clinical AFO, Tall Firm, Short Firm, Tall Soft, Short Soft, NoAFO

    Device: Tall Soft
    Tall heel wedge made of soft foam
    Other Names:
  • TS

    • Device: Tall Firm
    Tall heel wedge made of firm foam
    Other Names:
  • TF

    • Device: Short Soft
    Short heel wedge made of soft foam
    Other Names:
  • SS

    • Device: Short Firm
    Short heel wedge made of firm foam
    Other Names:
  • SF

    		•
    Experimental: Arm 12:

    Testing Order: Clinical AFO, Tall Firm, Short Firm, Short Soft, Tall Soft, NoAFO

    Device: Tall Soft
    Tall heel wedge made of soft foam
    Other Names:
  • TS

    • Device: Tall Firm
    Tall heel wedge made of firm foam
    Other Names:
  • TF

    • Device: Short Soft
    Short heel wedge made of soft foam
    Other Names:
  • SS

    • Device: Short Firm
    Short heel wedge made of firm foam
    Other Names:
  • SF

    		•
    Experimental: Arm 13:

    Testing Order: Clinical AFO, Short Soft, Tall Soft, Short Firm, Tall Firm, NoAFO

    Device: Tall Soft
    Tall heel wedge made of soft foam
    Other Names:
  • TS

    • Device: Tall Firm
    Tall heel wedge made of firm foam
    Other Names:
  • TF

    • Device: Short Soft
    Short heel wedge made of soft foam
    Other Names:
  • SS

    • Device: Short Firm
    Short heel wedge made of firm foam
    Other Names:
  • SF

    		•
    Experimental: Arm 14:

    Testing Order: Clinical AFO, Short Soft, Tall Soft, Tall Firm, Short Firm, NoAFO

    Device: Tall Soft
    Tall heel wedge made of soft foam
    Other Names:
  • TS

    • Device: Tall Firm
    Tall heel wedge made of firm foam
    Other Names:
  • TF

    • Device: Short Soft
    Short heel wedge made of soft foam
    Other Names:
  • SS

    • Device: Short Firm
    Short heel wedge made of firm foam
    Other Names:
  • SF

    		•
    Experimental: Arm 15:

    Testing Order: Clinical AFO, Short Soft, Tall Firm, Short Firm, Tall Soft, NoAFO

    Device: Tall Soft
    Tall heel wedge made of soft foam
    Other Names:
  • TS

    • Device: Tall Firm
    Tall heel wedge made of firm foam
    Other Names:
  • TF

    • Device: Short Soft
    Short heel wedge made of soft foam
    Other Names:
  • SS

    • Device: Short Firm
    Short heel wedge made of firm foam
    Other Names:
  • SF

    		•
    Experimental: Arm 16:

    Testing Order: Clinical AFO, Short Soft, Tall Firm, Tall Soft, Short Firm, NoAFO

    Device: Tall Soft
    Tall heel wedge made of soft foam
    Other Names:
  • TS

    • Device: Tall Firm
    Tall heel wedge made of firm foam
    Other Names:
  • TF

    • Device: Short Soft
    Short heel wedge made of soft foam
    Other Names:
  • SS

    • Device: Short Firm
    Short heel wedge made of firm foam
    Other Names:
  • SF

    		•
    Experimental: Arm 17:

    Testing Order: Clinical AFO, Short Soft, Short Firm, Tall Soft, Tall Firm, NoAFO

    Device: Tall Soft
    Tall heel wedge made of soft foam
    Other Names:
  • TS

    • Device: Tall Firm
    Tall heel wedge made of firm foam
    Other Names:
  • TF

    • Device: Short Soft
    Short heel wedge made of soft foam
    Other Names:
  • SS

    • Device: Short Firm
    Short heel wedge made of firm foam
    Other Names:
  • SF

    		•
    Experimental: Arm 18:

    Testing Order: Clinical AFO, Short Soft, Short Firm, Tall Firm, Tall Soft, NoAFO

    Device: Tall Soft
    Tall heel wedge made of soft foam
    Other Names:
  • TS

    • Device: Tall Firm
    Tall heel wedge made of firm foam
    Other Names:
  • TF

    • Device: Short Soft
    Short heel wedge made of soft foam
    Other Names:
  • SS

    • Device: Short Firm
    Short heel wedge made of firm foam
    Other Names:
  • SF

    		•
    Experimental: Arm 19:

    Testing Order: Clinical AFO, Short Firm, Tall Soft, Tall Firm, Short Soft, NoAFO

    Device: Tall Soft
    Tall heel wedge made of soft foam
    Other Names:
  • TS

    • Device: Tall Firm
    Tall heel wedge made of firm foam
    Other Names:
  • TF

    • Device: Short Soft
    Short heel wedge made of soft foam
    Other Names:
  • SS

    • Device: Short Firm
    Short heel wedge made of firm foam
    Other Names:
  • SF

    		•
    Experimental: Arm 20:

    Testing Order: Clinical AFO, Short Firm, Tall Soft, Short Soft, Tall Firm, NoAFO

    Device: Tall Soft
    Tall heel wedge made of soft foam
    Other Names:
  • TS

    • Device: Tall Firm
    Tall heel wedge made of firm foam
    Other Names:
  • TF

    • Device: Short Soft
    Short heel wedge made of soft foam
    Other Names:
  • SS

    • Device: Short Firm
    Short heel wedge made of firm foam
    Other Names:
  • SF

    		•
    Experimental: Arm 21:

    Testing Order: Clinical AFO, Short Firm, Tall Firm, Short Soft, Tall Soft, NoAFO

    Device: Tall Soft
    Tall heel wedge made of soft foam
    Other Names:
  • TS

    • Device: Tall Firm
    Tall heel wedge made of firm foam
    Other Names:
  • TF

    • Device: Short Soft
    Short heel wedge made of soft foam
    Other Names:
  • SS

    • Device: Short Firm
    Short heel wedge made of firm foam
    Other Names:
  • SF

    		•
    Experimental: Arm 22:

    Testing Order: Clinical AFO, Short Firm, Tall Firm, Tall Soft, Short Soft, NoAFO

    Device: Tall Soft
    Tall heel wedge made of soft foam
    Other Names:
  • TS

    • Device: Tall Firm
    Tall heel wedge made of firm foam
    Other Names:
  • TF

    • Device: Short Soft
    Short heel wedge made of soft foam
    Other Names:
  • SS

    • Device: Short Firm
    Short heel wedge made of firm foam
    Other Names:
  • SF

    		•
    Experimental: Arm 23:

    Testing Order: Clinical AFO, Short Firm, Short Soft, Tall Firm, Tall Soft, NoAFO

    Device: Tall Soft
    Tall heel wedge made of soft foam
    Other Names:
  • TS

    • Device: Tall Firm
    Tall heel wedge made of firm foam
    Other Names:
  • TF

    • Device: Short Soft
    Short heel wedge made of soft foam
    Other Names:
  • SS

    • Device: Short Firm
    Short heel wedge made of firm foam
    Other Names:
  • SF

    		•
    Experimental: Arm 24:

    Testing Order: Clinical AFO, Short Firm, Short Soft, Tall Soft, Tall Firm, NoAFO

    Device: Tall Soft
    Tall heel wedge made of soft foam
    Other Names:
  • TS

    • Device: Tall Firm
    Tall heel wedge made of firm foam
    Other Names:
  • TF

    • Device: Short Soft
    Short heel wedge made of soft foam
    Other Names:
  • SS

    • Device: Short Firm
    Short heel wedge made of firm foam
    Other Names:
  • SF

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ankle Range of Motion [Baseline]

      Ankle range of motion (degrees) during gait.

    2. Peak Ankle Moment [Baseline]

      Peak ankle moment (Nm/kg) during gait.

    3. Peak Ankle Power [Baseline]

      Peak ankle power (W/kg) during gait.

    4. Center of pressure velocity timing [Baseline]

      Timing of peak center of pressure velocity (percent stance) during gait.

    5. Center of pressure velocity magnitude [Baseline]

      Magnitude of peak center of pressure velocity (m/s) during gait.

    6. Modified Socket Comfort Score (Comfort and Smoothness) [Baseline]

      Comfort scores range from 0 = most uncomfortable to 10 = most comfortable, and from 0 = least smooth to 10 = most smooth.

    Secondary Outcome Measures

    1. Activities-Specific Balance Confidence (ABC) [Baseline]

      The ABC provides a standardized evaluation of balance confidence across a range of common daily tasks.

    2. PROMIS Patient reported outcomes for physical function [Baseline]

      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.

    3. Participant wedge preference [Baseline]

      The participant will rank order their preference for their Clinical AFO, Tall Soft, Tall Firm, Short Soft, or Short Firm wedge on a questionnaire.

    4. Numerical Pain Rating Scale [Baseline]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    GROUP 1 Patient Inclusion criteria

    • Ages: 18-70

    • Daily AFO use to address unilateral, below knee functional deficits that result from limb injury or musculoskeletal disease (e.g. fracture, muscle and/or nerve injury, ankle arthritis)

    • Greater than 2 weeks using their current AFO

    • Ability to walk 50 feet without use of an assistive device (Cane, crutch, etc.)

    • Ability to walk at a slow to moderate pace

    • AFO fits into traditional footwear

    • Able to read and write in English and provide written informed consent

    GROUP 1 Patient Exclusion criteria

    • Pain > 6/10 while walking during testing or an increase in pain during testing of > 2/10.

    • Central Nervous System disorder or disease (e.g. Stroke, Cerebral Palsy, Spinal Cord Injury, or other conditions that result in lower limb spasticity).

    • Disorder or disease that affects peripheral nerve function (e.g. diabetes, Charcot Marie Tooth).

    • Limited contralateral lower limb function due to injury or neurological/musculoskeletal disorder.

    • Use of a hinged/articulating AFO (e.g. Plantar flexion stop, Dorsiflexion assist/stop, free motion), Charcot Restraint Orthotic Walker (CROW) boot, AFOs that restrict all motion in the ankle and foot.

    • Use of an AFO that crosses the knee (Knee brace)

    • Insufficient space in shoe to accommodate the tallest heel wedge and their AFO

    • Visual or hearing impairments that limit walking ability or could limit the ability to comply with instructions given during testing

    • Pregnancy - Per participant self-report. Due the expected small number of pregnant individuals, and resulting inability to account for its effect on resulting outcomes participants will be withdrawn from the study.

    • Body Mass index > 40.

    GROUP 2 Patient Inclusion Criteria

    • Ages: 18-70

    • Daily AFO use to address below knee functional deficits that result from disease involving the peripheral nervous system (e.g. Charcot Marie Tooth, Multiple Sclerosis, diabetes)

    • Greater than 2 weeks using their current AFO (unilateral or bilateral)

    • Ability to walk 50 feet without use of an assistive device (Cane, crutch, etc.)

    • AFO fits into traditional footwear

    • Ability to walk at a slow to moderate pace

    • Able to read and write in English and provide written informed consent

    GROUP 2 Patient Exclusion Criteria

    • Pain > 6/10 while walking or an increase in pain during testing of > 2/10

    • Central Nervous System disorder or disease (e.g. Stroke, Cerebral Palsy, Spinal Cord Injury, or other conditions that result in lower limb spasticity)

    • Limited function due to limb injury (e.g. fracture, muscle and/or nerve injury)

    • Use of a hinged/articulating AFO (e.g. Plantar flexion stop, Dorsiflexion assist/stop, free motion), Charcot Restraint Orthotic Walker (CROW) boot, AFOs that restrict all motion in the ankle and foot.

    • Use of an AFO that crosses the knee (Knee brace)

    • Insufficient space in shoe to accommodate the tallest heel wedge and their AFO

    • Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing

    • Pregnancy - Per participant self-report. Due the expected small number of pregnant individuals, and resulting inability to account for its effect on resulting outcomes participants will be withdrawn from the study

    • Body Mass index > 40.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Iowa Iowa City Iowa United States 52242

    Sponsors and Collaborators

    • University of Iowa

    Investigators

    • Principal Investigator: Jason M Wilken, PT, PhD, University of Iowa

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jason Wilken, Associate Professor, University of Iowa
    ClinicalTrials.gov Identifier:
    NCT04800484
    Other Study ID Numbers:
    • 201811701
    First Posted:
    Mar 16, 2021
    Last Update Posted:
    Jan 13, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Jason Wilken, Associate Professor, University of Iowa
    Gait Analysis
    Ankle Foot Orthosis
    Biomechanics
    Additional relevant MeSH terms:
    Musculoskeletal Diseases
    Nervous System Diseases
    Peripheral Nervous System Diseases

    Study Results

    No Results Posted as of Jan 13, 2022