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The Effects of AFO Heel Height and Stiffness on Gait (AFOHeel)

Primary Purpose

Musculoskeletal Injury, Musculoskeletal Diseases, Peripheral Nervous System Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tall Soft
Tall Firm
Short Soft
Short Firm
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Musculoskeletal Injury focused on measuring Gait Analysis, Ankle Foot Orthosis, Biomechanics

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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of pregnant individuals, and resulting inability to account for its effect on resulting outcomes participants will be withdrawn from the study.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.

Sites / Locations

  • University of IowaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm 21

Arm 22

Arm 23

Arm 24

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1:

Arm 2:

Arm 3:

Arm 4:

Arm 5:

Arm 6:

Arm 7:

Arm 8:

Arm 9:

Arm 10:

Arm 11:

Arm 12:

Arm 13:

Arm 14:

Arm 15:

Arm 16:

Arm 17:

Arm 18:

Arm 19:

Arm 20:

Arm 21:

Arm 22:

Arm 23:

Arm 24:

Arm Description

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Ankle Range of Motion
Ankle range of motion (degrees) during gait.
Peak Ankle Moment
Peak ankle moment (Nm/kg) during gait.
Peak Ankle Power
Peak ankle power (W/kg) during gait.
Center of pressure velocity timing
Timing of peak center of pressure velocity (percent stance) during gait.
Center of pressure velocity magnitude
Magnitude of peak center of pressure velocity (m/s) during gait.
Modified Socket Comfort Score (Comfort and Smoothness)
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable, and from 0 = least smooth to 10 = most smooth.

Secondary Outcome Measures

Activities-Specific Balance Confidence (ABC)
The ABC provides a standardized evaluation of balance confidence across a range of common daily tasks.
PROMIS Patient reported outcomes for physical function
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.
Participant wedge preference
The participant will rank order their preference for their Clinical AFO, Tall Soft, Tall Firm, Short Soft, or Short Firm wedge on a questionnaire.
Numerical Pain Rating Scale
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.

Full Information

First Posted
March 11, 2021
Last Updated
February 20, 2023
Sponsor
University of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT04800484
Brief Title
The Effects of AFO Heel Height and Stiffness on Gait
Acronym
AFOHeel
Official Title
The Effects of AFO Heel Height and Stiffness on Gait
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Injury, Musculoskeletal Diseases, Peripheral Nervous System Diseases
Keywords
Gait Analysis, Ankle Foot Orthosis, Biomechanics

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Participant
Masking Description
Participants will be blinded to the heel wedge conditions.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1:
Arm Type
Experimental
Arm Description
Testing Order: Clinical AFO, Tall Soft, Tall Firm, Short Soft, Short Firm, NoAFO
Arm Title
Arm 2:
Arm Type
Experimental
Arm Description
Testing Order: Clinical AFO, Tall Soft, Tall Firm, Short Firm, Short Soft, NoAFO
Arm Title
Arm 3:
Arm Type
Experimental
Arm Description
Testing Order: Clinical AFO, Tall Soft, Short Soft, Tall Firm, Short Firm, NoAFO
Arm Title
Arm 4:
Arm Type
Experimental
Arm Description
Testing Order: Clinical AFO, Tall Soft, Short Soft, Short Firm, Tall Firm, NoAFO
Arm Title
Arm 5:
Arm Type
Experimental
Arm Description
Testing Order: Clinical AFO, Tall Soft, Short Firm, Tall Firm, Short Soft, NoAFO
Arm Title
Arm 6:
Arm Type
Experimental
Arm Description
Testing Order: Clinical AFO, Tall Soft, Short Firm, Short Soft, Tall Firm, NoAFO
Arm Title
Arm 7:
Arm Type
Experimental
Arm Description
Testing Order: Clinical AFO, Tall Firm, Tall Soft, Short Soft, Short Firm, NoAFO
Arm Title
Arm 8:
Arm Type
Experimental
Arm Description
Testing Order: Clinical AFO, Tall Firm, Tall Soft, Short Firm, Short Soft, NoAFO
Arm Title
Arm 9:
Arm Type
Experimental
Arm Description
Testing Order: Clinical AFO, Tall Firm, Short Soft, Tall Soft, Short Firm, NoAFO
Arm Title
Arm 10:
Arm Type
Experimental
Arm Description
Testing Order: Clinical AFO, Tall Firm, Short Soft, Short Firm, Tall Soft, NoAFO
Arm Title
Arm 11:
Arm Type
Experimental
Arm Description
Testing Order: Clinical AFO, Tall Firm, Short Firm, Tall Soft, Short Soft, NoAFO
Arm Title
Arm 12:
Arm Type
Experimental
Arm Description
Testing Order: Clinical AFO, Tall Firm, Short Firm, Short Soft, Tall Soft, NoAFO
Arm Title
Arm 13:
Arm Type
Experimental
Arm Description
Testing Order: Clinical AFO, Short Soft, Tall Soft, Short Firm, Tall Firm, NoAFO
Arm Title
Arm 14:
Arm Type
Experimental
Arm Description
Testing Order: Clinical AFO, Short Soft, Tall Soft, Tall Firm, Short Firm, NoAFO
Arm Title
Arm 15:
Arm Type
Experimental
Arm Description
Testing Order: Clinical AFO, Short Soft, Tall Firm, Short Firm, Tall Soft, NoAFO
Arm Title
Arm 16:
Arm Type
Experimental
Arm Description
Testing Order: Clinical AFO, Short Soft, Tall Firm, Tall Soft, Short Firm, NoAFO
Arm Title
Arm 17:
Arm Type
Experimental
Arm Description
Testing Order: Clinical AFO, Short Soft, Short Firm, Tall Soft, Tall Firm, NoAFO
Arm Title
Arm 18:
Arm Type
Experimental
Arm Description
Testing Order: Clinical AFO, Short Soft, Short Firm, Tall Firm, Tall Soft, NoAFO
Arm Title
Arm 19:
Arm Type
Experimental
Arm Description
Testing Order: Clinical AFO, Short Firm, Tall Soft, Tall Firm, Short Soft, NoAFO
Arm Title
Arm 20:
Arm Type
Experimental
Arm Description
Testing Order: Clinical AFO, Short Firm, Tall Soft, Short Soft, Tall Firm, NoAFO
Arm Title
Arm 21:
Arm Type
Experimental
Arm Description
Testing Order: Clinical AFO, Short Firm, Tall Firm, Short Soft, Tall Soft, NoAFO
Arm Title
Arm 22:
Arm Type
Experimental
Arm Description
Testing Order: Clinical AFO, Short Firm, Tall Firm, Tall Soft, Short Soft, NoAFO
Arm Title
Arm 23:
Arm Type
Experimental
Arm Description
Testing Order: Clinical AFO, Short Firm, Short Soft, Tall Firm, Tall Soft, NoAFO
Arm Title
Arm 24:
Arm Type
Experimental
Arm Description
Testing Order: Clinical AFO, Short Firm, Short Soft, Tall Soft, Tall Firm, NoAFO
Intervention Type
Device
Intervention Name(s)
Tall Soft
Other Intervention Name(s)
TS
Intervention Description
Tall heel wedge made of soft foam
Intervention Type
Device
Intervention Name(s)
Tall Firm
Other Intervention Name(s)
TF
Intervention Description
Tall heel wedge made of firm foam
Intervention Type
Device
Intervention Name(s)
Short Soft
Other Intervention Name(s)
SS
Intervention Description
Short heel wedge made of soft foam
Intervention Type
Device
Intervention Name(s)
Short Firm
Other Intervention Name(s)
SF
Intervention Description
Short heel wedge made of firm foam
Primary Outcome Measure Information:
Title
Ankle Range of Motion
Description
Ankle range of motion (degrees) during gait.
Time Frame
Baseline
Title
Peak Ankle Moment
Description
Peak ankle moment (Nm/kg) during gait.
Time Frame
Baseline
Title
Peak Ankle Power
Description
Peak ankle power (W/kg) during gait.
Time Frame
Baseline
Title
Center of pressure velocity timing
Description
Timing of peak center of pressure velocity (percent stance) during gait.
Time Frame
Baseline
Title
Center of pressure velocity magnitude
Description
Magnitude of peak center of pressure velocity (m/s) during gait.
Time Frame
Baseline
Title
Modified Socket Comfort Score (Comfort and Smoothness)
Description
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable, and from 0 = least smooth to 10 = most smooth.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Activities-Specific Balance Confidence (ABC)
Description
The ABC provides a standardized evaluation of balance confidence across a range of common daily tasks.
Time Frame
Baseline
Title
PROMIS Patient reported outcomes for physical function
Description
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.
Time Frame
Baseline
Title
Participant wedge preference
Description
The participant will rank order their preference for their Clinical AFO, Tall Soft, Tall Firm, Short Soft, or Short Firm wedge on a questionnaire.
Time Frame
Baseline
Title
Numerical Pain Rating Scale
Description
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason M Wilken, PT, PhD
Phone
319-335-6857
Email
jason-wilken@uiowa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kirsten M Anderson, BSE
Phone
319-353-0431
Email
kirsten-m-anderson@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason M Wilken, PT, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason M Wilken, PT, PhD
Phone
319-335-6857
Email
Jason-wilken@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Kirsten M Anderson, BSE
Phone
319-353-0431
Email
kirsten-m-anderson@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Jason M Wilken, PT, PhD
First Name & Middle Initial & Last Name & Degree
Molly Pacha, MS, ATC, LAT

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effects of AFO Heel Height and Stiffness on Gait

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