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The Effects of AFO Heel Height and Stiffness on Gait

ConditionsMusculoskeletal InjuryMusculoskeletal DiseasesPeripheral Nervous System Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Iowa

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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

Treatment groups

40 Participants
are divided into 24 treatment groups

24

Treatment groups

See each treatment group below.

Group A: Arm 1:Experimental treatment 4 interventions
Group B: Arm 2:Experimental treatment 4 interventions
Group C: Arm 3:Experimental treatment 4 interventions
Group D: Arm 4:Experimental treatment 4 interventions
Group E: Arm 5:Experimental treatment 4 interventions
Group F: Arm 6:Experimental treatment 4 interventions
Group G: Arm 7:Experimental treatment 4 interventions
Group H: Arm 8:Experimental treatment 4 interventions
Group I: Arm 9:Experimental treatment 4 interventions
Group J: Arm 10:Experimental treatment 4 interventions
Group K: Arm 11:Experimental treatment 4 interventions
Group L: Arm 12:Experimental treatment 4 interventions
Group M: Arm 13:Experimental treatment 4 interventions
Group N: Arm 14:Experimental treatment 4 interventions
Group O: Arm 15:Experimental treatment 4 interventions
Group P: Arm 16:Experimental treatment 4 interventions
Group Q: Arm 17:Experimental treatment 4 interventions
Group R: Arm 18:Experimental treatment 4 interventions
Group S: Arm 19:Experimental treatment 4 interventions
Group T: Arm 20:Experimental treatment 4 interventions
Group U: Arm 21:Experimental treatment 4 interventions
Group V: Arm 22:Experimental treatment 4 interventions
Group W: Arm 23:Experimental treatment 4 interventions
Group X: Arm 24:Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Center of pressure velocity timing

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

Time frame
Baseline
2

Center of pressure velocity magnitude

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

Time frame
Baseline
3

Modified Socket Comfort Score (Comfort)

Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.

Time frame
Baseline
4

Modified Socket Comfort Score (Smoothness)

Smoothness scores range from 0 = least smooth to 10 = most smooth.

Time frame
Baseline

Secondary outcomes

1

Ankle Range of Motion

Ankle range of motion (degrees) during gait.

Time frame
Baseline
2

Peak Ankle Moment

Peak ankle moment (Nm/kg) during gait.

Time frame
Baseline
3

Peak Ankle Power

Peak ankle power (W/kg) during gait.

Time frame
Baseline

Other outcomes

1

Activities-Specific Balance Confidence (ABC)

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

Time frame
Baseline
2

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.

Time frame
Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Iowa

Lead sponsor

Source ClinicalTrials.gov
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