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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: | Experimental | Testing Order: Clinical AFO, Tall Soft, Tall Firm, Short Soft, Short Firm, NoAFO |
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| Arm 2: | Experimental | Testing Order: Clinical AFO, Tall Soft, Tall Firm, Short Firm, Short Soft, NoAFO |
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| Arm 3: | Experimental | Testing Order: Clinical AFO, Tall Soft, Short Soft, Tall Firm, Short Firm, NoAFO |
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| Arm 4: | Experimental | Testing Order: Clinical AFO, Tall Soft, Short Soft, Short Firm, Tall Firm, NoAFO |
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| Arm 5: | Experimental | Testing Order: Clinical AFO, Tall Soft, Short Firm, Tall Firm, Short Soft, NoAFO |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tall Soft | Device | Tall heel wedge made of soft foam |
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| Measure | Description | Time Frame |
|---|---|---|
| Center of pressure velocity timing | Timing of peak center of pressure velocity (percent stance) during gait. | Baseline |
| Center of pressure velocity magnitude | Magnitude of peak center of pressure velocity (m/s) during gait. | Baseline |
| Modified Socket Comfort Score (Comfort) | Comfort scores range from 0 = most uncomfortable to 10 = most comfortable. | Baseline |
| Modified Socket Comfort Score (Smoothness) | Smoothness scores range from 0 = least smooth to 10 = most smooth. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Ankle Range of Motion | Ankle range of motion (degrees) during gait. | Baseline |
| Peak Ankle Moment | Peak ankle moment (Nm/kg) during gait. |
| Measure | Description | Time Frame |
|---|---|---|
| Activities-Specific Balance Confidence (ABC) | The ABC provides a standardized evaluation of balance confidence across a range of common daily tasks. | Baseline |
| PROMIS Patient reported outcomes for physical function |
GROUP 1 Patient Inclusion criteria
GROUP 1 Patient Exclusion criteria
GROUP 2 Patient Inclusion Criteria
GROUP 2 Patient Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jason M Wilken, PT, PhD | Contact | 319-335-6857 | jason-wilken@uiowa.edu | |
| Kirsten M Anderson, PhD | Contact | 319-353-0431 | kirsten-m-anderson@uiowa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jason M Wilken, PT, PhD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
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| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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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.
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Participants will be blinded to the heel wedge conditions.
| Arm 6: | Experimental | Testing Order: Clinical AFO, Tall Soft, Short Firm, Short Soft, Tall Firm, NoAFO |
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| Arm 7: | Experimental | Testing Order: Clinical AFO, Tall Firm, Tall Soft, Short Soft, Short Firm, NoAFO |
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| Arm 8: | Experimental | Testing Order: Clinical AFO, Tall Firm, Tall Soft, Short Firm, Short Soft, NoAFO |
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| Arm 9: | Experimental | Testing Order: Clinical AFO, Tall Firm, Short Soft, Tall Soft, Short Firm, NoAFO |
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| Arm 10: | Experimental | Testing Order: Clinical AFO, Tall Firm, Short Soft, Short Firm, Tall Soft, NoAFO |
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| Arm 11: | Experimental | Testing Order: Clinical AFO, Tall Firm, Short Firm, Tall Soft, Short Soft, NoAFO |
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| Arm 12: | Experimental | Testing Order: Clinical AFO, Tall Firm, Short Firm, Short Soft, Tall Soft, NoAFO |
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| Arm 13: | Experimental | Testing Order: Clinical AFO, Short Soft, Tall Soft, Short Firm, Tall Firm, NoAFO |
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| Arm 14: | Experimental | Testing Order: Clinical AFO, Short Soft, Tall Soft, Tall Firm, Short Firm, NoAFO |
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| Arm 15: | Experimental | Testing Order: Clinical AFO, Short Soft, Tall Firm, Short Firm, Tall Soft, NoAFO |
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| Arm 16: | Experimental | Testing Order: Clinical AFO, Short Soft, Tall Firm, Tall Soft, Short Firm, NoAFO |
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| Arm 17: | Experimental | Testing Order: Clinical AFO, Short Soft, Short Firm, Tall Soft, Tall Firm, NoAFO |
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| Arm 18: | Experimental | Testing Order: Clinical AFO, Short Soft, Short Firm, Tall Firm, Tall Soft, NoAFO |
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| Arm 19: | Experimental | Testing Order: Clinical AFO, Short Firm, Tall Soft, Tall Firm, Short Soft, NoAFO |
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| Arm 20: | Experimental | Testing Order: Clinical AFO, Short Firm, Tall Soft, Short Soft, Tall Firm, NoAFO |
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| Arm 21: | Experimental | Testing Order: Clinical AFO, Short Firm, Tall Firm, Short Soft, Tall Soft, NoAFO |
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| Arm 22: | Experimental | Testing Order: Clinical AFO, Short Firm, Tall Firm, Tall Soft, Short Soft, NoAFO |
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| Arm 23: | Experimental | Testing Order: Clinical AFO, Short Firm, Short Soft, Tall Firm, Tall Soft, NoAFO |
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| Arm 24: | Experimental | Testing Order: Clinical AFO, Short Firm, Short Soft, Tall Soft, Tall Firm, NoAFO |
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| Tall Firm | Device | Tall heel wedge made of firm foam |
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| Short Soft | Device | Short heel wedge made of soft foam |
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| Short Firm | Device | Short heel wedge made of firm foam |
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| Baseline |
| Peak Ankle Power | Peak ankle power (W/kg) during gait. | 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.
| Baseline |