AFO Adjustments for Musculoskeletal Disorders

(AFOHeel Trial)

Overseen By Kirsten M Anderson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Iowa

Disqualifiers: CNS disorders, Peripheral nerve disorders, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of ankle foot orthosis (AFO) heel cushions affect walking for individuals with conditions like ankle arthritis or nerve injury. Participants will test various combinations of heel heights and stiffness levels to determine which setup best supports everyday walking. The aim is to identify the most effective AFO adjustments to improve movement. This trial suits those who use an AFO daily, have been using it for over two weeks, and can walk 50 feet without additional support like a cane or crutch. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance daily mobility for AFO users.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on the use of ankle foot orthosis (AFO) and walking ability.

What prior data suggests that these AFO adjustments are safe for musculoskeletal disorders?

Research shows that ankle foot orthoses (AFOs) are generally safe and well-tolerated by users. Studies have found that AFOs can help improve balance and movement. Specifically, research on different types of AFOs, such as Short Firm, Short Soft, Tall Firm, and Tall Soft, has not identified any major safety concerns.

For instance, AFOs like the Short Firm and Short Soft types can correct foot and ankle issues and reduce pain, indicating effectiveness for many people. The Tall Firm and Tall Soft types also aim to improve walking and have proven effective without significant side effects.

Overall, AFOs are designed to assist with walking and are often considered medically necessary. Reports of harm from using these devices are rare, making them a promising option for those needing support with leg movement. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring different types of Ankle-Foot Orthoses (AFOs) for musculoskeletal disorders. AFOs are typically used to support and align the ankle and foot, helping people walk more comfortably and safely. This trial is testing variations in design, such as short versus tall and firm versus soft, to see what combination works best. By comparing these different AFOs, researchers hope to discover which design provides the most effective support and comfort, potentially leading to more personalized and effective treatments for patients.

What evidence suggests that these AFO adjustments are effective for musculoskeletal disorders?

Research has shown that ankle foot orthoses (AFOs) can improve walking for individuals with muscle and bone issues. This trial will evaluate various AFOs, including the Short Firm, Short Soft, Tall Firm, and Tall Soft AFOs, each tested in different study arms. Studies have found that AFOs can increase walking speed, lengthen steps, and enhance gait, particularly for stroke recovery patients. The Short Firm AFO improves ankle movement, boosting walking speed and efficiency. The Short Soft AFO offers similar benefits, making walking easier and reducing energy use. The Tall Firm AFO supports the ankle with less bending, enhancing walking speed and movement. The Tall Soft AFO increases stability and reduces body sway, facilitating easier walking. Overall, different types of AFOs can support and improve everyday walking by enhancing lower leg movement. ^{5 6 7 8 9}

Who Is on the Research Team?

Jason M Wilken, PT, PhD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-70 who use an ankle foot orthosis (AFO) daily due to lower limb issues from injuries or musculoskeletal diseases. They must be able to walk 50 feet without help, have used their current AFO for over two weeks, and fit the AFO into regular shoes.

Inclusion Criteria

You meet the qualifications to be included in Group 1 of the study.

I can walk at a slow to moderate pace.

My ankle-foot orthosis fits in regular shoes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including comfort scores, ankle range of motion, and balance confidence

1 week

1 visit (in-person)

Testing

Participants walk with different AFO configurations to assess the effect of heel height and stiffness on gait

4 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for any changes in comfort and gait after testing

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Short Firm
• Short Soft
• Tall Firm
• Tall Soft

Trial Overview

The study tests how different heel heights and stiffness levels in AFOs affect walking. Participants will try out four types of heel cushions with varying properties during controlled walks, comparing these against their usual AFO setup and walking without an AFO if they can.

How Is the Trial Designed?

Group I: Arm 9: Experimental Treatment 4 Interventions

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

Group II: Arm 8: Experimental Treatment 4 Interventions

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

Group III: Arm 7: Experimental Treatment 4 Interventions

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

Group IV: Arm 6: Experimental Treatment 4 Interventions

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

Group V: Arm 5: Experimental Treatment 4 Interventions

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

Group VI: Arm 4: Experimental Treatment 4 Interventions

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

Group VII: Arm 3: Experimental Treatment 4 Interventions

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

Group VIII: Arm 2: Experimental Treatment 4 Interventions

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

Group IX: Arm 24: Experimental Treatment 4 Interventions

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

Group X: Arm 23: Experimental Treatment 4 Interventions

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

Group XI: Arm 22: Experimental Treatment 4 Interventions

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

Group XII: Arm 21: Experimental Treatment 4 Interventions

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

Group XIII: Arm 20: Experimental Treatment 4 Interventions

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

Group XIV: Arm 1: Experimental Treatment 4 Interventions

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

Group XV: Arm 19: Experimental Treatment 4 Interventions

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

Group XVI: Arm 18: Experimental Treatment 4 Interventions

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

Group XVII: Arm 17: Experimental Treatment 4 Interventions

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

Group XVIII: Arm 16: Experimental Treatment 4 Interventions

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

Group XIX: Arm 15: Experimental Treatment 4 Interventions

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

Group XX: Arm 14: Experimental Treatment 4 Interventions

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

Group XXI: Arm 13: Experimental Treatment 4 Interventions

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

Group XXII: Arm 12: Experimental Treatment 4 Interventions

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

Group XXIII: Arm 11: Experimental Treatment 4 Interventions

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

Group XXIV: Arm 10: Experimental Treatment 4 Interventions

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

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials

486

Recruited

934,000+

Published Research Related to This Trial

In a study involving 105 stroke patients, the therapist-made SWIFT Cast AFO was used significantly more during physical therapy sessions compared to conventional AFOs, indicating better integration into rehabilitation.

Despite higher usage of the SWIFT Cast, there was no significant improvement in walking speed compared to conventional therapy, suggesting that while it is a low-cost and adaptable option, it may not enhance recovery outcomes beyond standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Evaluation of the Efficacy of an Ankle-Foot Cast on Walking Recovery Early After Stroke: SWIFT Cast Trial. Pomeroy, VM., Rowe, P., Clark, A., et al.[2022]

A review of 25 studies found that the stiffness of ankle-foot orthoses (AFOs) significantly impacts ankle movement during walking, with greater stiffness leading to reduced ankle range of motion and altered kinematics.

Despite these effects on ankle mechanics, stiffness did not show consistent impacts on other joints like the hip or pelvis, nor on user preferences, highlighting the need for clearer design standards and further research in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of ankle-foot orthosis stiffness on gait: A systematic literature review. Totah, D., Menon, M., Jones-Hershinow, C., et al.[2022]

The study compared two types of low-temperature plastic anterior ankle foot orthoses (AFOs) and found that the anterior encased AFO is more effective in controlling ankle movements, particularly in patients with severe spastic hemiplegia.

The anterior direct molding AFO was significantly more flexible, with 2.6 times more flexibility in plantar flexion and 3 times more in inversion compared to the anterior encased AFO, suggesting that while it allows for more movement, it may not provide the necessary support for gait correction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A comparison of ankle fixation between two kinds of low-temperature plastic anterior ankle foot orthoses]. Chang, JJ., Lin, YT.[2015]

A study on ankle foot orthoses (AFOs) found that the placement of reinforcements significantly affects their stiffness, with optimal stiffness achieved when reinforcements are positioned at the front of the AFO.

Increasing the thickness of the AFO material and extending reinforcements from the footplate to at least two-thirds of the AFO's height can enhance rigidity, which is crucial for preventing buckling and ensuring effective support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A quantitative analysis of optimum design for rigid ankle foot orthoses: The effect of thickness and reinforcement design on stiffness. Chatzistergos, PE., Eddison, N., Ganniari-Papageorgiou, E., et al.[2023]

The study evaluated the stiffness of ankle foot orthoses (AFOs) in six patients, revealing that AFO stiffness varies significantly based on whether the device is designed for ankle support alone or for both ankle and knee support, which is crucial for tailoring treatment.

While the overall group did not show significant improvements in walking speed or push-off power with AFO use, some patients (good responders) maintained their push-off power and showed increased walking speed, suggesting that personalized AFO prescriptions could enhance rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study on the efficacy of AFO stiffness prescriptions. Vasiliauskaite, E., Ielapi, A., De Beule, M., et al.[2021]

The study quantitatively assessed the mechanical properties of articulated ankle-foot orthoses (AFOs) using different joint types and alignments, revealing that center alignment resulted in the least resistance and stiffness, which is beneficial for mobility.

It is recommended to avoid anterior and posterior alignments in AFOs, as they significantly increase resistance and stiffness, potentially leading to skin irritation and increased stress around the ankle joint.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of joint alignment and type on mechanical properties of thermoplastic articulated ankle-foot orthosis. Gao, F., Carlton, W., Kapp, S.[2014]

The flexibility of a shoehorn-type ankle-foot orthosis (AFO) in both dorsiflexion and plantarflexion is significantly influenced by the width of the ankle joint area, thickness of the plastic sheet, and height of the lateral wall, based on experimental assessments of various AFO designs.

Significant negative correlations were found between the angles of dorsiflexion and plantarflexion and several design factors, indicating that as these dimensions increase, the flexibility of the AFO decreases, which is crucial for optimizing AFO design for better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shoehorn-type ankle-foot orthoses: prediction of flexibility. Nagaya, M.[2019]

A survey of 100 UK orthotists revealed a strong consensus on the design of rigid ankle-foot orthoses (AFOs) for adult men, emphasizing the use of 4.5 mm copolymer polypropylene and a full-length footplate for optimal support.

The study identified specific design features, such as padded VELCRO straps and a height that finishes 2 cm below the fibular head, which are considered important for effective AFO prescription and patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescription practices for rigid ankle-foot orthoses among UK orthotists. Eddison, N., Gandy, M., Charlton, P., et al.[2023]

Citations

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This study aims to compare three orthotic ankle joint designs in AFOs for patients with muscle weakness in the plantarflexors and/or dorsiflexors.

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An AFO can improve functional performance and ambulation in survivors of strokes. · Wearing an AFO in rehabilitation care during the subacute phase post stroke ...

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We hypothesized that walking with the PD-AFO would significantly decrease total mechanical COT, increase gait speed, improve gait biomechanics ( ...

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pmc.ncbi.nlm.nih.gov/articles/PMC9329246/

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The aim of this scoping review was to identify information on compliance to wearing orthoses and other supportive devices, to discuss the barriers to adherence,

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pmc.ncbi.nlm.nih.gov/articles/PMC4357018/

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The results showed that equilibrium scores were significantly higher in experiments with the specially modified AFOs compared with conditions without AFOs.

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A prefabricated or off-the-shelf AFO is a premade orthosis often intended for short-term use or simple clinical conditions. If necessary ...

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Orthoses for neurological ankles

Custom moulded knee ankle foot orthosis. Moulded AFOs must be close fitting and cannot be used if oedema causes change in limb volume. This one also has a thigh ...