AFO Adjustments for Musculoskeletal Disorders

(AFOHeel Trial)

Overseen By Kirsten M Anderson, BSE

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

Trial Summary

What is the purpose of 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.

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 data supports the effectiveness of the treatment AFO Adjustments for Musculoskeletal Disorders?

Research shows that different types of ankle-foot orthoses (AFOs) can provide varying levels of support and flexibility, which are important for controlling foot and ankle movements. For example, anterior encased AFOs are more effective in controlling certain movements like plantar flexion (pointing the foot down) and inversion (turning the foot inward) compared to other designs, which can be beneficial for conditions like severe spastic hemiplegia (muscle stiffness on one side of the body). ^{1 2 3 4 5}

How does the AFO treatment differ from other treatments for musculoskeletal disorders?

The AFO (ankle-foot orthosis) treatment is unique because it focuses on adjusting the stiffness and design of the orthosis to provide specific support during walking, which can be tailored to individual needs. This approach contrasts with standard treatments that may not offer such personalized adjustments in stiffness and flexibility. ^{1 5 6 7 8}

Research Team

Jason M Wilken, PT, PhD

Principal Investigator

University of Iowa

Eligibility Criteria

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

I am between 18 and 70 years old.

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

I can walk at a slow to moderate pace.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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 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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

A study on the efficacy of AFO stiffness prescriptions. [2021]

2. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

[A comparison of ankle fixation between two kinds of low-temperature plastic anterior ankle foot orthoses]. [2015]

3. France pubmed.ncbi.nlm.nih.gov

Prescription practices for rigid ankle-foot orthoses among UK orthotists. [2023]

4. United States 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. [2022]

5. France 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

The impact of ankle-foot orthosis stiffness on gait: A systematic literature review. [2022]

7. France pubmed.ncbi.nlm.nih.gov

Effects of joint alignment and type on mechanical properties of thermoplastic articulated ankle-foot orthosis. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

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