AFO Adjustments for Musculoskeletal Disorders

(AFOHeel Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Jason M Wilken, PT, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Iowa

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

No Placebo Group

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).

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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.

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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.

Trial 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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Iowa Iowa City, IA

Who Is Running the Clinical Trial?

University of Iowa Lead Sponsor

References

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

A study on the efficacy of AFO stiffness prescriptions. [2021] Ankle foot orthosis (AFO) stiffness is a key characteristic that determines how much support or restraint an AFO can provide. Thus, the goal of the current study is twofold: (1) to quantify AFO prescriptions for a group of patients; (2) to evaluate what impact these AFO have on the push-off phase.

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] The low-temperature ankle foot orthosis (AFO) was designed in the anterior leaf type, called anterior AFO, to meet the need of indoor barefoot walking. It could be easily molded and remolded to fit the foot, as well as to adjust the position of the foot and ankle. Two kinds of low-temperature plastic anterior ankle foot orthoses, anterior encased and anterior direct molding ankle foot orthoses, were compared to analyze the effectiveness of ankle fixation in plantar flexion and inversion. Force was applied to each of the anterior AFOs at the anterior-middle and anterior-lateral sides to simulate the movement of ankle plantar flexion and inversion. At the same time, the deformation in plantar flexion and inversion of both anterior AFOs were recorded to analyze the relationship between force and the deformed angle. The results showed that plantar flexion deformed angles of the anterior direct molding AFO were 2.6 times more flexible than anterior encased AFO. The ankle inversion deformed angles of the anterior direct molding AFO were 3 times more flexible than the anterior encased AFO in inversion. These results support our belief that anterior encased AFO is more effective in controlling ankle plantar flexion and inversion than anterior direct molding AFO, especially for severe spastic hemiplegia in gait correction.

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

Prescription practices for rigid ankle-foot orthoses among UK orthotists. [2023] The purpose of this study was to investigate rigid ankle-foot orthosis (AFO) prescription practices for adult men among UK orthotists.

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] Timely provision of an ankle-foot orthosis (AFO) orthotist customized for individuals early after stroke can be problematic.

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] An ankle foot orthosis (AFO) which is prescribed to be rigid should only deform a small amount to achieve its clinical goals. Material thickness and the design of reinforcing features can significantly affect AFO rigidity, but their selection remains based on anecdotal evidence.

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

The impact of ankle-foot orthosis stiffness on gait: A systematic literature review. [2022] Ankle-foot orthoses (AFOs) are commonly prescribed to provide ankle support during walking. Current prescription standards provide general guidelines for choosing between AFO types, but are limited in terms of guiding specific design parameter choices. These design parameters affect the ankle stiffness of the AFO.

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

Effects of joint alignment and type on mechanical properties of thermoplastic articulated ankle-foot orthosis. [2014] Articulated or hinged ankle-foot orthosis (AFO) allow more range of motion. However, quantitative investigation on articulated AFO is still sparse.

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

Shoehorn-type ankle-foot orthoses: prediction of flexibility. [2019] To predict the factors affecting the flexibility of a shoehorn-type ankle-foot orthosis (AFO) in dorsiflexion and plantarflexion.