Adjustable Ankle Braces for Cerebral Palsy

Age: < 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Northern Arizona University

Disqualifiers: Excessive knee flexion

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

11 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications, but it mentions that no concurrent treatment other than those assigned during the study is allowed.

What data supports the effectiveness of the treatment Differential and adjustable stiffness AFO (DAS-AFO) for cerebral palsy?

Research shows that different types of ankle-foot orthoses (AFOs) can affect walking patterns in children with cerebral palsy, with some children preferring articulated braces for better movement. Although specific data on DAS-AFO is not provided, the general effectiveness of AFOs in improving gait suggests potential benefits. ^{1 2 3 4 5}

Is the adjustable ankle brace safe for use in humans?

The research does not provide specific safety data for adjustable ankle braces, but they are generally used in children with cerebral palsy without reported safety concerns. ^{1 2 5 6 7}

What makes the DAS-AFO treatment unique for cerebral palsy?

The Differential and Adjustable Stiffness Ankle Foot Orthosis (DAS-AFO) is unique because it allows for adjustable stiffness, which can be tailored to the specific needs of each child with cerebral palsy, potentially improving their walking ability and comfort compared to standard AFOs that have fixed stiffness. ^{1 8 9 10 11}

What is the purpose of this trial?

This study seeks to determine how an adjustable stiffness ankle braces affects walking performance and biomechanics in cerebral palsy.

Eligibility Criteria

This trial is for individuals aged 8-35 with cerebral palsy who can walk on a treadmill and have not had surgery in the last 6 months. They should not be receiving other treatments during the study, have no other conditions affecting safety, and must typically use physician-prescribed ankle braces.

Inclusion Criteria

I am between 8 and 35 years old.

No concurrent treatment other than those assigned during the study

I can walk and move with some level of independence.

Exclusion Criteria

My CP causes my knees to bend too much when I walk.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will walk with the new AFO, their own AFOs, and no AFOs to assess walking performance and biomechanics

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Differential and adjustable stiffness AFO (DAS-AFO)

Trial Overview The study is testing an adjustable stiffness ankle brace (DAS-AFO) to see how it changes walking performance and movement patterns in people with cerebral palsy during treadmill walking exercises.

Participant Groups

Group I: Study group Experimental Treatment 1 Intervention

Participants will walk with the new AFO, their own AFOs, and no AFOs.

Who Is Running the Clinical Trial?

Northern Arizona University

Lead Sponsor

Trials

36

Recruited

6,300+

Findings from Research

In a study of 26 children with cerebral palsy, those wearing hinged ankle-foot orthoses (HAFO) demonstrated better standing reach, longer stride length, and faster walking speed compared to those wearing solid ankle-foot orthoses (SAFO).

Parents preferred HAFO due to better cost-to-benefit ratios, although overall mobility scores did not significantly differ between the two orthosis types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidimensional Effects of Solid and Hinged Ankle-Foot Orthosis in Children With Cerebral Palsy. Limpaninlachat, S., Prasertsukdee, S., Palisano, RJ., et al.[2023]

A systematic review of 41 studies on ankle-foot orthoses (AFOs) for children with cerebral palsy revealed significant variability in the reporting quality, making it difficult to compare outcomes across studies.

The review led to the development of best practice guidelines for future research, emphasizing the need for detailed descriptions of participant characteristics and orthosis designs to improve the reliability and replicability of findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review to determine best practice reporting guidelines for AFO interventions in studies involving children with cerebral palsy. Ridgewell, E., Dobson, F., Bach, T., et al.[2022]

In a study of 14 children with spastic diplegic cerebral palsy, different types of ankle-foot orthoses (AFOs) were evaluated, revealing that while AFOs showed abnormal ankle movement, shoes alone approached normal kinematic data.

Most children preferred articulated or posterior leaf-spring braces over solid braces, indicating a potential preference for more flexible support options in improving comfort and usability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of the effects of solid, articulated, and posterior leaf-spring ankle-foot orthoses and shoes alone on gait and energy expenditure in children with spastic diplegic cerebral palsy. Smiley, SJ., Jacobsen, FS., Mielke, C., et al.[2022]

Ankle foot orthoses (AFOs) significantly improve gait parameters in children with cerebral palsy, with notable increases in stride length and ankle dorsiflexion, particularly in those with hemiplegia.

The study involved 56 children with cerebral palsy, showing that AFOs enhanced walking stability and symmetry, with a tripling of patients achieving symmetry during double support phases, indicating effective support for mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of community-prescribed ankle-foot orthoses on gait parameters in children with spastic cerebral palsy. Hayek, S., Hemo, Y., Chamis, S., et al.[2021]

The study involved 88 children, including 28 with cerebral palsy using adjustable splint-assisted ankle-foot orthoses (AFO), and showed that this method significantly improved the heel/forefoot ratio, indicating a reduction in equinus deformity over 12 months.

In comparison, children using static AFOs showed less improvement, suggesting that the adjustable splint-assisted AFO is a more effective treatment option for managing equinus deformities in children with cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conservative treatment for equinus deformity in children with cerebral palsy using an adjustable splint-assisted ankle-foot orthosis. Chen, W., Liu, X., Pu, F., et al.[2021]

In a study of 80 children with spastic cerebral palsy, those who wore ankle foot orthoses (AFOs) for 6-12 hours per day reported significantly better quality of life, daily living activities, and parental satisfaction compared to those who wore them for 12-24 hours per day.

The findings suggest that longer AFO-wearing times may not improve physical function and could negatively impact activity levels and satisfaction, indicating that AFO usage should be tailored to individual needs rather than strictly increased.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of body structure, function, activity, and participation levels according to ankle foot orthosis wearing time in children with spastic cerebral palsy. Unes, S., Coskun, G., Kerem Gunel, M.[2023]

In a study involving 10 children with cerebral palsy, both dynamic ankle-foot orthoses (DAFOs) and adjustable dynamic response ankle-foot orthoses (ADR-AFOs) improved gait parameters compared to walking barefoot, showing better stride length and hip extension.

While ADR-AFOs provided superior knee extension and push-off power, DAFOs were associated with higher parent satisfaction and increased walking activity, indicating that both types of braces have unique benefits for children with cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of 2 Orthotic Approaches in Children With Cerebral Palsy. Wren, TA., Dryden, JW., Mueske, NM., et al.[2022]

References

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

Multidimensional Effects of Solid and Hinged Ankle-Foot Orthosis in Children With Cerebral Palsy. [2023]

2. France pubmed.ncbi.nlm.nih.gov

A systematic review to determine best practice reporting guidelines for AFO interventions in studies involving children with cerebral palsy. [2022]

3. England pubmed.ncbi.nlm.nih.gov

How does a systematic tuning protocol for ankle foot orthosis-footwear combinations affect gait in children in cerebral palsy? [2023]

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

A comparison of the effects of solid, articulated, and posterior leaf-spring ankle-foot orthoses and shoes alone on gait and energy expenditure in children with spastic diplegic cerebral palsy. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The effect of community-prescribed ankle-foot orthoses on gait parameters in children with spastic cerebral palsy. [2021]

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

The effect of fixed ankle foot orthoses in children with cerebral palsy. [2019]

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

Conservative treatment for equinus deformity in children with cerebral palsy using an adjustable splint-assisted ankle-foot orthosis. [2021]

8. France pubmed.ncbi.nlm.nih.gov

Comparison of body structure, function, activity, and participation levels according to ankle foot orthosis wearing time in children with spastic cerebral palsy. [2023]

9. France pubmed.ncbi.nlm.nih.gov

A series of case studies on the effect of a midfoot control ankle foot orthosis in the prevention of unresolved pressure areas in children with cerebral palsy. [2017]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of ankle foot orthoses types on walking in children with cerebral palsy: A systematic review. [2022]

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

Comparison of 2 Orthotic Approaches in Children With Cerebral Palsy. [2022]