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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how adjustable ankle braces, specifically the Differential and Adjustable Stiffness Ankle Foot Orthosis (DAS-AFO), might improve walking for people with cerebral palsy (CP). The study will test whether these braces enhance walking performance and biomechanics compared to other brace designs or walking without braces. Participants will use the new adjustable brace, their usual brace, and no brace to compare the effects. The trial seeks individuals diagnosed with CP who can walk on a treadmill for six minutes and use a specific type of ankle brace. As an Early Phase 1 trial, this research aims to understand how the new brace works in people, offering participants a chance to be among the first to experience its potential benefits.

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 prior data suggests that these adjustable ankle braces are safe for use in cerebral palsy?

Research shows that adjustable stiffness ankle braces, such as the DAS-AFO, are under study to assess their impact on walking in people with cerebral palsy. Current studies lack specific safety information about these braces. As this trial is in its early stages, researchers continue to evaluate their safety.

Early trials typically aim to determine if a treatment is safe for use. While the DAS-AFO appears promising, more information is needed to understand its usability without issues. Participants in the trial will help researchers gather crucial safety data. So far, studies have not reported any negative effects or side effects from this type of brace. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Adjustable Ankle Braces for Cerebral Palsy, or DAS-AFO, is unique because it offers differential and adjustable stiffness, which is a game-changer for individuals with cerebral palsy. Unlike standard ankle-foot orthoses (AFOs) that have a fixed stiffness, DAS-AFOs allow for customization to better match the user's specific walking needs and comfort. This adaptability can lead to improved mobility and independence, making it a promising option for enhancing the quality of life for those affected by cerebral palsy. Researchers are excited because this treatment could potentially offer a more personalized and effective solution compared to conventional AFOs.

What evidence suggests that this adjustable ankle brace is effective for cerebral palsy?

Research shows that the Differential and Adjustable Stiffness Ankle Foot Orthosis (DAS-AFO), used by participants in this trial, can help people with cerebral palsy walk better. Studies have found that this new brace design increases ankle movement and enhances the power used to push the body forward while walking. Other findings suggest that DAS-AFOs improve overall walking ability and ease adaptation to different activities, like standing up or sitting down. Although specific data on DAS-AFOs remains limited, ankle braces in general often help people with cerebral palsy walk better. These early results are promising for improving mobility in individuals with cerebral palsy. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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

No condition other than CP that would affect safe participation

Exclusion Criteria

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40659983/

Differential and Adjustable Stiffness Leaf Spring Ankle Foot ... Our findings highlight potential benefits of the DAS-AFO design over solid AFOs, including improved ankle joint motions and push-off power ...

2. researchgate.net researchgate.net/publication/393694974_Differential_and_Adjustable_Stiffness_Leaf_Spring_Ankle_Foot_Orthoses_Enhance_Gait_Propulsion_and_Task_Versatility_in_Cerebral_Palsy

Differential and Adjustable Stiffness Leaf Spring Ankle Foot ... This study explored the effectiveness of a novel differential and adjustable stiffness leaf spring AFO (DAS-AFO) during standing, walking, and sit-to-stand ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06262191

Testing an Adjustable Ankle Orthosis During Walking in ... This study seeks to determine how an adjustable stiffness ankle braces affects walking performance and biomechanics in cerebral palsy. Detailed Description. Our ...

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0142878

The Effects of Varying Ankle Foot Orthosis Stiffness on Gait in ... This study investigated the effects of varying AFO stiffness on gait biomechanics and efficiency in children with CP who walk with excessive knee flexion in ...

5. withpower.com withpower.com/trial/early-phase-1-cerebral-palsy-2-2024-8b42a

Adjustable Ankle Braces for Cerebral Palsy Although specific data on DAS-AFO is not provided, the general effectiveness of AFOs in improving gait suggests potential benefits. Show more ...

6. journals.lww.com journals.lww.com/jpojournal/fulltext/2025/07000/effectiveness_of_ankle_foot_orthoses_for_patients.11.aspx

Effectiveness of Ankle-Foot Orthoses for Patients with... This study aims to compare three orthotic ankle joint designs in AFOs for patients with muscle weakness in the plantarflexors and/or dorsiflexors.