Ankle-foot Orthoses for CMT

Overseen By Lauren Crowe, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Bopha Chrea

Disqualifiers: Diabetes, ETOH abuse, others

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

Compensation: Varies

Number of Visits: 1

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how ankle-foot orthoses (AFOs) can enhance mobility and balance in individuals with Charcot-Marie-Tooth disease (CMT). Researchers aim to compare the effectiveness of AFOs with surgery for correcting foot deformities caused by CMT. Participants will undergo walking and balance tests in a lab setting. The trial seeks individuals diagnosed with CMT who can walk without an AFO and either currently use an AFO or have undergone surgery for CMT. As an unphased trial, this study provides a unique opportunity to contribute to understanding non-surgical options for improving mobility in CMT patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that ankle-foot orthoses are safe for individuals with Charcot-Marie-Tooth disease?

Research has shown that ankle-foot orthoses (AFOs) are often used by people with Charcot-Marie-Tooth (CMT) disease. These devices help reduce foot pain and facilitate movement. One study found that foot pain decreased by 18% from the first visit to the second after using AFOs. However, some individuals experienced more emotional distress and found AFOs less comfortable than alternatives like shoe inserts or orthopedic shoes.

While AFOs can aid in movement and pain relief, they might not be the most comfortable choice for everyone. Although no serious safety concerns have been reported, it is important to consider both the emotional and physical comfort of these devices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using ankle-foot orthoses (AFOs) for Charcot-Marie-Tooth (CMT) disease because they offer a non-surgical approach to enhancing mobility and stability. Unlike surgical corrections, which can be invasive and come with longer recovery times, AFOs can be worn and adjusted easily to provide immediate support. This makes them a flexible option for patients who haven't undergone surgery, allowing them to experience improvements in walking and balance without the need for an operation.

What evidence suggests that ankle-foot orthoses are effective for Charcot-Marie-Tooth disease?

Research shows that ankle-foot orthoses (AFOs) can improve walking in people with Charcot-Marie-Tooth disease (CMT). Studies have found that AFOs can lengthen steps and increase walking speed. They also ease walking and reduce movement problems. In this trial, one group of participants will use AFOs, while another group will consist of those who have undergone surgical correction and do not use AFOs. However, not everyone continues to use these devices; some experience issues and stop using them over time. Overall, AFOs are often recommended to help people with CMT move more easily. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals aged 12-75 with Charcot-Marie-Tooth disease (CMT) who can walk unaided at a slow to moderate pace and have either been prescribed ankle-foot orthoses (AFOs) or undergone surgical correction for CMT. Participants must be able to read/write in English and provide consent. Excluded are those with other neuropathies, visual impairments, history of relevant surgeries, significant pain while walking, or risk of not completing the study.

Inclusion Criteria

I am between 12 and 75 years old.

Able to read and write in English and provide written informed consent

I can walk at a slow to moderate pace without using an ankle-foot orthosis.

Exclusion Criteria

Other causes or risk factors for peripheral neuropathy (e.g., diabetes, ETOH abuse)

Concern by the examiner that the individual will not complete the study

I have vision problems that glasses or contacts can't fix.

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 the Four-Square Step Test, Self-selected Walking Velocity, Activity Specific Balance Confidence Scale, Falls Frequency Questionnaire, and Lower Extremity Gait Biomechanics

1 day

1 visit (in-person)

Intervention

Participants in the NonOP group complete study procedures both with and without their AFOs, while OP group participants are assessed post-surgery without AFOs

Varies

Follow-up

Participants are monitored for changes in mobility, balance confidence, and gait

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ankle-foot Orthoses

Trial Overview The study aims to compare the benefits and limitations of using AFOs versus surgical correction on mobility and balance during gait in CMT patients. Tests will be conducted in a gait analysis lab to assess how these interventions affect movement.

How Is the Trial Designed?

Group I: NonOP Experimental Treatment 1 Intervention

Charcot-Marie-Tooth patients who have not undergone surgical correction, but do wear clinically prescribed ankle-foot orthoses. NonOP subjects will complete study procedures both with and without their AFOs.

Group II: OP Active Control 1 Intervention

Charcot-Marie-Tooth patients who have undergone surgical correction but do not wear ankle-foot orthoses.

Who Is Running the Clinical Trial?

Bopha Chrea

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7784614/

Satisfaction with ankle foot orthoses in individuals with ... The aim of this study was to evaluate patient reported satisfaction with orthotic devices and services in individuals with CMT to provide preliminary data.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0966636221000436

The impact of orthoses on gait in children with Charcot- ... AFOs can increase stride length and walking velocity in children with CMT. ... Ankle-foot-orthoses (AFOs) can improve stance and/or swing phase gait issues.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/jfa2.70003

The effect of ankle‐foot orthoses on gait characteristics in ... Ankle-foot orthoses (AFOs) are commonly prescribed for people with Charcot-Marie-Tooth disease (CMT) to improve gait efficiency and reduce the ...

4. jnnp.bmj.com jnnp.bmj.com/content/early/2023/11/02/jnnp-2023-332422

Use, tolerability, benefits and side effects of orthotic devices in ... Although 70% of patients were prescribed foot orthoses, 19% of them did not use the devices, 31% of users later abandoned them and 59% experienced complications ...

5. 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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11041609/

Use, tolerability, benefits and side effects of orthotic ... AFO users experienced greater emotional distress and reduced tolerability as compared with shoe inserts (p<0.001) and orthopaedic shoes (p=0.003 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07188415

Study Details | NCT07188415 | CMT Gait, Mobility, Balance Ankle foot orthoses (AFOs) are commonly used by individuals with CMT, often with the intent of reducing the risk of falls and restoring a ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41084116/

Perception of ankle foot orthoses by individuals with Charcot ... These data emphasize areas of improvement for orthotic treatment relevant to individuals with CMT and which may help guide future research ...

9. researchgate.net researchgate.net/publication/49789678_Ankle_foot_orthoses_for_people_with_Charcot_Marie_Tooth_disease_-_Views_of_users_and_orthotists_on_important_aspects_of_use

Ankle foot orthoses for people with Charcot Marie Tooth ... The results demonstrate a significant reduction in foot pain (p<0.001) from initial visit to second visit (18% reduction in pain). A significant ...