NCT07188415

CMT Gait, Mobility, Balance - AOFAS Grant

Lower Extremity Gait, Mobility and Balance Confidence in Charcot-Marie-Tooth Patients With Cavovarus Foot Deformity

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Bopha Chrea · Academic / Other
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The overall objective of the proposed research is to begin to better understand the potential benefits and limitations of ankle -foot orthosis (AFO) use in the context of mobility and balance during gait for individuals with Charcot-Marie-Tooth disease (CMT). These benefits will be studied in comparison to those offered by surgical correction. We will accomplish by having subjects undergo mobility and balance tests in our gait analysis lab.

Detailed description

Walking is an important daily activity that is compromised in individuals with neuromuscular conditions. Charcot-Marie-Tooth (CMT) disease is the most common form of inherited peripheral neuropathy, affecting 2.8 million people worldwide and 1 in 2500 in the United States. Amongst patients with CMT, impaired walking is the most significant contributor to reduced quality of life in patients with CMT. Furthermore, these gait deficits result in over 80% of individuals with CMT experiencing a fall or near fall event annually, primarily due to tripping and balance related issues. Ankle foot orthoses (AFOs) are commonly used by individuals with CMT, often with the intent of reducing the risk of falls and restoring a more normal gait pattern. However, AFOs are often bulky, uncomfortable, and can be destabilizing for already weak individuals. Surgical correction offers the advantage of improving limb alignment, reduces bulk, and the arduous nature of donning/doffing a brace. However, surgery is not without risk, potential complications, and post-operative recovery. Scientific evidence to help surgeons determine if an AFO or surgery are optimal for a given patient, especially in the setting of a brace-able foot, remains limited. Recent consensus among expert orthopaedic foot and ankle surgeons agrees that 'There is no evidence-based orthopedic studies to help determine optimal timing for surgery, and there is often contradictory advice from the patient's neurologist, physical therapist, and orthotist regarding the role of an operation. There is a critical need to understand how surgical correction affects mobility, balance confidence, and gait compared to AFO bracing in the native cavovarus foot (non-operatively treated). Without such information, the evidence-based approach to answering this critical question will likely remain unrealized.

Conditions

• Charcot Marie Tooth Disease (CMT)

Interventions

Type	Name	Description
DEVICE	Ankle-foot Orthoses	Group 1 will consist of individuals who have CMT and have undergone surgical correction (OP) and Group 2 will be AFO users who have CMT but have not undergone major surgical correction (NonOP).

Timeline

• Start date: 2025-08-14
• Primary completion: 2026-08-01
• Completion: 2027-01-01
• First posted: 2025-09-23
• Last updated: 2025-09-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study